Immediate Placement of the Straumann® Bone Level Tapered Implant With Early Loading in Single Tooth Gaps in the Maxilla and Mandible Compared to Delayed Placement
Phase: NA
Conditions: Tooth Loss
Sponsor: Institut Straumann AG

lstraumann 
Immediate Placement of the Straumann® Bone Level Tapered Implant with 
Early Loading in Single Tooth Gaps in the Maxilla and Mandible Compared 
to Delayed Placement 
Protocol reviewed and approved by: 
David L. Cochran, DDS 
Principal Investigator 
Disha Jetani 
Clinical Study Manager 
Sarah Hackett 
Senior Manager, Clinical 
Research 
Michel Mallaun, PhD 
Head of Clinical Operations 
PROPRIETARY INFORMATION 
CR 01/14 
Date: 29- Mar-2018 
Version 5.0 
Signature 
Signature 
Signature 
Signature 
Date 
Date 
Date 
Date 
This protocol contains information that is confidential and proprietary to Institute Straumann AG, 
Switzerland. The information has been provided to you for the sole purpose of conducting a 
clinical trial for Straumann or for evaluating your potential participation in such a trial. The 
information may be disclosed to the Ethics Committee or Institutional Review Board of your 
institution and to personnel who are expected to participate in the study. The information 
contained in this protocol, its appendices or supplements, the existence of such a protocol or 
the fact of or content of discussions with Straumann must not be revealed to any other parties 
without the written permission of Straumann in advance, unless such disclosure is mandated by 
government laws or regulations. 

Contact Information 
Coordinating Investigator: 
David L. Cochran, DDS, PhD, MMSci 
University of Texas Health Science 
Center San Antonio 
Department of Periodontics, MSC 7894 
7703 Floyd Curl Drive 
San Antonio, TX 78229 
USA 
(210) 567-3604 - Phone 
(210) 567-3643- Fax 
cochran@uthscsa.edu 
Principal Investigator: 
Michael P. Mills, DMD, MS 
University of Texas Health Science 
Center San Antonio 
Department of Periodontics, MSC 7894 
7703 Floyd Curl Drive 
San Antonio, TX 78229 
USA 
(210) 567-0416 - Phone 
(210) 567-3761 - Fax 
mills@uthscsa.edu 
Principal Investigator: 
William C. Martin, DMD, MS 
Director, Center for Implant Dentistry 
University of Florida - College of Dentistry 
1395 Center Drive, RM D7-6 
Gainesville, FL 32610-0434 
USA 
(352) 273-6715 - Phone 
(352) 392-0979 - Fax 
wmartin@dental.ufl.edu 
Protocol Version 5.0, 29-Mar-2018 
Page 2 of 84 

Principal Investigator: 
Sponsor: 
Sponsor Representatives: 
Study Manager: 
Study Manager: 
Protocol Version 5.0, 29-Mar-2018 
Tara Aghaloo, DDS, MD, PhD 
UCLA School of Dentistry 
10833 Le Conte Avenue 
53-009 CHS 
Los Angeles, CA 90095-1668 
310-794-7070 
tag haloo@dentistry. ucla. edu 
lnstitut Straumann AG 
Peter Merian Weg 12 
CH- 4002 Basel 
Switzerland 
Sarah Hackett 
Senior Manager, Clinical Research 
Straumann USA, LLC 
60 Minuteman Road 
Andover, MA 01810 
USA 
(978) 747-2533 - Phone 
(978) 747-0023 - Fax 
sarah.hackett@straumann.com 
Disha Jetani 
Clinical Study Manager 
Straumann USA, LLC 
60 Minuteman Road 
Andover, MA 01810 
USA 
(978) 747-2582 - Phone 
(978) 747-0023 - Fax 
disha.jetani@straumann.com 
Page 3 of 84 

Head of Clinical Operations: 
Protocol Version 5.0, 29-Mar-2018 
Michel Mallaun, PhD 
lnstitut Straumann AG 
Peter Merian Weg 12 
CH- 4052 Basel 
Switzerland 
Phone: +41 61 965 14 23 
Fax: +41619651110 
Email: michel.mallaun@straumann.com 
Page 4 of 84 

Abbreviations 
0 
Diameter 
ADA 
American Dental Association 
ADE 
Adverse Device Effect 
AE 
Adverse Event 
ASADE 
Anticipated Serious Adverse Device Effect 
BLT 
Bone Level Tapered 
CBCT 
Cone Beam Computed Tomography 
CFR 
Code of Federal Regulations 
CRF 
Case Report Form 
DD 
Device Deficiencies 
eCRF 
Electronic Case Report Form 
EDC 
Electronic Data Capture 
FDA 
Food and Drug Administration 
GBR 
Guided Bone Regeneration 
GCP 
Good Clinical Practice 
GTR 
Guided Tissue Regeneration 
IFU 
Instructions for Use 
IRB 
Institutional Review Board 
ISO 
International Organization for Standardization 
ISQ 
Implant Stability Quotient 
Protocol Version 5.0, 29-Mar-2018 
Page 5 of 84 

ITT 
Intention To Treat population 
mlTT 
Modified Intention to Treat 
mm 
Millimeter 
mSBI 
modified Sulcus Bleeding Index 
Nern 
Newton centimeter 
pp 
Per Protocol population 
PPD 
Probing Pocket Depth 
PSP 
Photostimulable Phosphor 
RFA 
Resonance Frequency Analysis 
SADE 
Serious Adverse Device Effect 
SAE 
Serious Adverse Event 
SAF 
Safety Population 
USADE 
Unanticipated Serious Adverse Device Effect 
VAS 
Visual Analog Scale 
Protocol Version 5.0, 29-Mar-2018 
Page 6 of 84 

Synopsis 
Study Title: 
Study Protocol 
Number: 
Study Registration: 
Objectives: 
Study Design: 
Subject Population: 
Inclusion Criteria: 
Immediate Placement of the Straumann® Bone Level Tapered Implant with 
Early Loading in Single Tooth Gaps in the Maxilla and Mandible Compared to 
Delayed Placement as Control 
CR 01/14 
This protocol will be registered at clinicaltrials.gov before enrollment begins. 
The aim of this randomized, controlled, multi-center study is to assess the 
clinical and radiographic outcomes of using a Straumann® Bone Level 
Tapered implant for immediate implantation following extraction of a tooth in 
the pre-molar and anterior region of the maxilla and mandible (test) compared 
to the outcomes of placing this implant in healed sites (control). 
The primary objective is to demonstrate that the change in mean peri-
implant marginal bone level changes (mesial and distal) from loading to 12 
months post-loading of the test treatment will be no worse than the control 
treatments. 
The secondary objectives of the study are to assess differences in clinical 
and radiographic outcomes between the test and control treatments at 12 
months post-loading by looking at implant success and survival, buccal bone 
dimensional changes, implant stability, soft tissue changes, subject 
satisfaction, and adverse events. 
An additional objective is to assess long-term differences in clinical and 
radiographic outcomes, as measured in the primary and secondary 
objectives, over the span of five years. 
Post-market, prospective, randomized, controlled, multi-center study 
Male or female subjects 18 years of age or older who are in need of a single 
tooth extraction in the pre-molar or anterior region of the mouth and 
replacement with a dental implant; and meet all of the inclusion/exclusion 
criteria listed below. 
• 
Subjects must have voluntarily signed the informed consent form before 
any study related procedures 
• 
Subjects must be males or females who are a minimum of 18 years of 
age 
• 
Subjects who are in need of a single tooth extraction in the pre-molar or 
anterior region of the maxilla or mandible (ADA tooth positions 4-13 and 
20-29) and replacement with a dental implant. 
• 
Implants must be placed either immediately in an extraction socket or 
placed in a healed site (greater than 4 months healing) which has not 
been previously grafted. 
• 
Planned site for implant must have a natural tooth both mesially and 
distally in the adjacent tooth positions 
• 
Subjects must have opposing dentition (natural teeth, fixed or removable 
restorations) 
• 
There must be sufficient bone at the implant site to achieve primary 
stability 
• 
Subjects must be committed to the study and the required follow-up visits 
Protocol Version 5. 0, 29-Mar-2018 
Page 7 of 84 

• 
Subjects must be in good general health as assessed by the Investigator 
• 
Subjects with a systemic disease that would preclude dental implant 
surgery 
• 
Subjects with any contraindications for oral surgical procedures 
• 
Subjects with mucosal diseases (e.g., erosive lichen planus) in the 
localized area around the study implant site 
• 
Subjects with a history of local irradiation therapy in the head/neck area 
• 
Subjects with any untreated endodontic lesions or untreated periodontal 
disease adjacent to the implant site 
• 
Subjects receiving, or having a history of receiving, intravenous or 
subcutaneous antiresorptive agents, such as bisphosphonates 
• 
Subjects with severe bruxing, parafunctional habits, or 
temporomandibular joint dysfunction 
• 
Any implant sites where there will be a buccal dehiscence greater than 3 
mm or there will be a fenestration of the implant 
Exclusion Criteria: 
• 
Subjects with inadequate oral hygiene or who are unmotivated for 
adequate home care 
• 
Subjects who have physical or mental handicaps that would interfere with 
the ability to perform adequate oral hygiene 
• 
Subjects who are pregnant or intending to become pregnant during the 
duration of the study 
• 
Subjects who are heavy smokers (defined as >10 cigarettes per day or 
>1 cigar per day) or chew tobacco 
• 
Subjects who abuse alcohol or drugs 
• 
Subjects who have undergone administration of any investigational 
device within 30 days of enrollment in the study 
• 
Subjects with conditions or circumstances, in the opinion of the 
investigator, which would prevent completion of study participation or 
interfere with analysis of study results, such as history of non-compliance 
or unreliability 
Visit# 
Visit 
Schedule 
Visit 1 
Screening 
< 45 days from tooth extraction 
Visit 2a 
Tooth Extraction and 
Randomization 
Visit 2b 
Implant Surgery 
Immediately at tooth extraction OR 
17 weeks after tooth extraction 
Treatment Plan: 
Visit 3 
Immediate Post-Operative 
10 days after implant placement 
Uncover Implant 
10 weeks ± 3 weeks after implant 
Visit 4 
(impression/index for 
placement 
provisional) 
Visit 5 
Implant Loading 
10 weeks ± 3 weeks post implant 
placement 
Visit 6 
Impression (for final 
5 weeks post-loading 
restoration) 
Protocol Version 5.0, 29-Mar-2018 
Page 8 of 84 

Visit 7 
Final Restoration 
10 weeks post-loading 
Visit 8 
6-month follow-up 
6 months post-loading 
Visit 9 
Primary Endpoint 
12 months post-loading 
Visit 10 
Additional follow-up 
24 months post-loading 
Visit 11 
Additional follow-up 
36 months post-loading 
Visit 12 
Additional follow-up 
48 months post-loading 
Visit 13 
Additional follow-up 
60 months post-loading 
Straumann® Bone Level Tapered implants with the SLActive® surface and 
Study Products: 
Roxolid material, endosteal diameter 3.3 mm, 4.1 mm, and 4.8 mm, available 
in lengths of 8, 10, 12, 14 and 16 mm. 
Straumann® Bone Level Tapered implants with the SLActive® surface are CE 
Registration Status: 
marked products and are subject of cleared 51 0(k) pre-market notifications 
K140878 and will be used within the cleared indications. 
Primary Analysis: 
The primary analysis will be conducted after all subjects complete the 12 
months post-loading visit. Baseline is implant loading. 
Primary Parameters: 
• 
Mean crestal bone level change 
• 
Implant success and survival 
• 
Dimensional changes of the buccal bone measured on cone beam 
computed tomography images 
• 
Implant stability as measured by resonance frequency analysis 
Secondary Parameters 
(implant placement, implant loading, and final restoration) 
• 
Changes in soft tissue (gingival and papilla margins - baseline at 
final restoration) 
• 
Subject satisfaction (esthetics, function, and level of pain) 
• 
Adverse events and adverse device effects incidence 
Additional Analysis: 
Additional analysis will be done at 24, 36, 48, and 60 months post-loading 
• 
Mean crestal bone level changes 
• 
Implant success and survival 
Additional Analysis 
• 
Buccal bone dimensional changes measured on CBCT images 
Parameters: 
• 
Changes in soft tissue (gingival and papilla margins) 
• 
Subject satisfaction (esthetics, function, and level of pain) 
• 
Adverse events and adverse device effects incidence 
The hypothesis is the mean change in crestal bone from implant loading to 12 
Statistical 
months post-loading for the test group (immediate implant placement in an 
Considerations 
extraction socket) will be non-inferior to the mean change in crestal bone 
level for the control group (implant placement in a healed site). 
Safety 
The subjects will be monitored for adverse events by the investigators until 
the end of follow-up for each subject. 
Countries in which the 
Study will be 
United States 
performed 
Protocol Version 5.0, 29-Mar-2018 
Page 9 of 84 

Number of 
3 centers 
participating centers 
Study Principal 
David L. Cochran, DDS, MS, PhD 
Investigator 
William Martin, DMD, University of Florida 
Principal Investigators 
Michael P. Mills, DMD, MS, University of Texas Health Science Center San 
at Centers: 
Antonio 
Tara Aghaloo, DDS, MD, PhD, University of California at Los Angeles 
Number of Subjects 
52 subjects (randomized 1: 1 to test or control) 
Estimated Date of 
03 2015 
Study Initiation 
Estimated Date of 
02 2018 for all subjects to reach the primary endpoint; 
Study Completion 
02 2022 for all subjects to complete the follow-up phase. 
Sponsor 
lnstitut Straumann AG 
This study and any amendments will be performed according to ISO 
14155:2011, ICH E6(R1) Guideline on Good Clinical Practice (GCP) 1996, 
Compliance 
and conformed to the Declaration of Helsinki (last revised Fortaleza 2013). 
Local legal and regulatory requirements include compliance with 21 CFR 50, 
21 CFR 54, and 21 CFR 56. 
Protocol Version 5.0, 29-Mar-2018 
Page 10 of 84 

