A Multi-Center, Prospective, Single Cohort, Post-Market Clinical Follow-Up (PMCF) Study to Assess Implant Survival After Insertion of Straumann® Bone Level Tapered (BLT) Implant Ø 2.9 mm in the Clinical Practice Setting
Phase: NA
Conditions: Tooth Loss
Sponsor: Institut Straumann AG

 
 
 
 
 
 
A Multi-Center, Prospective, Single Cohort, Post-Market Clinical 
Follow-Up (PMCF) Study to Assess Implant Survival after Insertion of 
Straumann® Bone Level Tapered (BLT) Implant Ø 2.9 mm in the Clinical 
Practice Setting 
 
CR 02/15 
 
Date: 09-Aug-2017 
Version 2.0 
 
 
Results published on clinicaltrials.gov. 
Identifier: NCT02699866 
 
 
 

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Contact Information  
Coordinating Investigator: 
Dr. med. Dr. med. dent. Keyvan Sagheb 
Universitätsmedizin 
der Johannes Gutenberg-Universität Mainz 
Klinik für Mund-Kiefer-Gesichtschirurgie, 
Plastische Operationen 
Augustusplatz 2 
55131 Mainz 
Germany 
+49 6131 17 3761 – Phone  
+49 6131 17 6602 – Fax  
keyvan.sagheb@unimedizin-mainz.de 
Principal Investigator: 
Univ.-Prof. Dr. med. Dr. med. dent. Johannes 
Kleinheinz 
Universitätsklinikum Münster 
Klinik für Mund-, Kiefer- und 
Gesichtschirurgie  
Albert-Schweitzer-Campus 1 
Waldeyerstraße 30 
48149 Münster 
Germany 
+49 251 83 470 04 – Phone 
+49 251 83 4 71 84 – Fax 
Johannes.Kleinheinz@ukmuenster.de 
Principal Investigator: 
Priv.-Doz. Dr. Dr. Marcus Klein  
Kieferchirurgische Gemeinschaftspraxis 
Dr. Dr. Stroink & Kollegen 
Stresemannstraße 7-9 
40210 Düsseldorf 
Germany 
+49 211 87 550 80 – Phone  
+49 211 87 550 899 – Fax 
marcusoklein@me.com 

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Principal Investigator: 
Jan Herrmann 
Kieferchirurgische Praxen Hentschel & 
Herrmann 
Lothar-Streit-Straße 10b 
08056 Zwickau 
Germany 
+49 375 303 50 90 – Phone 
+49 375 303 50 919 – Fax  
info@hentschel-herrmann.de 
roentgen@hentschel-herrmann.de 
Principal Investigator: 
Prof. Dr. med. Dr. med. dent. Christian 
Walter 
medi+ 
Zahnärztliche Praxisklinik 
Haifa-Allee 20 
55128 Mainz 
Germany 
+49 6131 490 808 5 – Phone 
+49 6131 490 808 9 – Fax 
studien@mainz-mkg.de 
Sponsor: 
Institut Straumann AG 
Peter Merian Weg 12 
4002 Basel 
Switzerland 
Sponsor Representatives: 
 
Study Manager: 
Irène Frank, PhD 
Clinical Trial Leader 
Institut Straumann AG 
Peter Merian Weg 12 
4002 Basel 
Switzerland  
+41 61 965 14 27– Phone 
+41 61 965 11 10 – Fax 
irene.frank@straumann.com 
Head Clinical Operations: 
Michel Mallaun, PhD 

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Head Clinical Operations 
Institut Straumann AG 
Peter Merian Weg 12 
4002 Basel 
Switzerland  
+41 61 965 14 23 – Phone 
+41 61 965 11 10 – Fax 
michel.mallaun@straumann.com 

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Abbreviations 
 
Ø  
Diameter 
ADE 
Adverse Device Effect 
AE 
Adverse Event 
ASADE 
Anticipated Serious Adverse Device Effect 
BLT 
Bone Level Tapered 
CBCT 
Cone-Beam Computed Tomography 
eCRF 
Electronic Case Report Form 
DD 
Device Deficiencies 
EC 
Ethics Committee 
EDC  
Electronic Data Capturing 
FAS 
Full Analysis Set 
FDI 
Federation Dentaire Internationale 
GCP 
Good Clinical Practice 
IfU 
Instructions for Use 
ISO 
International Organization for Standardization 
ITI  
International Team for Implantology 
mSBI 
modified Sulcus Bleeding Index 
PES 
Pink Esthetic Score 
PI  
Plaque Index 
PMCF 
Post-Market Clinical Follow-Up  
PPS 
Per-protocol set 
PPD 
Probing Pocket Depth 

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SAS 
Safety analysis set 
SADE 
Serious Adverse Device Effect 
SAE  
Serious Adverse Event 
SLA  
Sand blasted, Large grit, Acid etched surface 
SC 
Small CrossFit 
SOP 
Standard Operating Procedure 
USADE  Unanticipated Serious Adverse Device Effect 