Schedule of Assessments 
Visit 1 
Visit2a 
Visit2b 
Visit3 
Visit41 
Visit51 
Visit6 
Visit7 
Visit8 
Visit9 
Visit 
Visit 
Visit 
Visit 
10 
11 
12 
13 
Tooth 
Implant 
6 
Screening 
Implant 
Immediate 
Uncovering 
Definitive 
Final 
month 
Primary 
Follow-
Follow-
Follow-
Follow-
Visit2 
Extraction 
Placement 
Post-Op 
Implant 
Loading 
Impression 
Restoration 
follow-
Endpoint 
Up 
Up 
Up 
Up 
Procedures/ 
Randomization 
Baseline 
uo 
Assessments: 
Immediate 
10 weeks 
10 weeks 
< 45 days 
or 17 
10 days 
± 3 weeks 
± 3 weeks 
5 weeks 
10 weeks 
6 
12 
24 
36 
48 
60 
prior to 
weeks 
post-
post-
post-
post-
post-
months 
months 
months 
months 
months 
months 
implant 
post-
post-
post-
post-
post-
post-
Visit 2a 
post-
placement 
implant 
implant 
loading 
loading 
loading 
loading 
loading 
loading 
loading 
loading 
extraction 
placement 
placement 
Informed consent 
X 
Inclusion/exclusion 
X 
X 
Demographics 
X 
Pregnancy test 
x3 
Med & dental 
X 
history 
Full mouth CBCT or 
panoramic 
X 
radiograph 
Periodontal 
X 
X 
X 
X 
X 
X 
measurements 
Oral hygiene 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
evaluation 
Con. Med. 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Radiographic stent 
X 
Adverse event 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
check 
Tooth Extraction 
X 
Randomization 
X 
Implant placement 
X 
Suture removal 
X 
Uncover implant 
X 
Impression/indexing 
for provisional 
X 
fabrication 
Protocol Version 5.0, 29-Mar-2018 
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Visit 1 
Visit2a 
Visit2b 
Visit3 
Visit41 
Visit51 
Visit6 
Visit7 
Visit8 
Visit9 
Visit 
Visit 
Visit 
Visit 
10 
11 
12 
13 
Tooth 
Implant 
6 
Screening 
Extraction 
Implant 
Immediate 
Uncovering 
Loading 
Definitive 
Final 
month 
Primary 
Follow-
Follow-
Follow-
Follow-
Procedures/ 
Visit2 
Randomization 
Placement 
Post-Op 
Implant 
Baseline 
Impression 
Restoration 
follow-
Endpoint 
Up 
Up 
Up 
Up 
Assessments: 
up 
Immediate 
10 days 
10 weeks 
10 weeks 
6 
12 
24 
< 45 days 
or 17 
± 3 weeks 
± 3 weeks 
5 weeks 
10 weeks 
36 
48 
60 
prior to 
weeks 
post-
post-
post-
post-
post-
months 
months 
months 
months 
months 
months 
Visit 2a 
post-
implant 
implant 
implant 
loading 
loading 
post-
post-
post-
post-
post-
post-
extraction 
placement 
Placement 
Placement 
loading 
loading 
loading 
loading 
loading 
loading 
Temporary 
X 
prosthesis 
Impression for 
X 
definitive fabrication 
Permanent 
X 
prosthesis 
Implant stability -
X 
X 
X 
RFA 
Verbal confirmation 
of pregnancy status, 
X 
X 
X 
X 
X 
X 
X 
if applicable 
Peri-apical 
X 
X 
X 
X 
X 
X 
X 
radiographs 
CBCT - localized 
x4 
X 
X 
X 
X 
X 
X 
Implant survival 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Implant success 
X 
X 
X 
X 
X 
X 
Soft tissue 
X 
X 
X 
X 
X 
X 
evaluation 
Subject satisfaction 
X 
X 
X 
X 
X 
Intra-oral 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
photographs 
1 Uncovering the Implant (Visit 4) and Implant Loading (Visit 5) may be combined at the discretion of the investigator. 
2 The screening assessments can be taken at several visits as long as they are performed within 45 days of the surgery. 
3 The pregnancy test must be administered at screening prior to taking any new radiographs or CBCT scans required for screening. 
4 A localized CBCT is required at screening if a full mouth panoramic radiograph is used at screening instead of the full mouth CBCT. 
Protocol Version 5.0, 29-Mar-2018 
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Table of Contents 
Contact Information .................................................................................................................... 2 
Abbreviations ............................................................................................................................. 5 
Synopsis ..................................................................................................................................... 7 
Schedule of Assessments ........................................................................................................ 11 
Table of Contents ..................................................................................................................... 13 
1 Background and Rationale .................................................................................................. 17 
2 
Study Objectives ................................................................................................................. 18 
3 
Study Design ...................................................................................................................... 19 
3.1 
Type and Design of Study .......................................................................................... 19 
3.2 
Indications for Use ..................................................................................................... 19 
3.3 
Study Treatments ....................................................................................................... 20 
3.4 
Primary Endpoint ....................................................................................................... 21 
3.5 
Secondary Endpoints ................................................................................................. 21 
3.6 
Additional Analysis ..................................................................................................... 22 
3.7 
Study Sample Size ..................................................................................................... 22 
3.8 
Study Duration ........................................................................................................... 22 
3.9 
Study Population ........................................................................................................ 23 
3.9.1 
Inclusion Criteria ............................................................................................. 23 
3.9.2 
Exclusion Criteria ........................................................................................... 24 
4 
Device Description .............................................................................................................. 25 
4.1 
Study Product ............................................................................................................ 25 
4.1.1 
General Description of the Study Implant ....................................................... 25 
4.1.2 
Restorative Components ................................................................................ 26 
4.2 
Instructions for Use, Handling, and Labeling .............................................................. 26 
4.3 
Storage ...................................................................................................................... 27 
4.4 
Device Accountability ................................................................................................. 27 
4.5 
Return of Study Device .............................................................................................. 27 
4.6 
Risk Analysis, Risk/ Benefits ...................................................................................... 28 
5 
Study Procedures ............................................................................................................... 29 
5.1 
Subject Enrollment and Evaluation ............................................................................. 29 
5.1.1 
Informed Consent. .......................................................................................... 29 
5.1.2 
Inclusion and Exclusion Criteria ...................................................................... 30 
5.1.3 
Demographics ................................................................................................ 30 
5.1.4 
Pregnancy Test .............................................................................................. 30 
5.1.5 
Medical and Dental History ............................................................................. 30 
5.1.6 
Screening CBCT or Panoramic Radiograph ................................................... 31 
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5.1.7 
Periodontal Measurements ............................................................................. 31 
5.1.8 
Oral Hygiene Evaluation ................................................................................. 32 
5.1.9 
Concomitant Medication ................................................................................. 32 
5.1.10 Fabrication of Radiographic Stent ................................................................... 32 
5.1.11 Adverse Event Check ..................................................................................... 32 
5.2 
Surgical Procedure and Outcome Assessments ........................................................ 33 
5.2.1 
Surgery/ Tooth Extraction ............................................................................... 33 
5.2.2 
Randomization ............................................................................................... 33 
5.2.3 
Surgery/ Implant Placement ........................................................................... 33 
5.2.4 
Implant Stability by Resonance Frequency Analysis (RFA) ............................ 35 
5.2.5 
Standardized Peri-apical Radiographs ........................................................... 35 
5.2.6 
Marginal Bone Level Changes ........................................................................ 36 
5.2.7 
Buccal Bone Dimensional Changes ................................................................ 36 
5.2.8 
Implant Success and Survival ......................................................................... 36 
5.2.9 
Soft Tissue Evaluation .................................................................................... 37 
5.2.10 Subject Satisfaction ........................................................................................ 38 
5.2.11 Intra-Oral Photographs ................................................................................... 38 
5.3 
Protocol Related Procedures ..................................................................................... 39 
5.3.1 
Screen Failures .............................................................................................. 39 
5.3.2 
Early Withdrawal ............................................................................................ 39 
5.3.3 
End of Study ................................................................................................... 40 
5.3.4 
Subject Replacement Policy ........................................................................... 40 
5.3.5 
Protocol Deviations ........................................................................................ 40 
6 
Schedule of Assessments .................................................................................................. 40 
6.1 
Visit Windows ............................................................................................................ 40 
6.2 
Visit 1 - Screening Visit .............................................................................................. 41 
6.3 
Visit 2a - Tooth Extraction/ Randomization ................................................................ 42 
6.4 
Visit 2b - Implant Surgery .......................................................................................... 42 
6.5 
Visit 3 - Immediate Post-Operative ............................................................................. 43 
6.6 
Visit 4 - Uncovering Implant ....................................................................................... 44 
6.7 
Visit 5 - Implant Loading (BASELINE) ....................................................................... 44 
6.8 
Visit 6 - Definitive Impression .................................................................................... 45 
6.9 
Visit 7 - Final Restoration ........................................................................................... 45 
6.10 Visit 8 - 6 Month Follow-Up ....................................................................................... 46 
6.11 Visit 9 - 12 Month Follow-Up ..................................................................................... 46 
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6.12 Visits 10, 11, 12, and 13 - Follow-Up Visits ................................................................ 47 
7 
Evaluation of Adverse Events ............................................................................................. 48 
7.·1 
Definitions .................................................................................................................. 48 
7 .1.1 
Adverse Event (AE) ........................................................................................ 48 
7 .1.2 
Serious Adverse Event (SAE) ......................................................................... 48 
7.1.3 
Device Deficiency (DD) .................................................................................. 49 
7.1.4 Adverse Device Effect (ADE) .......................................................................... 49 
7.1.5 
Serious Adverse Device Effect (SADE) .......................................................... 49 
7.1.6 
Unanticipated Serious Adverse Device Effect (USADE) ................................. 49 
7.1.7 Anticipated Serious Adverse Device Effect (ASADE) ...................................... 49 
7.2 
Assessment of Adverse Events .................................................................................. 50 
7.2.1 
Seriousness ................................................................................................... 50 
7.2.2 
Relationship to the Study Device .................................................................... 50 
7.2.3 
Relationship to the Procedure ........................................................................ 51 
7.2.4 
Severity .......................................................................................................... 51 
7.2.5 
Outcome ......................................................................................................... 52 
7.2.6 
Expectedness ................................................................................................. 52 
7.3 
Procedure for Reporting Adverse Events ................................................................... 55 
7.3.1 
AE Reporting .................................................................................................. 56 
7.3.2 
SAE Reporting ................................................................................................ 56 
7.3.3 
DD Reporting .................................................................................................. 56 
7.3.4 ADE Reporting ............................................................................................... 56 
7.3.5 
SADE Reporting ............................................................................................. 57 
7.3.6 Additional Safety Reporting ............................................................................ 57 
7.4 
Monitoring of Subjects with Adverse Events ............................................................... 58 
8 
Statistical Analysis Considerations ..................................................................................... 58 
8.1 
Sample Size ............................................................................................................... 58 
8.2 
Randomization ........................................................................................................... 59 
8.3 
Analysis Sets ............................................................................................................. 60 
8.3.1 
Modified Intention to Treat (mlTT) Analysis Set.. ............................................ 60 
8.3.2 
Intention to Treat (ITT) Analysis Set ............................................................... 60 
8.3.3 
Per Protocol (PP) Analysis Set ....................................................................... 60 
8.4 
Effectiveness Analysis Methods ................................................................................. 61 
8.4.1 
Analysis of Primary Endpoint.. ........................................................................ 61 
8.4.2 
Analysis of Secondary Endpoints ................................................................... 61 
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8.4.3 
Analysis of Additional Endpoints ..................................................................... 62 
8.4.4 
Analysis of Safety Endpoints .......................................................................... 62 
8.5 
General Statistical Methods ....................................................................................... 62 
8.5.1 
Balance in Baseline Characteristics ................................................................ 63 
8.5.2 
Surgery and Supporting Procedures ............................................................... 63 
8.5.3 
Other Data Summaries ................................................................................... 63 
8.5.4 
Subject Disposition ......................................................................................... 63 
8.5.5 
Missing Data .................................................................................................. 64 
9 
Data Management .............................................................................................................. 64 
10 Study Management ............................................................................................................ 65 
10.1 Regulatory and Ethical Requirements ........................................................................ 65 
10.1.1 Informed Consent ........................................................................................... 65 
10.1.2 Institutional Review Board .............................................................................. 65 
10.2 Reports and Record Management ............................................................................. 65 
10.2.1 Investigator Records ....................................................................................... 65 
10.2.2 Case Report Forms ........................................................................................ 66 
10.2.3 Source Documents ......................................................................................... 66 
10.2.4 Records/Data Retention ................................................................................. 66 
10.3 Monitoring .................................................................................................................. 67 
10.3.1 Study Initiation Visit ........................................................................................ 67 
10.3.2 Routine Monitoring Visits ................................................................................ 67 
10.3.3 Study Closeout Visit ....................................................................................... 68 
10.4 Study Termination ...................................................................................................... 69 
10.4.1 Center Discontinuation ................................................................................... 69 
10.5 Protocol Amendments ................................................................................................ 69 
10.6 Publications ............................................................................................................... 70 
11 Protocol Signature Page ..................................................................................................... 71 
12 References ......................................................................................................................... 72 
Appendix 1 - Instructions for Use ............................................................................................. 7 4 
Appendix 2 - Declaration of Helsinki ........................................................................................ 78 
Appendix 3 - Visual Analog Scale ............................................................................................ 84 
Protocol Version 5.0, 29-Mar-2018 
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1 
Background and Rationale 
Tapered implants (i.e. which have a smaller diameter at the apical part than the crestal part) 
were introduced primarily to provide better adaptation in immediate extraction sockets. Such 
implants are designed to engage the socket bone at the apical portion and the alveolar socket 
walls at the crestal portion. Hypothetically the benefits of this approach are to reduce, or 
possibly avoid, the need for concomitant bone augmentation procedures and to improve primary 
stability by engaging more of the socket wall than an equivalent cylindrical shaped implant1. 
Studies that assess potential differences between tapered and cylindrical implants are few, but 
the limited data available generally suggests similar survival rates, 2 no significant differences in 
implant stability, 1• 3• 4 and no significant differences in marginal bone loss or bone remodeling 
between the two implant designs. 5• 6• 7 Several studies have documented the extent of bone 
remodeling around tapered implants with immediate and early loading8· 9• 10, 11 and immediate or 
early placement in extraction sockets. 8· 11 ,12 
Straumann® has recently introduced the Bone Level Tapered (BLT) implant to the market. It is a 
solid screw implant comprised of a titanium-zirconium alloy with a SLActive® surface that is 
large-grit sandblasted and acid-etched. In addition, SLActive® is in a chemically activated state, 
which is preserved by storage in a physiological NaCl solution. This implant is suitable for oral 
endosteal implantation in the upper and lower jaw and for the functional and esthetic oral 
rehabilitation of edentulous and partially dentate patients. Straumann® Bone Level Tapered 
implants can be used for immediate or early implantation following extraction or loss of natural 
teeth. 
The goal of implant therapy is to provide support for a functional and esthetic restoration with a 
low risk of complication to the patient. Clinicians have many treatment decisions that impact the 
successful delivery of functional and esthetic restorations, including timing of implant placement 
and type of implant. This study will consider the clinical outcomes of using a Straumann® Bone 
Level Tapered implant for immediate implantation following extraction of natural teeth and 
compare the outcomes to a more conservative approach of placing the implant in a healed site. 
The Proceedings of the Fourth ITI Consensus Conference, sponsored by the International Team 
for lmplantology (ITI), resulted in consensus statements and clinical recommendations focused 
on clinical and esthetic outcomes of implants placed in post extraction sites. Based on this 
summary, benefits of immediate placement in extraction sockets (type 1) include extraction and 
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implant placement in one surgical procedure, reduced overall treatment time, and peri-implant 
defects usually present as a two- or three- walled defect, allowing for simultaneous bone 
augmentation. 13 However, it can be technically difficult to prepare the osteotomy to allow for 
implant placement with primary stability and good prosthetic position. Also, increased risk for 
mucosal recession may compromise esthetic outcomes, hard and soft tissue augmentation 
procedures may increase complexity of the case, and bone modeling following tooth extraction 
can be unpredictable. 13 A recent study found that three months following final crown delivery, 
there were no significant differences in esthetic, clinical and patient-centered outcomes 
following type 1 and type 2 (defined as implant placement after 4-8 weeks of healing) implant 
placement. Short term results suggest that one may achieve good optimal esthetic and clinical 
results with these placement protocols and Straumann titanium Bone Level Implants with the 
SLActive surface 14. 
This randomized, controlled, multi-center study will evaluate the clinical and radiographic 
outcomes of immediate placement of the Straumann® Bone Level Tapered implant in extraction 
sockets and will compare these outcomes to those obtained when placing the implant in healed 
sites. This study will provide data to help guide clinicians when deciding on timing of implant 
placement and how this impacts implant stability and the ability to provide a functional and 
esthetic restoration for the patient. 
2 
Study Objectives 
The aim of this randomized, controlled, multi-center study is to assess the clinical and 
radiographic outcomes of using a Straumann® Bone Level Tapered implant for immediate 
implantation following extraction of a tooth in the pre-molar and anterior region of the maxilla 
and mandible (test) compared to the outcomes of placing this implant in similarly located healed 
sites ( control). All implants will be loaded early at 10 to 12 weeks. 
The primary objective is to demonstrate that the change in mean peri-implant marginal bone 
level changes (mesial and distal) from loading to 12 months post-loading of the test treatment 
will be no worse than the control treatment. 
The secondary objectives of the study are to assess differences in clinical and radiographic 
outcomes between the test and control treatment groups by looking at implant success and 
survival, buccal bone dimensional changes, implant stability, soft tissue changes, subject 
satisfaction and adverse events. 
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An additional objective is to assess long-term differences in clinical and radiographic 
outcomes, as measured in the primary and secondary objectives, over the span of five years. 
3 
Study Design 
3.1 
Type and Design of Study 
This study is a post-market, randomized, controlled, multi-center clinical study. 
3.2 
Indications for Use 
Straumann® dental implants are indicated for oral endosteal implantation in the upper and 
lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially 
dentate patients. Straumann® dental implants can also be used for immediate or early 
implantation following extraction or loss of natural teeth. Implants can be placed with 
immediate function on single-tooth and/or multiple tooth applications when good primary 
stability is achieved and with appropriate occlusal loading, to restore chewing function. The 
prosthetic restorations used are single crowns, bridges and partial or full dentures, which 
are connected to the implants by the corresponding elements (abutments). The complete 
details of the instructions for use for the Straumann® Bone Level Tapered Implant can be 
found in the Instructions for Use IFU (Appendix 1 ). 
Warnings: 
Products must be secured against aspiration when handled intraorally. Aspiration of 
products may lead to infection or unplanned physical injury. 
Avoid approaching the proximity of the mandibular nerve channel during implant bed 
preparation and implant insertion. Nerve damage may result in anesthesia, paresthesia and 
dysthesia. 
Cautions/Precautions: 
Always select the largest diameter implant that can be supported by the available bone 
thickness, bone quality, inter-dental spacing, and anticipated mastication forces. Particular 
care should be taken to assure proper implant alignment when comparatively high loads 
are expected. Small-diameter implants are not recommended for the posterior region. 
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A careful clinical and radiological examination of the patient should be performed prior to 
surgery to determine the psychological and physical status of the patient. Special attention 
should be given to patients who have local or systemic factors that could interfere with the 
healing process of either bone or soft tissue or the osseointegration process (e.g. bone 
metabolism disturbances, previously irradiated bone in the head or neck area, diabetes 
mel/itus, anticoagulation drugs/hemorrhagic diatheses, bruxism, parafunctional habits, 
unfavorable anatomic bone conditions, tobacco abuse, untreated periodontal disease, 
acute infection of implant site, temporomandibular joint disorders, treatable pathologic 
diseases of the jaw and changes in the oral mucosa, pregnancy, inadequate oral hygiene). 
Sterile handling is essential. Never use potentially contaminated components. 
Contamination may lead to infections. 
The implants must be stored in a dry place in the original packaging, protected from direct 
sunlight and at room temperature. Improper storage may compromise essential material 
and design characteristics leading to device failure. 
Do not re-sterilize Straumann dental implants. Cleaning, disinfection and sterilization may 
compromise essential material and design characteristics leading to device failure. 
Do not re-use Straumann Dental implants. Re-use of single-use devices creates a potential 
risk of patient or user infections. 
A void corrections of the vertical position using reverse rotations (counterclockwise). This 
can cause loosening of the screw-retained transfer piece and may lead to decreased 
primary stability. 
3.3 
Study Treatments 
Subjects needing a single tooth extraction and replacement with a dental implant in the 
anterior or pre-molar region of the maxilla or mandible will be screened to determine study 
eligibility. Following tooth extraction, the inclusion and exclusion criteria will be re-
evaluated, and if the subject continues to be eligible, the surgeon will proceed with 
randomization, bone grafting of the extraction socket with Straumann allograft and implant 
placement. Subjects randomized into the test group will receive bone grafting of the 
extraction socket and an implant during the same surgical procedure as the tooth 
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extraction. Subjects randomized into the control group will also undergo bone grafting of 
the extraction socket with Straumann allograft and eturn for a second surgery after 4 
months of healing. 
After randomization the subject is considered enrolled in the study. 
Ten days following implant placement, subjects will be evaluated for healing and possible 
suture removal in cases when non-resorbable sutures are used. The subject will return in 8 
weeks following implant placement to uncover the implant. An index or impression will be 
taken for provisional fabrication. Contingent upon good primary stability, the implant will be 
loaded in appropriate occlusion with an abutment and temporary prosthesis at 10-12 weeks 
post implant placement. Note that implant loading may be done at the same visit as 
uncovering the implant at the discretion of the investigator. 
The definitive impression will be taken at 4-6 weeks following implant loading and the final 
prosthesis will be seated at 8-12 weeks following implant loading. 
3.4 
Primary Endpoint 
Mean crestal bone level change from implant loading to 12 months post-implant loading will 
be measured as the primary endpoint. Crestal bone levels on both the mesial and distal 
aspect of the implant will be averaged to calculate the crestal bone level. 
3.5 
Secondary Endpoints 
The following parameters will be measured as secondary endpoints 12 months post-implant 
loading: 
• 
Implant success and survival 
• 
Buccal bone dimensional changes measured on cone beam computed tomography 
(CBCT) images 
• 
Implant stability measured by resonance frequency analysis (RFA) at implant 
placement, implant loading and final restoration 
• 
Changes in soft tissue (gingival and papilla margins - baseline at final restoration) 
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• 
Subject satisfaction (esthetics, function, and level of pain) 
• 
Adverse Events (AEs) and Adverse Device Effects (ADEs) incidence 
3.6 
Additional Analysis 
An additional analysis will be conducted at 24, 36, 48, and 60 months post-implant loading 
and the following will be measured: 
• 
Mean crestal bone level changes 
• 
Implant success and survival 
• 
Dimensional changes of the buccal bone as measured on CBCT images 
• 
Changes in soft tissue (gingival and papilla margins) 
• 
Subject satisfaction (esthetics, function, and level of pain) 
• 
Adverse events and adverse device effects incidence 
3.7 
Study Sample Size 
The study will enroll and randomize 52 subjects at two research centers. The subjects will 
be randomized 1: 1 to either receive the test treatment or the control treatment. The 
enrollment will be capped at 30 subjects at each site. 
3.8 
Study Duration 
The study is expected to enroll a maximum of 52 subjects over a 12 months period. 
Subjects randomized to the test group will be followed for 63 months (3 months to reach 
implant loading, then 12 months to reach the primary endpoint, followed by another 48 
months of long term follow-up). Subjects randomized to the control group will be followed 
for 67 to 67.5 months (4 to 4.5 months healing prior to implant placement, 3 months to 
reach implant loading, then 12 months to reach the primary endpoint, followed by another 
48 months of long term follow-up. The total duration of the study is expected to span 
anywhere from 79 to 79.5 months. 
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3.9 
Study Population 
The study population will consist of male or female subjects, 18 years of age or older, who 
are in need of a single tooth extraction in the pre-molar or anterior region of the maxilla or 
mandible and who meet the inclusion/ exclusion criteria. Subjects will be recruited through 
the clinics where the investigators are practicing and possibly through referring dentists. 
Subjects are permitted to have multiple teeth extractions and/or receive multiple implants 
during the surgical procedure, however only one of the implants will be defined as the study 
implant. In the case of multiple implants, the study implant site will be selected by the 
investigator prior to implant placement based on which site fits the inclusion/exclusion 
criteria. 
Those subjects who appear eligible according to the inclusion and exclusion criteria will be 
asked to provide informed consent in writing prior to any study related procedures and will 
be considered "consented" in the study. Subjects will be evaluated based on the inclusion 
and exclusion criteria for initial eligibility during the screening visit and re-evaluated after 
tooth extraction. Once the subject is randomized, he/she is considered "enrolled" in the 
study and it will be documented in the enrollment log. Subjects who undergo tooth 
extraction, but are not eligible to be randomized, will be considered screen failures. 
3.9.1 Inclusion Criteria 
All of the criteria must be met to receive the study implant: 
• 
Subjects must have voluntarily signed the informed consent form before any 
study related procedures 
• 
Subjects must be males or females who are a minimum of 18 years of age 
• 
Subjects who are in need of a single tooth extraction in the pre-molar or anterior 
region of the maxilla or mandible (ADA tooth positions 4-13 and 20-29) and 
replacement with a dental implant. 
• 
Implants must be placed either immediately in an extraction socket or placed in 
a healed site (greater than 4 months healing) which has not been previously 
grafted. 
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• 
Planned site for implant must have a natural tooth both mesially and distally in 
the adjacent tooth positions 
• 
Subjects must have opposing dentition (natural teeth, fixed or removable 
restorations) 
• 
There must be sufficient bone at the implant site to achieve primary stability 
based on evaluation of bone from the CT scan and clinical assessment at the 
time of implant 
• 
Subjects must be committed to the study and the required follow-up visits 
• 
Subjects must be in good general health as assessed by the investigator 
3.9.2 Exclusion Criteria 
If any of the following are met prior to receiving the implant, the subject must be 
excluded from the study. 
• 
Subjects with a systemic disease that would preclude dental implant surgery 
• 
Subjects with any contraindications for oral surgical procedures 
• 
Subjects with mucosal diseases (e.g., erosive lichen planus) in the localized 
area around the study implant site 
• 
Subjects with a history of local irradiation therapy in the head/neck area 
• 
Subjects with any untreated endodontic lesions or untreated periodontal 
disease adjacent to the implant site 
• 
Subjects receiving, or having a history of receiving, intravenous or 
subcutaneous antiresorptive agents, such as bisphosphonates 
• 
Subjects with severe bruxing, parafunctional habits, or temporomandibular joint 
dysfunction 
• 
Any implant sites where there will be a buccal dehiscence greater than 3 mm or 
there will be a fenestration of the implant 
• 
Subjects with inadequate oral hygiene or who are unmotivated for adequate 
home care 
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• 
Subjects who have physical or mental handicaps that would interfere with the 
ability to perform adequate oral hygiene 
• 
Subjects who are pregnant or intending to become pregnant during the duration 
of the study 
• 
Subjects who are heavy smokers (defined as >10 cigarettes per day or >1 cigar 
per day) or chew tobacco 
• 
Subjects who abuse alcohol or drugs 
• 
Subjects who have undergone administration of any investigational device 
within 30 days of enrollment in the study 
• 
Subjects with conditions or circumstances, in the opinion of the Investigator, 
which would prevent completion of study participation or interfere with analysis 
of study results, such as history of non-compliance or unreliability 
4 
Device Description 
Specified devices and products to be used in this study will be provided by Straumann USA, 
LLC. 
4.1 
Study Product 
4.1.1 General Description of the Study Implant 
The complete details of the product description and instructions for use for the 
Straumann® Bone Level Tapered implant can be found in the instructions for use 
(Appendix 1 ). The implants are available with an endosteal diameter of 3.3 mm, 4.1 
mm or 4.8 mm and lengths of 8, 10, 12, 14 and 16 mm. They are designed to be 
placed at bone level. They are made of a binary titanium-zirconium alloy called 
Roxolid® and have the SLActive® surface which is a large grit sandblasted and acid-
etched surface in a chemically activated state. The chemically activated state is 
preserved by storage in a physiological sodium chloride solution. 
The following Bone Level Tapered implants will be available for use in this study: 
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Material: 
Surface: 
Diameter: 
3.3mm 
-! 
Length: 
I Arti~le ~umbers:_ 
8mm 
021.3308 
10 mm 
021.3310 
12 mm 
021.3312 
14 mm 
021.3314 
16 mm 
021.3316 
4.1.2 Restorative Components 
Roxolid® 
SLActive® 
4.1 mm 
021.5308 
021.5310 
021.5312 
021.5314 
021.5316 
4.8mm 
021.7308 
021.7310 
021.7312 
021.7314 
021.7316 
The clinician may select the appropriate restorative components for the case from any 
of the Straumann® restorative components available for the Straumann® Bone Level 
Tapered implants. 
4.2 
Instructions for Use, Handling, and Labeling 
Straumann® will provide the two centers with the necessary amount of study products for 
the study. The products delivered for the study are to be used only for the subjects enrolled 
in the study and according to the clinical investigation plan. 
The study product will be used as described in the instructions for use (Appendix 1 - IFU 
701351 ). The implants are CE marked and subject of FDA cleared 510(k) pre-market 
notifications (K140878). The associated prosthetic components for the implant are also CE 
marked and subjects of FDA cleared 510(k) pre-market notifications (K130808, K122192, 
K092814, K093027, K072497, K070549, K110580, K091701, K071357, K062129, 
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K080286, K072071, K081005, K072151, K120822, K132219,). The products must be used 
within their cleared indications. 
All device deficiencies shall be reported by the investigator to Straumann USA on a Device 
Deficiency Case Report Form. 
4.3 
Storage 
The study product should be stored in its original container until used and its access shall 
be controlled. 
After treatment of the last subject, any remaining unopened study products must be 
returned to Straumann® and acknowledged for receipt. The investigator must maintain an 
accurate and up-to-date accountability record of all study products received, used, 
discarded (opened, but non-used) and returned during the course of the study. At each 
monitoring visit, the monitor will check the investigational device accountability for accuracy 
and completeness. 
4.4 
Device Accountability 
The Investigator must maintain an accurate and up-to-date accountability record of all study 
products received, used, discarded (opened, but non-used) and returned during the course 
of the study. This information shall be recorded in the Device Accountability Record Log. 
At each monitoring visit, the monitor will check the investigational device accountability for 
accuracy and completeness. 
At the end of the study, the monitor or Straumann's delegate conducting the closeout visit 
will perform a final reconciliation of the device accountability (cross check between the 
Device Record Accountability Log, the shipments delivery notes and the acknowledgement 
of device receipts). 
4.5 
Return of Study Device 
After treatment of the last subject, any remaining unopened study products at site must be 
returned to Straumann® and acknowledged for receipt. A copy of the acknowledgement of 
receipt must be filed in the Investigator File. 
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4.6 
Risk Analysis, Risk/ Benefits 
The device risk analysis and risk assessment for the Bone Level Tapered implants was 
conducted according to EN ISO 14971 for CE marked implants. Full results are included in 
the Risk Management Report dated 9 May 2014. 
Refer to the Section 7.2.5 of this protocol for a description of the anticipated adverse device 
effects. 
Read carefully the risks associated with the investigational device and the procedures 
involved in its use listed in Instructions for Use in Appendix 1 (IFU 701351) under Warning 
and Cautions/ Precautions. 
There is a residual risk of aspiration/swallowing of the device if the implant is removed once 
it has been seated to 35 Nern (e.g. incorrect implant bed preparation). This reduces the 
retention force of the Loxim transfer piece in the implant and may cause it to fall off once it 
is out of the implant bed. Based on the current information from the field and continuous 
improvement of the design, it is decided that this residual risk is acceptable. Justification: 
the majority of surgeons are using the handpiece to insert a dental implant, at least until the 
last final turns. The reason to remove the implant while inserting it could be due to hard 
bone, under-preparation or too high torque. In this case the implant is removed well before 
the final seating. Removing the implant after it is fully seated is unlikely and seen by the 
surgeons as an exceptional situation, requiring extra attention. Therefore, the risk of 
occurrence of low retention force is outweighed by the benefit of achieving primary stability. 
An anticipated benefit of immediate implant placement with early loading is that extraction 
and implant placement can be performed in one surgical procedure, thereby reducing the 
overall treatment time and possibly allowing simultaneous bone augmentation. 
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5 
Study Procedures 
5.1 
Subject Enrollment and Evaluation 
5.1.1 Informed Consent 
It is the responsibility of the investigator, or a person designated by the investigator (if 
acceptable by local regulations) to obtain informed consent in writing from each subject 
participating in this study prior to any study related procedures. As part of the informed 
consent discussion with a potential subject, the investigator must provide an adequate 
explanation of the overall requirements/procedures of the study, purpose of the study, 
the nature of the planned treatment, any alternative procedures, and possible risks, 
complications, or benefits of the study. The investigator or designee must also explain 
that the subjects are completely free to refuse to enter the study or to withdraw from 
the study at any time for any reason without prejudice. 
The informed consent must be approved by an Institutional Review Board (IRB) before 
consenting can begin. The informed consent form must be available in the primary 
language of the subject. It is written in accordance with the "Declaration of Helsinki" (as 
adopted by the 18th World Medical Assembly, 1964, and as amended in Tokyo (1975), 
Venice (1983), Hong Kong (1989), Somerset West (1996), Edinburgh (2000), 
Washington DC (2002), Tokyo (2004), Seoul (2008), and Fortaleza (2013) (Appendix 
2)) and applicable local regulations. 
This IRB approved consent form must be personally signed and dated by the subject 
and the person obtaining consent. Investigators should keep the original signed 
informed consent document in a secure location. A copy of the signed consent form 
should be given to the subject. The Case Report Forms (CRFs) for this study contain a 
section for documenting informed consent, and this must be completed appropriately. 
If new safety information results in significant changes in the risk/benefit assessment, 
the consent form will be reviewed and updated if necessary. All enrolled subjects 
should be informed of the new information, given a copy of the revised form and give 
their consent to continue the study, unless the subject signed consent and was 
considered a screen failure. 
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5.1.2 Inclusion and Exclusion Criteria 
The inclusion and exclusion criteria will be evaluated according to Sections 3.9.1 and 
3.9.2 at the screening visit. The inclusion and exclusion criteria should be re-evaluated 
at Visit 2a after tooth extraction and prior to randomization. Subjects must fulfill all of 
the inclusion criteria and not meet any of the exclusion criteria to be eligible for 
enrollment in the study. 
5.1.3 Demographics 
Subject demographics, including age, gender, race, and ethnicity, will be documented 
at the screening visit. 
5.1.4 Pregnancy Test 
Women of child-bearing potential (women who are not surgically sterile or 
postmenopausal (defined as amenorrhea for >12 months)) must perform a pregnancy 
test (validated over-the-counter test) at screening, before taking any new radiographs 
or CBCT scans required at screening, to confirm that the woman is not pregnant. The 
test result must be documented in the source data. 
A woman who is pregnant or planning to become pregnant at any point during the 
study duration cannot be enrolled in this study. A woman of child-bearing potential will 
be asked to verbally confirm that she is not pregnant at visits requiring either peri-
apical radiographs or CBCT scans. 
If a woman becomes pregnant during the study, a protocol deviation form should be 
completed. The woman should be followed for the duration of the pregnancy, without 
the study required periapical radiographs or CBCT, and the outcome of the pregnancy 
should be documented. 
5.1.5 Medical and Dental History 
The dental history will be obtained at the screening visit. The dental history should 
include dental status information including a description of the opposing and adjacent 
dentition, history of smoking status, and an oral exam. 
Relevant medical history (e.g., systemic diseases) and current medical conditions will 
be evaluated by the investigator based on the information available. The information 
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may be obtained from the subject's general physician or from oral communication with 
the subject. 
5.1.6 Screening CBCT or Panoramic Radiograph 
A panoramic radiograph or full mouth CBCT scan must be available during screening 
to assess the complete dentition and to use in surgical planning. The screening 
panoramic radiograph or full mouth CBCT scan can be taken during the screening visit 
or be available from a previous date within 6 months of the implant surgery. If a 
panoramic radiograph is used for screening, then a localized CBCT scan is also 
required as a baseline. 
5.1. 7 Periodontal Measurements 
All periodontal measurements will be performed using a manual, millimeter calibrated 
periodontal probe (UNC 15, Hu-Friedy, Chicago, IL, USA). The periodontal 
measurements will be used to assess the periodontal health of the area surrounding 
the dental implant. These measurements will be recorded at screening and at 12, 24, 
36, 48, and 60 months post loading. 
Modified Sulcus Bleeding Index (mSBI): 
It will be documented if bleeding is induced at the marginal gingival tissue by running a 
blunt periodontal probe along the soft tissue wall at the orifice of the pocket. The 
bleeding tendency will be evaluated on the two adjacent teeth at 6 locations 
(distofacial, facial, mesiofacial, distolingual, lingual, mesiolingual) and assessed using 
the mSBI by Mombelli et al. 15 
• 
Score O: No bleeding when a periodontal probe is passed along the gingival 
margin 
• 
Score 1: Isolated bleeding spots visible 
• 
Score 2: Blood forms a confluent red line on margin 
• 
Score 3: Heavy or profuse bleeding 
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Probing Pocket Depth (PPD): 
The PPD will be measured at the two adjacent teeth by recording the distance from the 
gingival margin to the bottom of the probable pocket at six locations (distofacial, facial, 
mesiofacial, distolingual, lingual, mesiolingual). 
5.1.8 Oral Hygiene Evaluation 
The subject's overall oral hygiene will be evaluated at each study visit starting with the 
screening visit by choosing one of the following: "excellent", "good", "fair", or "poor". 
5.1.9 Concomitant Medication 
Concomitant medication, procedures, and supportive therapies will be recorded at the 
screening visit. Any changes in the concomitant medications, procedures, and 
supportive therapies must be documented at each study visit until the end of the study. 
All prophylactic antibiotics and anesthesia given must be recorded on the Concomitant 
Medication Form. This includes the pre-rinse with chlorhexidine mouthwash 0.12% for 
30 seconds immediately prior to the surgery. 
5.1.10 Fabrication of Radiographic Stent 
A radiographic stent will be fabricated at screening. The stent should be fabricated 
according to the instructions provided in the Operations Manual. 
5.1.11 Adverse Event Check 
At each visit the Investigator should determine if any adverse events occurred since 
the last study visit by speaking with the subject and reviewing any dental and medical 
records. These Adverse Events (AEs), along with any adverse events from the current 
study visit, should be documented and reported as descried in Section 7 of the 
protocol. In addition the Investigator should evaluate the status of any ongoing 
adverse events throughout the study as specified in Section 7.4. 
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5.2 
Surgical Procedure and Outcome Assessments 
5.2.1 Surgery/ Tooth Extraction 
Each subject will have a tooth extracted using standard procedures in an outpatient 
environment under local anesthesia and sedation as indicated. Subjects will pre-rinse 
with chlorhexidine mouthwash 0.12% for 30 seconds immediately prior to the surgery. 
5.2.2 Randomization 
All eligible subjects will be randomized at each center in a 1: 1 ratio to one of the two 
treatment groups at the time of surgery. Immediately after tooth extraction and 
confirmation of inclusion and exclusion criteria, the study coordinator or surgical 
assistant will log into the Electronic Data Capturing (EDC) system to determine the 
treatment group assignment. Further treatment will continue based on the 
randomization assignment. 
The treatment group will be assigned to subjects in the chronological order in which 
they were enrolled using a computer generated randomization schedule stratified by 
study center and prepared by an independent randomization statistician. Although this 
study is not blinded, no access to the randomization logic will be available to the study 
center, study subjects, or employees of Straumann. 
In the event that more than one implant can be placed for a subject according to the 
study indication, only one implant will be defined as the study implant and randomized 
to a treatment group. The study implant site will be selected by the Investigator prior to 
surgery, based on an evaluation of which implant site fits the inclusion/exclusion 
criteria. 
5.2.3 Surgery/ Implant Placement 
Each subject will receive the study device using standard implant placement 
procedures which will be performed in an outpatient environment. Surgery is 
performed under local anesthesia and sedation as indicated following standard surgical 
and sterile techniques. For additional information, consult the current Straumann 
procedure guides and Instructions for Use for detailed procedures relating to implant 
bed preparation and implant placement. Prophylactic antibiotic treatment may be given 
at the discretion of the investigator according to the investigator's standard practice. 
Protocol Version 5.0, 29-Mar-2018 
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All prophylactic antibiotics and anesthesia given must be recorded on the Concomitant 
Medication Form. Prior to surgery subjects should have teeth cleaned if required as 
per standard of care at the practice. 
Bone grafting of the extraction socket must be performed on both subjects randomized 
to immediate placement and those randomized to delayed placement. Guided 
Bone/Tissue Regeneration (GBR/GTR) procedures according to the investigator's 
standard practice may also be performed at implant placement for esthetic, contour 
augmentation or to augment minimal buccal dehiscence defects less than 3 mm. The 
size of the defect around the implant must be measured prior to the augmentation 
procedure utilizing a periodontal probe, including defect height, infra-bony defect, 
defect width, and defect depth. For both socket grafting and GBR for contour 
augmentation, only Straumann allograft will be used. 
The following is a detailed list of the procedures and measurements during the implant 
surgery: 
• 
Subjects will pre-rinse with chlorhexidine mouthwash 0.12% for 30 seconds 
immediately prior to the surgery (subjects in control group only). 
• 
For subjects in the immediate placement group, the implant will be placed in the 
same procedure as the tooth extraction. Extract tooth and determine the 
location of the implant site. For subjects in the delayed placement, raise the 
flap. 
• 
Take measurements at the implant site including the orafacial ridge width and 
mesiodistal width at crestal bone level. 
• 
Prepare the implant bed according to the standard drilling sequence and based 
on the bone class. The profile drill and tapping may be recommended. Record 
the bone quality at the implant site (i.e., Type I to Type IV bone). Note the final 
drill and whether it was used to depth. 
• 
Bone grafting of the extraction socket. 
• 
Place the implant into the site according to standard procedures and record the 
implant size and lot number, along with the insertion torque value. Evaluate if 
Protocol Version 5.0, 29-Mar-2018 
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primary stability was achieved and measure the Implant Stability Quotient 
(ISQ). 
• 
Attempt a semi-submerged healing with tissue adapted and sutured over a 
small cover screw. Suture material will be left to the discretion of the 
investigator but documented in the case report form. 
• 
Record if a bone regeneration procedure was necessary for a minimal 
dehiscence less than 3 mm and note the bone substitutes or barriers used in 
the procedure. Also record if soft or hard tissue contour augmentation was 
performed. 
• 
The Investigator may prescribe Chlorhexidine rinse in addition to medications 
for infection control and post-operative pain control according to his/her 
standard practice. Instructions on proper post-operative oral hygiene, routine 
cleaning and maintenance should be provided as required by standard of care. 
5.2.4 Implant Stability by Resonance Frequency Analysis (RFA) 
An Osstell device is an instrument that uses the RFA method to determine implant 
stability and osseointegration. The result is presented as an Implant Stability Quotient 
(ISQ) value of 1 - 100. The higher the ISQ, the more stable the implant. Additional 
information about the Osstell device can be found at www.osstell.com. Instructions on 
taking the measurements for this protocol will be provided in the Operation Manual. In 
general two measurements will be taken from two different angles at implant 
placement, implant loading, and final restoration. 
5.2.5 Standardized Peri-apical Radiographs 
Standardized peri-apical radiographs of the area being treated will be taken post-
operatively, at implant loading, and at 12, 24, 36, 48, and 60 months post-loading. The 
radiographs must be of high quality and definition, so as to identify the bone contours 
in question. Ideally the entire implant should be visible on the radiograph. However it 
is not essential that the apical end of the implant is on the radiograph; in this case at 
least three threads must be visible on the radiograph. These radiographs will be used 
for crestal bone level assessment and evaluation of implant success. 
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Radiographs will be digital, using either a direct sensor system or an indirect system 
with Photostimulable Phosphor (PSP) plate. A stent is to be used. All settings must be 
noted and utilized on subsequent visits. 
To standardize the series of periapical radiographs, the same sensor/phosphor plate 
holder and beam aiming device will be used throughout the study (e.g., Rinn System). 
The radiographs will be taken with the sensor/phosphor plate placed parallel to the 
implants and the X-ray beam directed perpendicular to the implants. The digital image 
should be saved as a JPEG file and the file name should be formatted as follows: 
Subject number (XX-XX)_Subject initials (XXX)_lmage date (DD MMM YYYY), i.e., 01-
01_ABC_04 Nov 2014.jpg 
The files will be uploaded into the Electronic Data Capture system. 
5.2.6 Marginal Bone Level Changes 
Bone level changes will be evaluated on a standardized peri-apical radiograph at 
implant loading and at 12, 24, 36, 48, and 60 months post-loading. The radiographs 
will be sent to a centralized location to be evaluated in a blinded fashion by a single 
reader using a calibrated measuring tool. Additional details will be provided in 
operations manual to describe how the central radiologist will measure the bone level 
values from the radiographs. 
5.2.7 Buccal Bone Dimensional Changes 
Cone beam computed tomography will be utilized to measure the dimensional 
thickness of buccal plate of the localized area around the implant at screening, implant 
loading and at 12, 24, 36, 48 and 60 months post-loading. Additional details will be 
provided in operations manual to describe how the central radiologist will measure the 
bone level values from the CBCT scans. 
5.2.8 Implant Success and Survival 
Implant survival will be assessed at all visits following the surgical visit. A surviving 
implant is an implant that is in place at the time of follow-up. 
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Implant success will be assessed at implant loading, and at 12, 24, 36, 48, and 60 
months post loading. A successful implant will meet all of the following criteria 
according to Buser16: 
• 
Absence of persistent subjective complaints, such as pain, foreign body 
sensation, and/ or dysesthesia 
• 
Absence of a recurrent peri-implant infection with suppuration 
• 
Absence of mobility 
• 
Absence of a continuous radiolucency around the implant 
Non-surviving implants will be counted as an unsuccessful implant. 
Any dental implant showing excessive bone loss, radiolucency, or infection shall be 
treated in the manner best suited to the well-being of the subject, including treatment to 
save the dental implant. Continuous radiolucency, implant mobility, and recurrent peri-
implant infection with suppuration shall be recorded on the adverse event form (see 
section 7.3.4). 
5.2.9 Soft Tissue Evaluation 
Gingival recession and papilla height will be evaluated according to Grunder17, 
recording changes in gingiva/mucosa and papilla margins over time. The soft tissue will 
be evaluated at final restoration, and at 12, 24, 36, 48, 60 months post-implant loading. 
The following measurements will be recorded in millimeters: 
• 
Measurement CL Tm and CL Td - length of the crown from highest point of soft 
tissue margin to the incisal edge of the adjacent mesial and distal teeth 
• 
Measurement CU - length of the implant crown from highest point of the soft 
tissue margin to the incisal edge 
• 
Measurement I Pm and I Pd - distance from the top of the papilla to the incisal 
edge mesial and distal of the implant crown 
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5.2.10 
Subject Satisfaction 
Subject satisfaction will be assessed utilizing Visual Analogs Scales (VAS) at 12, 24, 
36, 48, and 60 months post implant loading for the following parameters related to the 
implant and restoration: 
• 
Level of pain associated with the implant and crown -
Painful ➔ No pain 
• 
Level of satisfaction with the function of the implant supported crown - Not 
satisfied at all ➔ Highly satisfied 
• 
Level of satisfaction with the esthetics of the implant supported crown - Not 
satisfied at all ➔ Highly satisfied 
Each subject will be asked to complete a VAS for each of the above parameters by the 
Investigator. The subject will be given a paper questionnaire to mark their responses 
on the VAS (Appendix 3). The subject will mark a 100 mm scale with a vertical line. A 
measurement will be made from the left on the scale to the point of the first marking 
from the subject. This measurement will be recorded on a case report form. 
5.2.11 
Intra-Oral Photographs 
Intra-oral photographs will be taken at each study visit to show the pre-operative 
situation, the implant in place in the bone at surgery, the temporary restoration, the 
final restoration and the final crown at all follow-up visits. Additional photographs are 
optional and can be taken to fully document the case. 
Each photograph should be labeled with the subject's study identification number and 
visit date. 
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5.3 
Protocol Related Procedures 
5.3.1 Screen Failures 
Any subject that signs the Informed Consent Form must be entered into the electronic 
database. Subjects will be evaluated based on the inclusion and exclusion criteria for 
initial eligibility during the screening visit and re-evaluated after tooth extraction. Any 
subjects that are determined to be ineligible prior to be randomized, will be considered 
screen failures. Screen failures will be documented by completing a Screen Failure 
Case Report Form. 
5.3.2 Early Withdrawal 
Any subject may withdraw from the study at any time without prejudice and will be 
offered an alternative treatment for his/her dental condition. Subjects will be advised of 
the need for the prescribed follow-up visits for their ongoing care, well-being, and 
collection of any safety data. 
The Investigator may withdraw any subject from the study in the case of: 
• 
Non-compliance with the protocol 
• 
Failure to attend the follow-up visits 
• 
Serious Adverse Event (SAE) or adverse event, which in the opinion of the 
Investigator prevents the subject's further participation in the study. 
• 
Failure to achieve primary stability - if primary stability is not obtained and the 
implant is removed, the patient will be withdrawn at the time of implant removal. 
No further follow up is necessary. 
• 
No study implant placed - if the study implant is never placed, regardless of 
reason, the patient will be withdrawn. No further follow up is necessary. 
The subject withdrawal will be documented on a Study Termination/ End of Study CRF 
and must include the reason for the subject withdrawal. Efforts should be made to 
capture the primary study endpoint for each subject prior to withdrawal, if possible. If 
the subject fails to attend follow-up visits, at least three attempts to reach the subject 
must be documented; with at least one of the attempts made by certified letter. 
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Withdrawn subjects will not be replaced. 
5.3.3 End of Study 
Once the subject is seen for the final visit at 60-months post-loading, the subject will 
have completed the study. This will be documented on a Study Termination/ End of 
Study CRF. 
5.3.4 Subject Replacement Policy 
Subjects who have been randomized will not be replaced. 
5.3.5 Protocol Deviations 
Deviations from the procedures established in the protocol are not permitted. If a 
deviation occurs, the study center must record the deviation on the appropriate CRF. 
The sponsor shall be notified immediately of any deviations in informed consent, 
inclusion/exclusion criteria, and randomization procedures. The IRB should be notified 
according to the requirements of the local IRB. 
Any deviation from the protocol (including deviations from the expected study visit 
windows) may jeopardize the study outcome. Non-compliance of the subjects, as well 
as of the Investigators, may lead to the closure of the respective study center. 
6 
Schedule of Assessments 
An overview of the schedule of assessments is provided in a table format after the protocol 
synopsis. 
6.1 
Visit Windows 
Subjects need to be seen within the following windows: 
Visit# 
Visit Name 
Visit Window 
Visit 1 
Screening 
< 45 days from tooth extraction 
Visit 2a 
Tooth Extraction and Randomization 
Bone grafting of the extraction socket 
Immediately at tooth extraction 
Visit 2b 
Implant Surgery 
or 
17 weeks ± 1 weeks after tooth extraction 
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Visit 3 
Immediate Post-Operative 
10 days ± 3 days after implant surgery 
Visit 4* 
Uncover Implant 
10 weeks ± 3 weeks after implant surgery 
Visit 5* 
Implant Loading/ Temporary Restoration 10 weeks ± 3 weeks after implant surgery 
Visit 6 
Impression 
5 weeks ± 1 week post-loading 
Visit 7 
Final Restoration 
10 weeks ± 2 week post-loading 
Visit 8 
6-month follow-up 
6 months ± 1 month post-loading 
Visit 9 
Primary Endpoint 
12 months ± 1 month post-loading 
Visit 10 
Additional follow-up 
24 months ± 1 month post-loading 
Visit 11 
Additional follow-up 
36 months ± 1 month post-loading 
Visit 12 
Additional follow-up 
48 months ± 1 month post-loading 
Visit 13 
Additional follow-up 
60 months ± 1 month post-loading 
*Note: Uncovering the implant and implant loading may be done at the same visit at the discretion of the investigator. 
6.2 
Visit 1 - Screening Visit 
This visit should be completed within 45 days prior to the tooth extraction (Visit 2a). An 
initial evaluation will be conducted to determine whether the subject meets the study 
inclusion and exclusion criteria and for collection of baseline data. This evaluation will 
include an appropriate medical and dental history, a clinical examination, and a 
radiographic evaluation. The screening evaluations and data collection can take place at 
several office visits as long as the visits are within 45 days of the surgery. 
If the screening evaluations are not conducted within 45 days of the surgery, then the 
subject may be asked to re-consent and re-screen, as long as enrollment is still open. 
In particular the following procedures and assessments will be performed and recorded at 
the screening visit: 
• 
Informed consent 
• 
Inclusion/exclusion criteria 
• 
Demographics 
• 
Pregnancy test (administered prior to randomization and before taking study 
required radiographs or CBCT scans) 
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• 
Medical and dental history 
• 
Full mouth CBCT or panoramic radiograph with a localized CBCT scan 
• 
Periodontal measurements (PPD and mSBI at adjacent teeth) 
• 
Oral hygiene evaluation 
• 
Concomitant medications 
• 
Adverse event check 
• 
Radiographic stent fabrication 
• 
Intra-oral photographs 
6.3 
Visit 2a - Tooth Extraction/ Randomization 
The following will be performed at this visit: 
• 
Review inclusion/exclusion criteria 
• 
Oral hygiene evaluation 
• 
Concomitant medication 
• 
Adverse event check 
• 
Surgery/ tooth extraction 
• 
Bone grafting of the extraction socket 
• 
Randomization 
• 
Intra-oral photographs 
6.4 Visit 2b - Implant Surgery 
The timing of Visit 2b will depend on the treatment group assigned during randomization. 
For subjects randomized to the test group, the implant will be placed immediately after tooth 
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extraction and bone grafting of the extraction socket. For subjects randomized to the 
control group, the extraction socket will be bone grafted but allowed to heal for at least 4 
months. Straumann allograft will be used for all socket grafting. The subject should return 
for Visit 2b implant surgery, at 17 weeks (± 1 week). 
• 
Review inclusion/exclusion criteria 
• 
Oral hygiene evaluation 
• 
Concomitant medication 
• 
Adverse event check 
• 
Surgery/ bone grafting of extraction socket/implant placement 
• 
Implant stability by RFA 
• 
Verbal confirmation of pregnancy status, if applicable 
• 
Standardized periapical radiographs 
• 
Intra-oral photographs 
6.5 
Visit 3 - Immediate Post-Operative 
The subject will be recalled for a post-operative visit at 10 days (± 3 days) following implant 
placement for a general assessment of wound healing and to remove sutures, if applicable. 
In particular, the subject will have the following procedures and/or evaluations performed 
and documented: 
• 
Suture removal, if necessary 
• 
Oral hygiene assessment 
• 
Concomitant medication 
• 
Adverse event check 
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• 
Implant survival 
• 
Intra-oral photographs 
6.6 
Visit 4 - Uncovering Implant 
At 10 weeks(± 3 weeks) following implant surgery, the implant will be uncovered, a healing 
abutment placed, and the soft tissue adapted around the healing abutment. Note that 
implant loading (Visit 5) may be done at Visit 4 at the discretion of the investigator. 
• 
Uncover implant, place healing abutment 
• 
Impression or indexing the implant for indirect provisional fabrication 
• 
Oral hygiene assessment 
• 
Concomitant medication 
• 
Adverse event check 
• 
Implant survival 
• 
Intra-oral photographs 
6. 7 Visit 5 - Implant Loading (BASELINE) 
At 10 weeks (± 3 weeks) after implant surgery (2 - 4 weeks after uncovering the implant), 
and contingent upon good primary stability, the study implant will be loaded with a 
temporary abutment and restoration in appropriate occlusion. Note that uncovering of the 
implant (Visit 4) and implant loading can be done at the same visit at the discretion of the 
investigator. 
The subject will have the following procedures and/or evaluations performed and 
documented: 
• 
Temporary prosthesis seated 
• 
Oral hygiene evaluation 
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• 
Concomitant mediation 
• 
Adverse event check 
• 
Implant stability by RFA 
• 
Verbal confirmation of pregnancy status, if applicable 
• 
Standardized periapical radiographs 
• 
CBCT - localized 
• 
Implant survival and success 
• 
Intra-oral photographs 
6.8 
Visit 6 - Definitive Impression 
At 5 weeks(± 1 week) post loading, an impression (digital or conventional) will be taken for 
the fabrication of the final restoration. 
The subject will have the following procedures and/or evaluations performed and 
documented: 
• 
Impression for definitive fabrication 
• 
Oral hygiene evaluation 
• 
Concomitant mediation 
• 
Adverse event check 
• 
Implant survival 
• 
Intra-oral photographs 
6.9 
Visit 7 - Final Restoration 
Subjects will be recalled at 10 weeks (± 2 weeks) post loading to seat the final restoration. 
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The subject will have the following procedures and/or evaluations performed and 
documented: 
• 
Permanent prosthesis seated 
• 
Oral hygiene evaluation 
• 
Concomitant medication 
• 
Adverse event check 
• 
Implant stability by RFA 
• 
Implant survival 
• 
Soft tissue evaluation 
• 
Intra-oral photographs 
6.10 Visit 8 - 6 Month Follow-Up 
Subjects will be recalled at 6 months (± 1 month) for brief evaluation of the implant 
supported final restoration and check possible adverse events. 
• 
Oral hygiene evaluation 
• 
Concomitant medication 
• 
Adverse event check 
• 
Implant survival 
• 
Intra-oral photographs 
6.11 Visit 9 - 12 Month Follow-Up 
Subjects will be recalled at 12 months (± 1 month). Primary and secondary endpoints will 
be evaluated at this visit. 
• 
Periodontal measurements (PPD and mSBI at adjacent teeth) 
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• 
Oral hygiene evaluation 
• 
Concomitant mediation 
• 
Adverse event check 
• 
Verbal confirmation of pregnancy status, if applicable 
• 
Standardized periapical radiograph 
• 
CBCT- localized 
• 
Implant survival and success 
• 
Soft tissue evaluation (gingival margin and papilla height) 
• 
Subject satisfaction 
• 
Intra-oral photographs 
6.12 Visits 10, 11, 12, and 13 - Follow-Up Visits 
Subjects will be recalled at 24 months (± 1 month), 36 months (± 1 month), 48 months (± 1 
month), and 60 months (± 1 month) post loading. Data from these visits will be used for the 
additional analyses. 
• 
Periodontal measurements (PPD and mSBI at adjacent teeth) 
• 
Oral hygiene evaluation 
• 
Concomitant mediation 
• 
Adverse event check 
• 
Verbal confirmation of pregnancy status, if applicable 
• 
Standardized periapical radiograph 
• 
CBCT - localized 
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• 
Implant survival and success 
• 
Soft tissue evaluation (gingival margin and papilla height) 
• 
Subject satisfaction 
• 
Intra-oral photographs 
7 
Evaluation of Adverse Events 
For the avoidance of doubt, a// AE/SAEs as defined below, regardless of whether they are 
related to the investigational device, should be collected, fully investigated and documented 
in the source document and appropriate case report form for all subjects from the time of the 
signing of the informed consent until the last protocol-specific procedure. Documentation 
includes dates of event, treatment, outcome, assessment of seriousness and causal relationship 
to the device and/or study procedure (rationale to be provided). 
7.1 
Definitions 
7 .1.1 Adverse Event (AE) 
An AE is defined as any untoward medical occurrence, unintended disease or injury, or 
any untoward clinical signs (including abnormal laboratory findings) in subjects, users 
or other persons, whether or not related to the investigational medical device. This 
definition includes events related to the investigational medical device or the 
comparator, or events related to the procedures involved. For users or other persons, 
this definition is restricted to events related to investigational medical devices. 
7.1.2 Serious Adverse Event (SAE) 
Any adverse event that: 
• 
led to a death 
• 
led to a serious deterioration in the health of the subject, that either resulted in 
o 
a life-threatening illness or injury, or 
o 
a permanent impairment of a body structure or a body function, or 
o 
in-patient or prolonged hospitalization, or 
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o 
medical or surgical intervention to prevent life-threatening illness or 
injury or permanent impairment to a body structure or a body function, 
• 
led to fetal distress, fetal death, or a congenital abnormality or birth defect 
NOTE: A planned hospitalization for a pre-existing condition, or a procedure required 
by the protocol, without serious deterioration in health, is not considered to be a 
serious adverse event. 
7 .1.3 Device Deficiency (DD) 
A device deficiency is an inadequacy of a medical device with respect to its identity, 
quality, durability, reliability, safety or performance. ODs include malfunctions, use 
errors and inadequate labeling. 
7 .1.4 Adverse Device Effect (ADE) 
An ADE is an adverse event related to the use of an investigational medical device. 
This definition includes adverse events resulting from insufficient or inadequate 
instructions for use, deployment, implantation, installation, or operation, or any 
malfunction of the investigational medical device. This definition includes any event 
resulting from use error or from intentional misuse of the investigational medical 
device. Any adverse event which the clinical investigator believes has even a 
possible relationship to the device will be classified as an ADE. 
7 .1.5 Serious Adverse Device Effect (SADE) 
An SADE is an adverse device effect that has resulted in any of the consequences 
characteristic of a serious adverse event. 
7 .1.6 Unanticipated Serious Adverse Device Effect (USADE) 
An USADE is a serious adverse device effect which by its nature, incidence, severity or 
outcome has not been identified in the current version of the risk analysis report. 
7 .1. 7 Anticipated Serious Adverse Device Effect (ASADE) 
An ASADE is a serious adverse device effect which by its nature, incidence, severity or 
outcome has been identified in the risk analysis report. 
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Summary_ of the classification for adverse events: 
Adverse 
Qeyipe .. o.r .. ~r~¢JctJrt:ritii~j;, 
"S'/"J[>:< ·::, 
--
,,,,.,,, 
, 
Adverse Device Effect (ADE) 
Serious Adverse Device Effect (SADE) 
Anticipated 
Unanticipated 
Serious Adverse Event 
(SAE) 
Anticipated Serious 
Unanticipated Serious 
Adverse Device Effect 
Adverse Device Effect 
(ASADE) 
(USADE) 
7 .2 
Assessment of Adverse Events 
In the event of an adverse event, the investigator or another suitably qualified clinician who 
is trained in recording and reporting AEs and have been delegated to this role (such 
delegation must be captured in the study site delegation log) must review all documentation 
(e.g., hospital notes, laboratory and diagnostic reports) relevant to the event. 
Each adverse event should be assessed for seriousness, relationship to the study device or 
the procedure, severity, outcome, and expectedness, as described below, by the 
Investigator. 
7 .2.1 Seriousness 
An adverse event will be described as serious if it meets the definition in Section 7 .1.2. 
The rationale for the assessment shall be provided in a short narrative. 
7.2.2 Relationship to the Study Device 
The investigator should assess the relationship of the adverse event to the implanted 
product (e.g., dental implant) and provide the rationale in a short narrative. The 
relationship should be assessed using the following categories: 
• 
Definitely related - There is a reasonable causal and temporal relationship 
between the treatment with the study device and the adverse event. 
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• 
Possibly related - The causal and temporal relationship between the 
treatment with the study device and the adverse event is less likely; however, 
the determination that there is no relationship cannot be made. 
• 
Not related - A causal relationship with device application can be definitely 
excluded. By definition, all AEs/ADEs, with a start date before the surgery 
procedure at Visit 2 must be assigned a "not related" relationship with study 
device. 
NOTE: Device deficiencies that might have led to an SAE are always related to the 
medical device. 
7 .2.3 Relationship to the Procedure 
The investigator should assess the relationship of the adverse event to the implant 
procedure (e.g. placement of dental implant) and provide the rationale in a short 
narrative. The relationship should be assessed using the categories described in 
Section 7.2.2. 
7 .2.4 Severity 
Each adverse event should be assessed by the investigator for its severity, or the 
intensity of an event experienced by a subject, using the following: 
• 
Mild - discomfort noticed, but no disruption in daily activities; the event is easily 
tolerated by the subject 
• 
Moderate - discomfort sufficient enough to reduce or affect normal daily 
activity 
• 
Severe - Inability to work or perform normal daily activity and/or the subject's 
life is at risk from the adverse event 
The maximum severity observed is to be recorded, except if there is a significant 
worsening in an AE/ADE severity after device intake, then the change will be tracked 
as a new AE/ADE record as follows: 
• 
The same wording describing the original AE/ADE must be used. 
• 
Outcome of the initial entry should be designated as 'worsened'. 
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• 
The end date of the previous AE/ADE must equal the start date of the new 
AE/ADE. 
7 .2.5 Outcome 
The outcome should reflect the status of the adverse event at the moment of recording. 
• 
Resolved - The subject fully recovered from the event without any sequelae. 
This option also applies when it is unknown whether there are sequelae. 
• 
Resolved with sequelae - The subject's condition stabilized despite the 
persistence of sequelae (e.g., lesion or medical condition which is a 
consequence of the event). This option does not apply to irreversible 
congenital anomalies (see under "ongoing"). 
• 
Ongoing - The subject has not yet recovered from the event. By convention, 
in the case of an irreversible congenital anomaly, the "Ongoing" option should 
be chosen and understood as "Not recovered/Not resolved". The same applies 
to conditions that are not yet resolved, but are controlled by medication (e.g., 
diabetes, epilepsy) and therefore may not have any symptoms. 
• 
Worsened - The severity of the AE/ADE increased. 
• 
Fatal - The event is related to a death; whether it caused death or contributed 
to it. If the subject died of a different cause, prior to resolution of the AE/ADE, 
the outcome of this AE/ADE should designated "Ongoing", and not "Fatal", and 
an end date should not be specified. 
• 
Unknown: Knowledge of the current status of the AE/ADE is truly not available 
to the investigator (i.e. event was ongoing at last observation, but no further 
contact with the subject could be established). However, all efforts should be 
made to determine the outcome of any AE, especially that of an SAE/SADE. 
7.2.6 Expectedness 
If the adverse event is judged to be related to the device, the investigator will make an 
assessment of expectedness based on knowledge of the reaction and any relevant 
product information as documented in the IFU and current protocol. The event will be 
classed as either; 
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• 
Expected: the reaction is consistent with the effects of the device listed in the 
IFU and protocol; 
• 
Unexpected: the reaction is not consistent with the effects listed in the IFU and 
protocol. 
The table below presents the potential expected adverse device effects following the 
insertion of dental implants. 
Table: List of expected ADEs following the insertion of dental implants: 
Nature of effect 
I Severity 
Frequency 
(very rare, rare, 
(mild, moderate, severe) 
probable, frequent) 
• 
Peri-implant mucositis 
Bleeding (BOP Bleeding On Probing) 
mild 
probable 
Bruising 
mild 
frequent 
Delayed healing of the gum 
mild 
rare 
Inflammatory papillary hyperplasia 
mild 
probable 
Gingival/mucosal hyperplasia 
mild 
probable 
Pain 
mild to moderate 
probable 
Recession/dehiscence of the gum 
moderate 
rare 
Redness 
mild 
probable 
--
Suppuration 
moderate 
probable 
Swelling/gingival inflammation 
mild 
probable 
-
• 
Peri-implantitis 
Bleeding (BOP Bleeding On Probing) 
mild 
probable 
Bone loss around implant 
moderate 
probable 
Bruising 
mild 
frequent 
Infection at implant site without suppuration (not 
I mild to moderate 
I probable 
recurrent) 
Infection at implant site with suppuration (not recurrent) 
I moderate 
I rare 
Recurrent infection at implant site without suppuration 
I moderate to severe 
I rare 
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Recurrent infection at implant site with suppuration 
moderate to severe 
rare 
Systemic infection 
severe 
very rare 
Pain 
mild to moderate 
probable 
--· 
Swelling 
mild 
probable 
• 
Bone integration deficiency 
Early loss/exfoliation (within 2 weeks after surgery) 
moderate 
probable 
Late loss/exfoliation (after prosthetic restoration) 
moderate 
probable 
No primary stability (at surgery) 
moderate 
rare to probable 
Implant mobility (tactile horizontal or vertical) 
moderate 
rare to probable 
Radiolucency 
mild to moderate 
probable 
Aspiration of implant 
severe 
very rare 
Swallowing of implant 
severe 
very rare 
• 
Non-plaque related 
Chronic pain in connection with the dental implant 
mild to moderate 
rare 
Foreign body sensation 
mild 
probable 
Material allergy 
moderate 
rare 
Oro-sinus or oro-nasal intrusion/fistula 
severe 
very rare 
Permanent paresthesia, dysesthesia 
severe 
rare 
Temporary or permanent nerve damage in the jaw 
severe 
very rare 
Mechanical complications 
.· 
Nature of effect 
Severity 
Frequency 
(mild, moderate, severe) 
(very rare, rare, 
probable, frequent) 
Loosening of abutment screw 
mild 
probable 
Loosening of an healing cap 
mild 
probable 
Loosening of prosthetic screw 
mild 
probable 
Lost/failure of an abutment 
moderate 
probable 
Lost/failure of an healing cap 
mild 
probable 
Fracture of abutment screw 
moderate 
probable 
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Fracture of 
Fracture of 
Nature of 
Failure of prosthesis (framework, opposing framework) I moderate 
Fracture of prosthesis 
mild to moderate 
probable 
Fracture of veneering material 
mild 
probable 
Irreversible damage to adjacent/opposing teeth 
moderate 
rare 
Loss of cement retention of prosthesis 
I mild 
I probable 
Nature of effect 
Aesthetic problem 
mild 
rare 
Aspiration of component(s) (other than implant) 
severe 
very rare 
Jaw, bone fracture 
moderate to severe 
very rare 
Phonetic difficulties 
mild to moderate 
rare 
Swallowing of component(s) (other than implant) 
severe 
very rare 
Hypersensitivity (adjacent teeth) 
mild 
probable 
7.3 
Procedure for Reporting Adverse Events 
Adverse event reporting will begin at the time a subject provides written informed consent 
and ends after a subject withdraws from the study or completes the final study visit. 
For screen failure subjects, any AEs, ADEs, and ODs that occur from the time of informed 
consent up until the date on which the subject is deemed ineligible for the study will be 
recorded on a case report form. 
Only one AE/SAE case report form should be completed per event. 
To ensure patient confidentiality, the following reports will include the patient number only. 
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7.3.1 AE Reporting 
In the occurrence of an AE, data should be entered into the AE case report form in the 
EDC system within five working days of awareness of the event. Safety reporting to 
the IRB should occur according to the requirements of the local IRB. 
7.3.2 SAE Reporting 
In the occurrence of a serious adverse event (SAE), expedited reporting requirements 
are followed. The SAE case report form should be completed in the EDC within 24 
hours of awareness of the event. Straumann will receive an automated notification 
generated by the EDC system. 
Safety reporting to the IRB should occur according to the requirements of the local IRB. 
It is recognized that in many cases SAEs will be treated in a medical rather than a 
dental environment and the investigator may not have immediate knowledge of the 
event. The investigator should report an SAE as soon as he/she has knowledge of the 
event within the above time frame irrespective of when the actual event occurred. 
7.3.3 DD Reporting 
The Investigator should report all device deficiencies by completing the Device 
Deficiency CRF. 
When a device deficiency leads to a potential AE (e.g. bleeding, pain, swelling, 
infection, peri-implantitis) the AE case report form in the database needs to be 
completed in a timely manner. 
Moreover, device deficiencies with SADE potential (e.g. nerve encroachment, sinus 
perforation, etc.) must be recorded in the SAE case report form and follow the 
expedited reporting requirements (within 24 hours). 
7.3.4 ADE Reporting 
Adverse device effects must be recorded and submitted to Straumann by completing 
the AE case report form in the EDC system within five working days of awareness of 
the event. Safety reporting to the Institutional Review Board (IRB) should occur 
according to the requirements of the local IRB. 
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Bone loss reporting: Continuous substantial reduction of the peri-implant bone level is 
a sign of failure of the implant system. The first European Workshop on 
Periodontology specified an average marginal bone loss of less than 1.5 mm bone loss 
within the first year after the insertion of the prosthesis, and thereafter less than 0.2 
mm annual bone loss as criteria for measuring success18. This has been a standard 
and a basis for success criteria since it was defined in 1993. In a more recent meta-
analysis, the authors looked at Straumann implants and determined that a pooled 
weighted mean of marginal bone level change for Straumann implants was -0.56 mm 
(95% Cl -0.661, -.481) after 5 years. The individual study means of marginal bone 
level change ranged from -0.15 to -1.0 mm after 5 years. 19 Based on this information 
the central radiologist will flag any bone level changes that are greater than 2.5 mm in 
the first year post-loading and any annual changes greater than 1.5 mm in subsequent 
years. The study manager will review the flagged values and discuss with the principal 
investigator whether the bone level change will be reported as an ADE. 
7 .3.5 SADE Reporting 
In the occurrence of a serious adverse device effect, expedited reporting requirements 
are followed. The SAE case report form should be completed within 24 hours of 
awareness of the event in the EDC system. Straumann will receive an automated 
notification generated by the EDC system. 
The product safety officer at Straumann will work with the Investigator to determine 
whether the event is anticipated (ASADE) or unanticipated (USADE). In case of 
USADE, the investigator must promptly notify its reviewing IRB as soon as possible, 
but no later than ten (10) working days after first learning of the event. 
Since this is a multi-center study, Straumann will inform investigators at all participating 
centers of any reported USADEs related to this protocol and the study device. Copies 
of such external USADE reports should be forwarded to the IRB for review and a copy 
must be kept in the investigator site files. 
7 .3.6 Additional Safety Reporting 
Straumann will report additional safety information to the centers that is relevant to the 
protocol or study device and may affect the risk/benefit ratio, the rights, safety or 
welfare of subjects, or the integrity of the study. Such reports may include notification 
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of any changes to the instructions for use, any publications or interim reports, or any 
product recalls. 
7.4 Monitoring of Subjects with Adverse Events 
Any AE that occurs during the course of this study must be monitored and followed-up by 
the investigator until one or more of the following have occurred: 
• 
The AE is resolved, 
• 
Pathological laboratory findings have returned to normal, 
• 
Steady state has been achieved, or 
• 
It has been shown to be unrelated to the study products. 
The outcome of an event will be pursued until resolution or until the last data queries are 
issued following the subject's last study visit. For screen failure subjects, ongoing AEs, 
ADEs, and ODs must be followed and updated until the date the subject is deemed a 
screen failure. For subjects documented as lost to follow-up, ongoing AEs, ADEs, and ODs 
will not be followed. 
It is the responsibility of the sponsor to cooperate with the investigator to assure that any 
necessary additional therapeutic measures and follow-up procedures are performed. 
8 
Statistical Analysis Considerations 
8.1 
Sample Size 
The following assumptions were used to determine the sample size for the primary endpoint 
of mean change in crestal bone level between implant placement and 12 months post-
implant loading: 
• 
Subjects will be assigned to either the test or control treatment group 
• 
The primary analysis is a non-inferiority comparison of the test treatment to the 
control treatment 
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• 
The standard deviation for both test and control treatments is 0.5 mm 
• 
A difference between treatment groups of.:: 0.5 mm is considered clinically 
significant (i.e., the non-inferiority margin) 
• 
The difference between the treatment groups is expected to be 0 mm 
• 
Greater than 80% power is considered sufficient 
• 
Statistical test will be performed with a one-sided 5% significance level 
The hypotheses associated with the primary endpoint are defined as follows: 
Ha: µc.:: µs + 8 
H1: µc < µs + 8 
where µc is the mean change in crestal bone level for the test implants, µs is the mean 
change in crestal bone level for control implants, and 8 is the pre-defined non-inferiority 
margin of 0.5 mm. The study will be considered successful if the null hypothesis is 
rejected, i.e., the conclusion of non-inferiority is achieved. If non-inferiority is achieved at a 
one-sided a of 5%, a one-side superiority test will be performed at significance level of 5%. 
To maintain at least 80% power to detect a difference between treatment groups of 0.5 mm 
with a common standard deviation of 0.5 mm, 14 subjects per treatment group would be 
required for a total of 28 subjects. Adjusting for potential 25% attrition, 19 subjects per 
treatment group will be required for a total of 38 subjects. An additional 14 subjects will be 
enrolled in order to provide more data for the implant success and survival calculations, 
thereby bringing the total sample size to 52. 
8.2 
Randomization 
The randomization schedule will be generated and held by an independent statistician that 
will not participate in any other aspect of the study. Subjects will be randomized to either 
test or control in a 1: 1 ratio. 
The study randomization schedule will be stratified by study center to ensure that 
randomization is balanced across the two centers. Further, the randomization will use 
permuted blocks of appropriate size. 
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8.3 
Analysis Sets 
8.3.1 Modified Intention to Treat (mlTT) Analysis Set 
The analysis of the primary and secondary effectiveness measures will be based on 
the mlTT analysis set. The modified intent to treat analysis set consists of all subjects 
who are consented in the study, randomized, and received the study device. This 
analysis set will include subjects regardless of any protocol violations and/or premature 
termination. This analysis set includes the Per Protocol analysis set. 
8.3.2 Intention to Treat (ITT) Analysis Set 
The ITT analysis set consists of all subjects who are consented in the study, and 
randomized (i.e., enrolled). This population will include subjects regardless of any 
protocol violations and/or premature termination, or whether the subject actually 
received study treatment, and is based on the subject's randomization assignment 
rather than actual treatment received. The ITT analysis set will be used for presenting 
baseline data, procedural information, adverse events and protocol deviations. The ITT 
analysis set will also be used to provide a sensitivity analysis of the primary 
effectiveness endpoint. This analysis set includes the mlTT population. 
8.3.3 Per Protocol (PP) Analysis Set 
The PP analysis set consists of all subjects who are consented in the study, 
randomized, and received the study device according to the study protocol and 
randomization schedule. Subjects with significant protocol deviations (e.g., deviation of 
inclusion/exclusion criteria) will be excluded from this analysis set. Subjects with 
implants that do not reach primary stability will be excluded from this analysis set. 
Exclusion of subjects based on protocol deviations will be determined on a case-by-
case basis with input from the Principle Investigator and study statistician. The 
determination of which protocol deviations are significant enough to warrant exclusion 
from PP analysis population will be made while blinded to the subject's randomization 
assignment and primary endpoint result, and prior to final analysis. The PP analysis set 
will be used to provide a sensitivity analysis of the primary effectiveness endpoint. 
The results based on the ITT and PP analysis sets are intended only to assess the 
robustness of the primary findings based on the mlTT population. 
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8.4 
Effectiveness Analysis Methods 
8.4.1 Analysis of Primary Endpoint 
Change in crestal bone level between implant loading and 12 months post-loading will 
be measured as the primary endpoint. Cresta! bone levels on both the mesial and 
distal aspect of the implant will be considered and the mean of the two measurements 
will be used as the primary endpoint. If only one of the two measurements is available, 
the available measurement will be used in the analysis. The hypothesis tested is 
described in Section 8. 1. 
Mean change in crestal bone level between treatment groups will be compared via a 
one-sided t-test. If assumptions of normality are violated, an appropriate non-
parametric method or data transformation will be sought. 
Additional summaries with subjects categorized into one of the following groups based 
on the change in crestal bone level: bone gain, no change, 0 to <1 mm loss, 1 mm to 
<2 mm loss, 2 mm to <3 mm loss, and :2:3 mm loss will be presented. 
Summary statistics of the primary endpoint will be presented for raw values and 
change from baseline overall and by study center. If it is believed that the primary 
endpoint results may be affected by study center, ANCOVA methods may be used with 
treatment assignment as main effect and study center as a covariate. Other covariates, 
including implant site, implant length, racial data, age, gender, history of tobacco use, 
controlled diabetes, full-mouth plaque score, simultaneous grafting may also be added 
as covariates in the exploratory analyses. 
8.4.2 Analysis of Secondary Endpoints 
All secondary effectiveness endpoints will be summarized descriptively and no 
hypothesis tests are planned. Secondary endpoints include implant success and 
survival rates, implant stability as measured by RFA, dimensional changes of the 
buccal bone as measured on CBCT images, changes in soft tissue measurements 
(gingival and papilla margins - baseline at final restoration), and subject satisfaction 
(esthetics, function, and level of pain). 
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8.4.3 Analysis of Additional Endpoints 
Additional effectiveness measures will be collected at 24-, 36-, 48-, and 60-months 
post implant loading. These endpoints will be summarized descriptively and no 
hypothesis testing is planned. The additional endpoints include implant success and 
survival rates, dimensional changes of the buccal bone as measured on CBCT images, 
changes in soft tissue measurements (gingival and papilla margins - baseline at final 
restoration), and subject satisfaction (esthetics, function, and level of pain) .. 
8.4.4 Analysis of Safety Endpoints 
For analysis of safety endpoints, summary tables and/or listings will be provided for all 
adverse events by event category. Adverse events will also be summarized by 
relationship to the study device, implant procedure, by seriousness, severity and by 
outcome. Adverse events leading to discontinuation from the study will be tabulated. 
Except where indicated, a subject reporting the same adverse event more than once 
will be counted once when calculating the number and percentage of subjects with that 
particular event. Except where indicated, if a subject reports the same adverse event 
more than once, the strongest relationship to the procedure and/or device recorded for 
the event will be presented. 
Adverse events that occurred in screen failure subjects will be presented separately. 
8.5 
General Statistical Methods 
A qualified statistician using validated statistical software will perform all statistical analyses. 
Unless otherwise specified, the data will be summarized for non-missing subjects in tables 
listing the mean, standard deviation, minimum, maximum, and number of subjects in a 
group of continuous data, or number of subjects and percentage in each category for 
categorical data, as appropriate. In general the denominator for the percentage calculation 
will be based upon the total number of subjects (N) in the study population for the treatment 
groups, unless otherwise specified. 
All the statistical tests will be based on a 2-sided test at the significance level of 0.05, 
unless otherwise specified. 
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8.5.1 Balance in Baseline Characteristics 
To assess balance in baseline characteristics, the distribution of each baseline variable 
of interest will be compared between the two treatment groups. Continuous variables 
will be summarized using mean, median, standard deviation, 95% confidence interval, 
and range; testing between the two groups will be based on a two-sample t-test ( or 
Wilcoxon rank-sum test as appropriate). Categorical variables will be summarized 
using counts and percentages, and differences between treatment groups will be 
assessed using a Chi-square test (or Fisher's exact test as appropriate). 
All baseline demographic variables and other characteristics (including history of 
tobacco use, oral situation (number of missing teeth, natural teeth and number of 
implants), reason for tooth extraction/loss, modified sulcus bleeding index, pocket 
probing depths at 6 sites on adjacent teeth, and oral hygiene) will be summarized by 
treatment group. 
8.5.2 Surgery and Supporting Procedures 
Summaries of select surgery and other supportive measures will be presented by 
treatment group. 
Detailed information regarding the surgical procedure will be presented in listings. This 
will include information on crestal bone measurements, bone quality, evaluation of 
primary stability, guided bone regeneration, and soft tissue procedures. 
Details regarding other supportive procedures in the study will be presented in listings, 
including suture removal, second stage surgery, soft tissue procedures, impressions, 
temporary prosthesis placement, and final prosthesis placement. 
8.5.3 Other Data Summaries 
Concomitant medications will be presented in listings and also summarized by drug 
category. Protocol deviations will be summarized by deviation type and study center. 
8.5.4 Subject Disposition 
A detailed description of subject disposition will be provided by study group using a 
CONSORT diagram and summaries of subjects falling in various subgroups of interest, 
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such as enrolled but did not receive study treatment and early withdrawals. All enrolled 
(i.e., randomized) subjects entered in the study will be accounted for in the summary. 
8.5.5 Missing Data 
Every effort will be made to minimize the amount of missing data. If a subject drops 
out of the study prior to completing their primary endpoint assessment, every effort will 
be made to measure their primary endpoint immediately prior to discontinuation if 
possible. 
The primary effectiveness measure of change in crestal bone level will be based on 
available data. Sensitivity analyses based on last observation carried forward will be 
performed if missing data of the primary endpoint exceeds 10%. Other techniques for 
sensitivity may be explored. 
If standard statistical tests or clinical review indicate the presence of outliers for the 
primary endpoint, an additional analysis excluding such outliers will also be performed 
and the rationale for such exclusion will be described completely. 
9 
Data Management 
The general data management procedures are described below, details can be found in the 
Data Management Plan. 
Required clinical data for this study will be collected and recorded in the clinical database using 
an electronic case report form for all study subjects from whom informed consent is obtained. 
Site numbers and subject numbers will be used to track subject information throughout the 
registry. The Principal Investigator or authorized designee is responsible for the timely 
completion and electronic signature of all electronic case report forms. The information entered 
into the database will be checked systematically by the data management for inconsistent, 
illogical and/or missing data using electronic and manual validation checks defined in the Data 
Validation Plan. If validation of data leads to discrepancies, data management will generate 
electronic queries. The timely resolution of the queries is under the responsibility of the monitor 
and the investigators at site. The query process is an ongoing process starting with the first data 
entered into the database. 
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The electronic clinical data system used for this study has a security system that prevents 
unauthorized access to the data and any deletion of data (audit and edit trail). 
10 Study Management 
10.1 Regulatory and Ethical Requirements 
10.1.1 Informed Consent 
Informed consent will be obtained from all subjects prior to study participation as 
described in Section 4.1.1. 
10.1.2 Institutional Review Board 
Prior to initiation of any study procedures, the protocol and informed consent will be 
submitted to an IRB for review and approval. In addition, any amendments to the 
protocol or informed consent will be reviewed and approved (if necessary) by the IRB. 
The sponsor must receive a letter documenting the IRB approval at the center prior to 
the initiation of the study at the center. 
The investigator is responsible for providing the appropriate reports to the IRB during 
the course of the clinical study. This will include the following: 
• 
Informing the IRB of the study progress periodically as required, but at a 
minimum annually 
• 
Reporting any unanticipated serious adverse device effects within 10 working 
days of becoming aware of the event 
• 
Reporting any deviations from the protocol that adversely affect the risk/benefit 
ratio, the rights, safety, or welfare of the participants, or integrity of the study 
• 
Providing any other reports requested by the IRB 
10.2 Reports and Record Management 
10.2.1 Investigator Records 
The following will be required from the investigator prior to the initiation of the study: 
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• 
A signed confidentiality agreement 
• 
Signed and dated curriculum vitae of the investigator(s) and a copy of his/her 
dental license 
• 
Signed financial disclosure 
• 
A signed copy of the final protocol and any amendments 
• 
A signed copy of the clinical study agreement with the sponsor 
• 
IRB approval letter and IRB approved informed consent document 
10.2.2 Case Report Forms 
The investigator will be responsible for the accuracy of the data entered on the 
Electronic Case Report Forms (eCRFs). The investigator will also allow a Straumann 
representative and/or regulatory bodies to review the data reported on the case report 
form with the source documents as far as is permitted by local regulations. 
10.2.3 Source Documents 
Source documents are defined as the original point of entry of a specific data point. 
Source documents will include, but are not limited to, progress notes, electronic data, 
computer printouts, radiographs, and recorded data from automated instruments. All 
source documents pertaining to this study will be maintained by the investigator and 
made available for inspection by authorized persons. 
10.2.4 Records/Data Retention 
Original radiographs, photographs, and study documents will be maintained at the 
research center in a file established for this study. All study documentation needs to 
be stored at the research center for at least fifteen (15) years following the completion 
of the study, as specified by the sponsor. The investigator should have access to the 
study documents in order to answer any queries associated with the study. All other 
study records will be kept by Straumann once the study has been completed. These 
records will be maintained at Straumann according to Straumann standard operating 
procedures. 
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10.3 Monitoring 
Straumann will assign a qualified individual to monitor the study. The general monitoring 
procedures for this study are described below, details can be found in the Monitoring Plan. 
10.3.1 Study Initiation Visit 
Once a site receives IRB approval, the monitor will schedule a site initiation visit in 
order to make sure all study documents are in place and that all the site personnel that 
will participate in the study are trained on the study procedures. The monitor will 
ensure during the study initiation that the investigator clearly understands and accepts 
the responsibilities and obligations of conducting a clinical study: 
• 
Understands the clinical protocol and relevant items outlined in the protocol 
(including inclusion/exclusion criteria, AE and SAE reporting requirements) 
• 
Understands and accepts the obligations to obtain informed consent 
• 
Understands how to document study data (especially the importance of having 
supporting documentation for AE assessment) 
• 
Understands the information outlined in the investigator's brochure, including 
proper device usage 
• 
Understands aspects of study device accountability (i.e. how to obtain the 
device, how to store the device, how to document device receipt, usage and 
return) 
• 
Understands and accepts the obligation to obtain IRB review and approval of 
the protocol and informed consent, and to ensure continuing review of the study 
by the IRB 
• 
Has adequate facilities and access to an adequate number of suitable subjects 
to conduct the study 
10.3.2 Routine Monitoring Visits 
Monitoring visits will be scheduled and conducted periodically, but at a minimum 
annually to review the following: 
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• 
The study is in compliance with the currently approved protocol/ 
amendment(s); deviations will be discussed with the responsible investigator, 
documented, and reported to the sponsor and IRB (according to the IRB 
policy). 
• 
The study is in compliance with Good Clinical Practice (GCP) and with the 
applicable regulatory requirements 
• 
Only authorized investigators/ clinical personnel are participating in the 
clinical investigation 
• 
Device accountability including adequate supply at center, proper storage, 
and documentation of device traceability. 
• 
The reported study data entered on CRFs are accurate, complete, and 
verifiable from source documents 
• 
All adverse events and serious adverse events are reported correctly. In 
cases where there is missing information about an adverse event or missing 
evidence to support the investigator's assessment, a monitor will review and 
discuss the adverse event with the responsible investigator. 
• 
The reason for a subject's withdrawal has been documented 
The investigator will allow Straumann to have access to all study documents during 
each monitoring visit for a thorough review of the study's progress. 
10.3.3 Study Closeout Visit 
After the last subject has completed the study and the database has been cleaned, the 
closeout visit will be conducted at the center. The following tasks should be completed 
by Straumann or the monitor: 
• 
Review any outstanding questions from the Clinical Investigation Report and 
organize the signature process 
• 
Ensure that the documentation and clinical investigation requirements were 
met 
• 
Collect outstanding documents 
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• 
Ensure that adverse events were reported to the IRB according to the IRB's 
policy 
• 
Ensure that device accountability is complete 
• 
Organize the archiving of all study-related documents and remind the 
investigator of the obligation to retain the records 
10.4 Study Termination 
At study termination, a Clinical Investigation Report will be prepared by the sponsor, even if 
the study was terminated prematurely. 
The study can be terminated early at the discretion of the investigator or the sponsor in the 
case of any of the following: 
• 
Occurrence of adverse device effects unknown at the start of the study with 
respect to their nature, severity, and duration, or the unexpected excessive 
incidence of known adverse device effects 
• 
New scientific knowledge obtained after the start of the study showing the 
ethical claim of the study is no longer valid 
10.4.1 Center Discontinuation 
The study Center will be closed and the study terminated under the following 
circumstances: 
• 
The Center is not recruiting a sufficient number of subjects or is unlikely to 
recruit a sufficient number of subjects 
• 
The Center does not respond to study management requests 
• 
Repeated protocol violations have been discovered that effect the integrity of 
the study or the study data 
10.5 Protocol Amendments 
Once the first subject has entered the study, any part of this study plan can be amended 
upon agreement of the sponsor and the participating principal investigators throughout the 
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clinical investigation. Protocol changes will be kept to a minimum. Only those changes that 
are deemed essential to the successful completion of the protocol will be considered. 
The reasons and justifications for the amendment will be included with each amended 
section of the document, and the amendment will include a version number and date. Once 
the investigator and the sponsor have accepted the changes, a written amendment to the 
protocol will be sent to the investigator for signature. 
All significant protocol changes affecting the scientific soundness of the study or the rights, 
safety, or welfare of subjects which occur after the initial IRB approval, must be submitted 
for approval by each center to the IRB as an amendment to the original protocol before the 
changes can be implemented by the Investigator. Each investigational center will send a 
copy of the IRB approval letter for the amendment to Straumann. 
Requests for clarification statements to the protocol shall be discussed with the study 
monitor. The clarification statements will be sent to each investigator and will be kept in the 
appropriate file. 
10.6 Publications 
Analysis of data will be conducted by Straumann and the final report will be prepared by 
Straumann with input from the investigators. Any publications or presentations utilizing the 
data from this study must be reviewed by Straumann prior to submission according to the 
time frame specified in the clinical study agreement. 
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11 Protocol Signature Page 
Protocol: 
CR 01/14 
Study Title: 
Immediate Placement of the Straumann® Bone Level Tapered Implant with Early 
Loading in Single Tooth Gaps in the Maxilla and Mandible Compared to Delayed 
Placement 
Version: 
Version 5.0; Date: 29-Mar-2018 
I have read the foregoing protocol and agree to conduct the study as outlined. I agree that the 
examinations and follow-up visits required by the study protocol are in accordance with the 
standard treatment plan for dental implant subjects. 
Signature: 
Clinical Center Name 
Printed Name of Principal 
Investigator 
Received by Sponsor: 
Printed Name of Study Manager 
Protocol Version 5.0, 29-Mar-2018 
Clinical Center Number 
Signature of Principal 
Investigator 
Signature of Study Manager 
Date 
Date 
Page 71 of 84 

12 References 
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13 Chen ST, Beagle J, Jensen SS, Chiapasco M, Darby I. Consensus statements and 
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McMahan CA. Esthetic, clinical and patient-centered outcomes of immediately placed implants (Type 1) 
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failing osseointegrated titanium implants. Oral Microbiol lmmunol 1987: 2(4):145-151. 
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17 Grunder U. Stability of mucosa! topography around single-tooth implants and adjacent teeth: 1 year 
results. Int j periodontics Restorative Dent 2000;20:11-17. 
18 Albrektsson T, Isidor F. Consensus report of session IV. Proceedings of the 1st European Workshop 
on Periodontology. 1993. 
19 Laurel! L, Lundgren D. Marginal bone level changes at dental implants after 5 years in function: a 
meta-analysis. Clin Implant Dent Relat Res. 2011 Mar; 13(1 ): 19-28. 
Protocol Version 5.0, 29-Mar-2018 
Page 73 of 84 

Appendix 1 - Instructions for Use 
, s~,~~,:~~ 
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Instructions for use: Straumann"' Dental Implants: Roxolid'" Standard, Standard Plus, 
Standard Plus Narrow Neck CrossFit"', Tapered Effect, Bone Level and Bone Level Tapered 
@•/jftjffi# Gebrauchsanweisung: Straumann"' Zahnimplantate: Roxolid'" Standard, Standard Plus, Standard 
Plus Narrow Neck CrossFit"', Tapered Effect, Bone Level und Bone Level Tapered 
hfr\,/f\fW Mode d'emploi: Implants dentaires Straumann'": Roxolid"' Standard, Standard Plus, 
Standard Plus Narrow Neck CrossFit", Tapered Effect, Bone Level et Bone Level Tapered 
@l@foj,i,@ lstruzioni per l'uso: Straumann"' Dental Implants: Roxolid" Standard, Standard Plus, 
Standard Plus Narrow Neck CrossFit"', Tapered Effect,Bone Level e Bone Level Tapered 
@@1MM lnstrucciones de uso: lmplantes dentales Straumann"': Roxolid"' Standard, Standard Plus, 
Standard Plus Narrow Neck CrossFit"', Tapered Effect, Bone Level y Bone Level Tapered 
lnstru~oes de utiliza~ao: implantes dentarios Straumann"': Roxolid'" Standard, Standard Plus, 
Standard Plus Narrow Neck CrossFit", Tapered Effect, Bone Level e Bone Level Tapered 
Manufacturer/ Heroteller / Fabricant / 
Produttore / Fabricante / Fabricante 
.. 
!nstitut Straumann AG, Peter Merian-Weg 12 
CH-4002 Basel/Sv,itzedand, www.straumann.com 
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Protocol Version 5.0, 29-Mar-2018 
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Instructions for use: Straumann® Dental Implants: Roxolid® Standard, Standard Plus, 
Standard Plus Narrow Neck CrossFit®, Tapered Effect, Bone Level and Bone Level 
Tapered 
CAUTION: U.S. federal law restrids this device to 
sale by or on the order of a dental professional. 
Product Description 
The Straumann• Dental Implant System is an in-
tegrated system of endosseous dental Implants 
with corresponding abutments, healing abut-
ments, closure screws and surgical and prosthetic 
parts and instruments. 
Straumann·• Roxolid• Dental implants are solid 
screw implants comprised of a titanium-zirconium 
alloy with a SLActive·• bone anchorage surface 
that is large-grit sandblasted and acid-etched. In 
addition, SLAdive' is in a chemically activated 
state, which is preserved by storage in a NaCl solu-
tion.After removal from its liquid filled packaging, 
lhe properties of the SLAdive• surface are pre-
served for at least 15 minutes. The implant should 
be inserted within this period. 
Straumann• Dental implants used for guided 
surgery are specifically adapted with respect to 
the transfer piece. This ailows for guided implant 
insertion through the surgical template. 
Intended use 
The Straumann° Dental Implants are suitable for 
the treatment of oral endosleal implantation in 
the upper and lower Jaw and for the functional 
and eslheticoral rehabilitation of edenlulous and 
partially dentate patients. Straumann$ Dental im-
plants can be used for immediate orearlyimplan-
lation following extraction or lossofnatural teeth, 
Implants can be placed with immediate function 
on single-tooth and/or multiple-tooth applica-
tions when good primary stability is achieved 
and with appropriate occlusal loading, to restore 
chewing function_ The prosthetic restorations 
used are single crowns, bridges and partial or full 
dentures, which are connected lo the implants by 
the corresponding elements (abutments). 
The guided implants (implant with guided trans-
fer pieces) shall givelhe possibility to lhecustom-
erto insert an implant in a guided manner through 
a surgical template. 
Indications 
Straumann•· Dental implants are suitable for the 
treatment of oral endosteal implantation in the 
upper and lower jaw and for the functional and 
aesthetic oral rehabilitation of edentulous and 
partially dentate patients. Straumann'' Dental 
implants can also be used for immediate or early 
implantation following extraction or loss of natu• 
Protocol Version 5.0, 29-Mar-2018 
ral teeth. Implants can be placed with immediate 
function on single-tooth and/or multiple-tooth 
applications when good primary stability is 
achieved and with appropriate occlusal loading 
to restore chewing function. The prosthetic res-
torations used are single crowns, bridges and par-
tial or full dentures, which are connected to the 
implants through the corresponding components 
(abutments). 
Contraindications 
Inadequate bone volume and/or quality, local root 
remnants, serious internal medical problems, un-
controlled bleeding disorders, inadequate wound 
healing capacity, not completed maxillary and 
mandibular growth, poor general state of health, 
uncooperative, unmotivated patient, drug or al-
cohol abuse, psychoses, prolonged therapy-resis-
tant functional disorders, xerostomia, weakened 
immune system, illnesses requiring periodic use 
of steroids, uncontrollable endocrine disorders. 
Allergies or hypersensitivity lo chemical ingredi-
ents of materials used: titanium-zirconium alloy. 
Side effects, interactions and precautions; 
complications with Straumann implants 
Information related lo side effects, interactions 
and precautions; complications with Straumann 
implants should be provided to the patient. 
Immediately after the insertion of dental im-
plants, activities that demand considerable 
physical exertion should be avoided. Possible 
complications following the insertion of dental 
implants are: 
Temporary symptoms 
Pain, swelling, phonetic difficulties, gingival in-
flammation 
More persistent symptoms 
Chronic pain in connection wlth the dental im-
plant, permanent pareslhesia, dysesthesia, loss 
of maxillary /mandibular ridge bone, localized or 
systemic infection, oroantral or oronasal fistulae, 
unfavorably affected adjacent teeth, irreversible 
damage to adjacent teeth, fractures of implant, 
jaw, bone or prosthesis, aesthetic problems, nerve 
damage, exfolialion, hyperplasia 
Warning 
, Products must be secured against aspiration 
when handled intraorally. Aspiration of prod-
ucts may lead-to infection or unplanned physical 
injury. 
, Avoid approaching the proximilyoflhemandib-
ular nerve channel during implant bed prepara-
tion and implant insertion. Nerve damage may 
result in anesthesia, pareslhesia and dyslhesia. 
Cautions/Precautions 
, Always select the largest diameter implant 
that can be supported by the available bone 
thickness, bone quality, inter-dental spacing, 
and anticipated mastication forces. Particular 
care should be taken to assure proper implant 
alignment where comparatively high loads are 
expected. Small-diameter implants are not 
recommended forlhe posterior region. 
, A careful clinical and radiological examination 
of the patient should be performed prior to 
surgery to determine the psychological and 
physical status of the patient. Special attention 
should be given to patients who have local or 
systemic factors that could interfere with the 
healing process of either bone or soft !issue 
or the osseointegration process (e.g. bone 
metabolism disturbances, previously irradiated 
bone in the head or neck area, diabetes mellitus, 
anticoagulation drugs/hemorrhagic diatheses, 
bruxism, parafunclional habits, unfavorable 
anatomic bone conditions, tobacco abuse, 
untreated periodontal diseases, acute infection 
of implant site_. lemporomandibular joint 
disorders, treatable pathologic diseases of the 
Jaw and changes in the oral mucosa, pregnancy, 
inadequate oral hygiene). 
, Sterile handling is essential. Never use potential-
ly contaminated components. Contamination 
may lead to infections. 
, The implants must be stored in a dry place in 
the original packaging, protected from direct 
sunlight and at room temperature. Improper 
storage may compromis,; essential material and 
design characteristics leading to device failure. 
, Do not re-sterilize Straumann• Dental implants. 
Cleaning, disinfection and sterilization may com-
promise essential material and design charac-
teristics leading to device failure. 
, Do not re-use Straumann•· Dental implants. Re-
use of single-use devices creates a potential risk 
of patient or user infedions. 
, Avoid correcUons oftheverlical position using re-
verse rotations (countercloch..,ise). This can cause 
loosening of the screw-retained transfer piece 
and may lead to a decreased primary stability. 
, For Guided Surgery please make sure to uselhe 
slop key with the flat side pointing towards the 
sleeve,otherwiselhe implant cannolbe inserted 
to the final insertion depth. 
2 
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• The Straumann• Dental implants have not 
been evaluated for safety and compatibility 
in the Magnetic Resonance environment. The 
Straumann'' Dental implants have not been 
tested for heating or migration in the Magnetic 
Resonance environment. 
• Because of the reduced surface area for anchor-
age in the bone. implants with 6 mm length 
should be used for the following indications 
only: as an additional implant together with 
longer implants to support implant-borne re-
constructions or as an auxiliary implant for 
implant-borne bar constructions supporting 
full dentures in a seriously atrophied mandible. 
Compatibility information 
Straumann' Dental implants and the prosthetic 
lines synOcta~. CrossFit'' and Narrow Neck Cross-
Fit~ are available in a variety of configurations. 
Make sure that you use only Straumann" parts 
w,th the corresponding connection for the re-
storing of a Straumann• Dental implant (e.g. for 
prosthetic platform RN (Regular Ned) only com-
ponents marked with RN can be used). For further 
information see brochures "Basic Information" as 
mentioned in "Further Information". 
Only Straumann• Dental implants labelled with 
"Guided Surgery' are suitable for insertion through 
Straumann• Guided Surgery templates. For ad-
ditional information see "Basic Information on 
Straumann'· Guided Surgery-Straumann' Dental 
Implant System". 
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Cleaning and disinfection 
Straumann'' Dental implants are provided sterile 
and for single use only. They must not be cleaned 
and sterilized. lnstitutStraumann AG does not ac-
cept any responsibility for re-sterilized implants, 
regardless of who has carried out re-sterilization 
or by what method. 
Sterilization 
S!raumann' Dental implants are delivered sterile. 
The intact sterile packaging prote-._-is the sterilized 
implant from outside influences and, if stored cor-
rectly, ensures sterility upto the expiration dale. 
Protocol Version 5.0, 29-Mar-2018 
When removing the implant from the sterile 
packaging, rules of asepsis must be observed. 
The sterile packaging must not be opened until 
immediatel_v priorto insertion of the implant. Im-
plants with damaged sterile packaging must not 
be used. It is recommended to have a replacement 
implant on hand. 
lnstitut Shaumann does not accept any responsi-
bility for re-sterilized implants, regardless of who 
has carried out re-sterilization or by what meth-
od.A previously used or non-sterile implant must 
not be implanted under anycircumstances. lfthe 
original packaging is damaged, the contents will 
not be accepted back by lnstitut Straumann. 
Procedure 
Consult the brochures "Basic Information" as 
mentioned in "Further Information" for a detailed 
step-by-step description. 
Preoperative planning 
The implant diameter, implant type. position and 
number of implants should be selected individual-
ly laking the anatomy and spatial circumstances 
into account. The specific measurements should 
be regarded as minimum guidelines and are fur-
ther specified in the "Basic Information on the 
Surgical Techniques'". 
Implant bed preparation 
Thermal trauma prevents healing of a denbl im-
plant. Excessive rises in temperature must there-
fore be minimized by following the "Guidelines 
for the use of Straumann• Dental Implant Sys-
tem drills and instruments" regarding rotations 
per minute, intermittent drilling techniques and 
adequate cooling. 
Insertion of the implant 
A Straumann' Implant can be placed either 
manually with the ratchet or with the aid of 
thehandpiece. A maximum speed of IS rpm is 
rei;ommended. 
Treatment of soft tissue, wound closure 
Prior lo wound closure, the appropriate closure 
screi,v or healing cap is selede-d and sGewed on 
to the implant. Consult the corresponding pack· 
age insert when using healing caps and closure 
screw:,. 
Healing phase 
Straumann" Dental implants are suitable, within 
the scope of indications, for immediate and early 
restoration in single-tooth gaps and in an eden-
tulous or partially edentulous jaw. Good prima-
ry stability and an appropriate occlusal load are 
essential. 
In case of immediate restoration: In partiallyeden-
tulous 3aws two or more adjacent implants should 
be prosthet!cally connected together. In edentu-
lous jaws at least 4 implants must be connected 
together. For minima I healing time for relevant 
Straumann' Dental implants refer to the "Basic 
Information on the Surgical Procedures"'. 
Radiographic check is recommended after a 
healing phase before starting the prosthetic res-
toration. 
Further information 
You will find further information regarding treat-
ment recommendation and use of different types 
ofS!raumann ,, Dental implants and other compo-
nents oftheStraumann•· Dental Implant System 
in the documentation that is available on request 
from Straumann. Ensure that the following bro-
chures, in particular the surgical brochures, are 
available. 
Brochures: 
• "Basiclnformation on the Surgical Procedures-
Straumann'' Dental Implant System" 
• "Basic Information on the Surgical Procedures -
Straumann• Bone Level Tapered Implants" 
• "Basic Information on Straurnann·• Guided Sur-
gery- Straumann• Dental Implant System" 
• "Care and Maintenance of Surgical and Prosthet-
ic Instruments" 
Pad age inserts: 
• "Guidelines for the use of Straumann' Dental 
Implant System drills and instruments" 
• "Instructions for the useofStraumann• Dental 
Implant System closure screws, healing caps and 
healing abutments" 
Please note 
Practitioners must have knowledge of dental 
implantology and instruction in the handling 
of the Straumann• product described herein 
("Straumann Product") for using the Slraumann 
Product safely and properly in accordance with 
these Instructions for use. 
The Straumann Product must be used in accor-
dance with the instructions for use provided by 
the manufacturer. It is the pradrl:ioner's respon-
sibilit_v to use !he device in accordance with these 
instructions for use and to determine if the device 
fits to the individual patient situation. 
The Straumann Product is part of an overall con-
cept and must be used only in conjunction with 
the corresponding original components and in-
struments distributed by lnstilul Straumann 
AG. its ultimate parent company and all affil-
iates or subsidiaries of such parent company 
("Straumann"). Use of products made by third 
parties, which are not distributed by Straumann, 
will void any warranty or other obligation. express 
Version (RD-RR-RT/max.): 07 /07 
Page 76 of 84 
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or implied, ofStraumann. 
Validity 
Upon publication of these instructions for use, all 
previous versions are superseded, 
© lnstitut StraumannAG, 2015.AII rights reserved. 
Siraumannr, and/or other trademarks and logos 
from Straumann zs mentioned herein are the trade~ 
marks or registered trademarks of Straumann 
Holding AG and/or its affiliates. 
Availability 
Some Items of the Straumann• Dental Implant 
System are not available in all countries. 
( E orn Straumann Products with the CE mark 
fulfill the requirements ofthe Medical 
Devices Directive 93/42 EEC 
[ill 
® 
ltoTI 
~ 
!REFI 
Consult in~tructions. for use 
Please follow the link to the e-lFU 
www.ifu.straumann.com 
Do not re-use 
Balch code 
Use before expiry date 
Article number 
..: Manufacturer 
,,iv 
'ki,'\;' 
Keep away from sunlight 
• 
~ 
Sterilized using irradfation 
~x only 
U.S. federal law restricts this device 
to sale by or on the order of a dental 
professional. 
Protocol Version 5.0, 29-Mar-2018 
4 
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Appendix 2 - Declaration of Helsinki 
Adopted by the 18th WMA General Assembly, Helsinki, Finland, June 1964 
and amended by the: 
29th WMA General Assembly, Tokyo, Japan, October 1975 
35th WMA General Assembly, Venice, Italy, October 1983 
41 st WMA General Assembly, Hong Kong, September 1989 
48th WMA General Assembly, Somerset West, Republic of South Africa, October 1996 
52nd WMA General Assembly, Edinburgh, Scotland, October 2000 
53rd WMA General Assembly, Washington DC, USA, October 2002 (Note of Clarification 
added) 
55th WMA General Assembly, Tokyo, Japan, October 2004 (Note of Clarification added) 
59th WMA General Assembly, Seoul, Republic of Korea, October 2008 
64th WMA General Assembly, Fortaleza, Brazil, October 2013 
Preamble 
1. The World Medical Association (WMA) has developed the Declaration of Helsinki as a 
statement of ethical principles for medical research involving human subjects, including 
research on identifiable human material and data. 
The Declaration is intended to be read as a whole and each of its constituent paragraphs should 
be applied with consideration of all other relevant paragraphs. 
2. Consistent with the mandate of the WMA, the Declaration is addressed primarily to 
physicians. The WMA encourages others who are involved in medical research involving human 
subjects to adopt these principles. 
General PrinciQles 
3. The Declaration of Geneva of the WMA binds the physician with the words, "The health of my 
patient will be my first consideration," and the International Code of Medical Ethics declares 
that, "A physician shall act in the patient's best interest when providing medical care." 
4. It is the duty of the physician to promote and safeguard the health, well-being and rights of 
patients, including those who are involved in medical research. The physician's knowledge and 
conscience are dedicated to the fulfilment of this duty. 
5. Medical progress is based on research that ultimately must include studies involving human 
subjects. 
6. The primary purpose of medical research involving human subjects is to understand the 
causes, development and effects of diseases and improve preventive, diagnostic and 
Protocol Version 5.0, 29-Mar-2018 
Page 78 of 84 

therapeutic interventions (methods, procedures and treatments). Even the best proven 
interventions must be evaluated continually through research for their safety, effectiveness, 
efficiency, accessibility and quality. 
7. Medical research is subject to ethical standards that promote and ensure respect for all 
human subjects and protect their health and rights. 
8. While the primary purpose of medical research is to generate new knowledge, this goal can 
never take precedence over the rights and interests of individual research subjects. 
9. It is the duty of physicians who are involved in medical research to protect the life, health, 
dignity, integrity, right to self-determination, privacy, and confidentiality of personal information 
of research subjects. The responsibility for the protection of research subjects must always rest 
with the physician or other health care professionals and never with the research subjects, even 
though they have given consent. 
10. Physicians must consider the ethical, legal and regulatory norms and standards for research 
involving human subjects in their own countries as well as applicable international norms and 
standards. No national or international ethical, legal or regulatory requirement should reduce or 
eliminate any of the protections for research subjects set forth in this Declaration. 
11. Medical research should be conducted in a manner that minimizes possible harm to the 
environment. 
12. Medical research involving human subjects must be conducted only by individuals with the 
appropriate ethics and scientific education, training and qualifications. Research on patients or 
healthy volunteers requires the supervision of a competent and appropriately qualified physician 
or other health care professional. 
13. Groups that are underrepresented in medical research should be provided appropriate 
access to participation in research. 
14. Physicians who combine medical research with medical care should involve their patients in 
research only to the extent that this is justified by its potential preventive, diagnostic or 
therapeutic value and if the physician has good reason to believe that participation in the 
research study will not adversely affect the health of the patients who serve as research 
subjects. 
15. Appropriate compensation and treatment for subjects who are harmed as a result of 
participating in research must be ensured. 
Risks1 Burdens and Benefits 
16. In medical practice and in medical research, most interventions involve risks and burdens. 
Medical research involving human subjects may only be conducted if the importance of the 
objective outweighs the risks and burdens to the research subjects. 
Protocol Version 5.0, 29-Mar-2018 
Page 79 of 84 

17. All medical research involving human subjects must be preceded by careful assessment of 
predictable risks and burdens to the individuals and groups involved in the research in 
comparison with foreseeable benefits to them and to other individuals or groups affected by the 
condition under investigation. 
Measures to minimize the risks must be implemented. The risks must be continuously 
monitored, assessed and documented by the researcher. 
18. Physicians may not be involved in a research study involving human subjects unless they 
are confident that the risks have been adequately assessed and can be satisfactorily managed. 
When the risks are found to outweigh the potential benefits or when there is conclusive proof of 
definitive outcomes, physicians must assess whether to continue, modify or immediately stop 
the study. 
Vulnerable GrouQ_s and Individuals 
19. Some groups and individuals are particularly vulnerable and may have an increased 
likelihood of being wronged or of incurring additional harm. 
All vulnerable groups and individuals should receive specifically considered protection. 
20. Medical research with a vulnerable group is only justified if the research is responsive to the 
health needs or priorities of this group and the research cannot be carried out in a non-
vulnerable group. In addition, this group should stand to benefit from the knowledge, practices 
or interventions that result from the research. 
Scientific Reguirements and Research Protocols 
21. Medical research involving human subjects must conform to generally accepted scientific 
principles, be based on a thorough knowledge of the scientific literature, other relevant sources 
of information, and adequate laboratory and, as appropriate, animal experimentation. The 
welfare of animals used for research must be respected. 
22. The design and performance of each research study involving human subjects must be 
clearly described and justified in a research protocol. 
The protocol should contain a statement of the ethical considerations involved and should 
indicate how the principles in this Declaration have been addressed. The protocol should 
include information regarding funding, sponsors, institutional affiliations, potential conflicts of 
interest, incentives for subjects and information regarding provisions for treating and/or 
compensating subjects who are harmed as a consequence of participation in the research 
study. 
In clinical trials, the protocol must also describe appropriate arrangements for post-trial 
provisions. 
Protocol Version 5.0, 29-Mar-2018 
Page 80 of 84 

Research Ethics Committees 
23. The research protocol must be submitted for consideration, comment, guidance and 
approval to the concerned research ethics committee before the study begins. This committee 
must be transparent in its functioning, must be independent of the researcher, the sponsor and 
any other undue influence and must be duly qualified. It must take into consideration the laws 
and regulations of the country or countries in which the research is to be performed as well as 
applicable international norms and standards but these must not be allowed to reduce or 
eliminate any of the protections for research subjects set forth in this Declaration. 
The committee must have the right to monitor ongoing studies. The researcher must provide 
monitoring information to the committee, especially information about any serious adverse 
events. No amendment to the protocol may be made without consideration and approval by the 
committee. After the end of the study, the researchers must submit a final report to the 
committee containing a summary of the study's findings and conclusions. 
Privacy and Confidentiality 
24. Every precaution must be taken to protect the privacy of research subjects and the 
confidentiality of their personal information. 
Informed Consent 
25. Participation by individuals capable of giving informed consent as subjects in medical 
research must be voluntary. Although it may be appropriate to consult family members or 
community leaders, no individual capable of giving informed consent may be enrolled in a 
research study unless he or she freely agrees. 
26. In medical research involving human subjects capable of giving informed consent, each 
potential subject must be adequately informed of the aims, methods, sources of funding, any 
possible conflicts of interest, institutional affiliations of the researcher, the anticipated benefits 
and potential risks of the study and the discomfort it may entail, post-study provisions and any 
other relevant aspects of the study. The potential subject must be informed of the right to refuse 
to participate in the study or to withdraw consent to participate at any time without reprisal. 
Special attention should be given to the specific information needs of individual potential 
subjects as well as to the methods used to deliver the information. 
After ensuring that the potential subject has understood the information, the physician or 
another appropriately qualified individual must then seek the potential subject's freely-given 
informed consent, preferably in writing. If the consent cannot be expressed in writing, the non-
written consent must be formally documented and witnessed. 
All medical research subjects should be given the option of being informed about the general 
outcome and results of the study. 
27. When seeking informed consent for participation in a research study the physician must be 
particularly cautious if the potential subject is in a dependent relationship with the physician or 
Protocol Version 5.0, 29-Mar-2018 
Page 81 of 84 

may consent under duress. In such situations the informed consent must be sought by an 
appropriately qualified individual who is completely independent of this relationship. 
28. For a potential research subject who is incapable of giving informed consent, the physician 
must seek informed consent from the legally authorized representative. These individuals must 
not be included in a research study that has no likelihood of benefit for them unless it is 
intended to promote the health of the group represented by the potential subject, the research 
cannot instead be performed with persons capable of providing informed consent, and the 
research entails only minimal risk and minimal burden. 
29. When a potential research subject who is deemed incapable of giving informed consent is 
able to give assent to decisions about participation in research, the physician must seek that 
assent in addition to the consent of the legally authorized representative. The potential subject's 
dissent should be respected. 
30. Research involving subjects who are physically or mentally incapable of giving consent, for 
example, unconscious patients, may be done only if the physical or mental condition that 
prevents giving informed consent is a necessary characteristic of the research group. In such 
circumstances the physician must seek informed consent from the legally authorized 
representative. If no such representative is available and if the research cannot be delayed, the 
study may proceed without informed consent provided that the specific reasons for involving 
subjects with a condition that renders them unable to give informed consent have been stated in 
the research protocol and the study has been approved by a research ethics committee. 
Consent to remain in the research must be obtained as soon as possible from the subject or a 
legally authorized representative. 
31. The physician must fully inform the patient which aspects of their care are related to the 
research. The refusal of a patient to participate in a study or the patient's decision to withdraw 
from the study must never adversely affect the patient-physician relationship. 
32. For medical research using identifiable human material or data, such as research on 
material or data contained in biobanks or similar repositories, physicians must seek informed 
consent for its collection, storage and/or reuse. There may be exceptional situations where 
consent would be impossible or impracticable to obtain for such research. In such situations the 
research may be done only after consideration and approval of a research ethics committee. 
Use of Placebo 
33. The benefits, risks, burdens and effectiveness of a new intervention must be tested against 
those of the best proven intervention(s), except in the following circumstances: 
Where no proven intervention exists, the use of placebo, or no intervention, is acceptable; or 
Where for compelling and scientifically sound methodological reasons the use of any 
intervention less effective than the best proven one, the use of placebo, or no intervention is 
necessary to determine the efficacy or safety of an intervention 
Protocol Version 5.0, 29-Mar-2018 
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and the patients who receive any intervention less effective than the best proven one, placebo, 
or no intervention will not be subject to additional risks of serious or irreversible harm as a result 
of not receiving the best proven intervention. 
Extreme care must be taken to avoid abuse of this option. 
Post-Trial Provisions 
34. In advance of a clinical trial, sponsors, researchers and host country governments should 
make provisions for post-trial access for all participants who still need an intervention identified 
as beneficial in the trial. This information must also be disclosed to participants during the 
informed consent process. 
Research Registration and Publication and Dissemination of Results 
35. Every research study involving human subjects must be registered in a publicly accessible 
database before recruitment of the first subject. 
36. Researchers, authors, sponsors, editors and publishers all have ethical obligations with 
regard to the publication and dissemination of the results of research. Researchers have a duty 
to make publicly available the results of their research on human subjects and are accountable 
for the completeness and accuracy of their reports. All parties should adhere to accepted 
guidelines for ethical reporting. Negative and inconclusive as well as positive results must be 
published or otherwise made publicly available. Sources of funding, institutional affiliations and 
conflicts of interest must be declared in the publication. Reports of research not in accordance 
with the principles of this Declaration should not be accepted for publication. 
Un2,roven Interventions in Clinical Practice 
37. In the treatment of an individual patient, where proven interventions do not exist or other 
known interventions have been ineffective, the physician, after seeking expert advice, with 
informed consent from the patient or a legally authorised representative, may use an unproven 
intervention if in the physician's judgement it offers hope of saving life, re-establishing health or 
alleviating suffering. This intervention should subsequently be made the object of research, 
designed to evaluate its safety and efficacy. In all cases, new information must be recorded and, 
where appropriate, made publicly available. 
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Appendix 3 - Visual Analog Scale 
,straumann 
CR 01114 
Visit 9 
12 M10nth Follow-Up 
To be completed by lhe patient - comment on the implant -ii!nd supported r:mJWJl 
Pain associated with the implant and crown 
Please mark your paio level be drawing one vertic,al mark I 1hrough the One betow. 
Painful 
No pain 
Satisfaction with the function 
Pl,aase mark your paln level be drawing one vertical mark I Uirou,gh the Hna below. 
Net Satisfied 
···-·---····-···----··-----·-·-··-~-------------
Highly 
Satisfl.ed 
Satisfaction with the e+stheties 
Please mark your paio level be drawing one vertical mark 
Not Satisfied 
Patient'~ S,gneture: 
Oate 
Protocol Version 5.0, 29-Mar-2018 
I 1h rough the line below. 
Highly 
Satisfied 
. ,1 l I I ,1 
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