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Synopsis 
Study Title 
A Multi-Center, Prospective, Single Cohort, Post-Market Clinical 
Follow-Up (PMCF) Study to Assess Implant Survival after Insertion of 
Straumann® Bone Level Tapered (BLT) Implant Ø 2.9 mm in the Clinical 
Practice Setting 
Study Protocol Number 
CR 02/15 
Study Registration 
This protocol will be registered at clinicaltrials.gov at the study start. 
Objectives 
The aim of this study is to provide short-term data on the performance 
and safety of the Straumann® BLT implant Ø 2.9 mm in the clinical 
practice setting.  
The primary objective of this PMCF study is to assess implant survival at 
12 months after implant placement of the Straumann® BLT implant 
Ø 2.9 mm in usual clinical practice setting in partially healed extraction 
socket of the central and lateral incisors in the mandible and lateral 
incisors in the maxilla for single tooth replacement. 
The secondary objectives of the study are to assess the Pink Esthetic 
Score (PES) at 6 months after implant placement, the implant success 
and the marginal bone level changes at 12 months after implant 
placement, and the incidence of Adverse Events (AEs) and Adverse 
Device Effects (ADEs). 
Design 
A multi-center, prospective, single cohort, PMCF study.  
Study Population 
Male or female patients 18 years of age or older who are in need of a 
single tooth replacement with a dental implant in central and lateral 
incisors in the mandible and lateral incisors in the maxilla, and meet all 
of the inclusion but none of the exclusion criteria listed below. 
Patient Inclusion Criteria 
The following criteria must be met for inclusion in the study: 
 
Patients must have voluntarily signed the Informed Consent 
Form before any study related procedures are performed, are 
willing and able to attend scheduled follow-up visits, and agree 
that the pseudonymized data will be collected and analyzed. 
 
Patients must be males or females who are a minimum of 
18 years of age. 
 
Patients with a minimum of 4 weeks history of edentulism in the 
study area, minimal interdental space and in need of a single 
tooth replacement with a dental implant in central and lateral 
incisors in the mandible and lateral incisors in the maxilla 
(Federation Dentaire Internationale (FDI) positions 12, 22, 31, 
32, 41 or 42). 
 
Presence of natural tooth or implants adjacent to the study 
implant position (single tooth gap). 
 
Patients with complete soft tissue coverage of the socket at the 
Baseline Visit. 
Patient Exclusion Criteria 
Patients matching any contraindication as stated in the Instructions for 
Use (IfU) should be excluded: 
 
Patients with inadequate bone volume and / or quality. 
 
Patients with local root remnants. 
 
Patients with inadequate wound healing capacity. 
 
Patients with not completed maxillary and mandibular growth. 

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 
Patients with serious internal medical problems, uncontrolled 
bleeding disorders, psychoses, prolonged therapy-resistant 
functional disorders, xerostomia, weakened immune system, 
illnesses requiring periodic use of steroids or uncontrollable 
endocrine disorders. 
 
Patients with poor general state of health. 
 
Patients with drug or alcohol abuse. 
 
Patients with allergies or hypersensitivity to chemical ingredients 
of titanium-zirconium alloy. 
 
Patients 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.  
 
A woman who is pregnant or planning to become pregnant at 
any point during the study duration. 
Study Treatment 
Placement of Straumann® BLT implants Ø 2.9 mm in central and lateral 
incisors in the mandible and lateral incisors in the maxilla in at least 
40 patients for single tooth replacement followed by prosthetic loading 
(only 1 implant per patient is assessed). 
Treatment Plan 
Visit # 
Visit 
Schedule 
Visit 1 
Screening 
Up to 2 months before 
implant placement 
Visit 2 
Implant Placement 
(Baseline) 
Day 0 
Visit 3 
Suture Removal 
7 to 14 days after 
implant placement 
Visit 4 
Provisional Crown 
6 weeks ± 2 weeks 
after implant 
placement 
Visit 5 
Final Crown 
4 months ± 1 month 
after implant 
placement 
Visit 6 
6-month Follow-Up 
6 months ± 1 month 
after implant 
placement 
Visit 7 
12-month Follow-Up 
12 months ± 1 month 
after implant 
placement 
Study Device 
Straumann® BLT implant Ø 2.9 mm Roxolid® SLActive®, available in 
lengths of 10, 12 and 14 mm.  
Registration Status 
CE-marking for the Straumann® BLT implant Ø 2.9 mm is expected 
during the second half year of 2015. The study will not start until 
CE-clearance has been received. 

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Primary Analysis 
The analysis will be conducted after all patients completed the 12-month 
Follow-Up Visit. Baseline is implant placement. 
Primary Endpoint 
 
Implant survival at 12 months after implant placement 
Secondary Endpoints 
 
PES at 6 months after implant placement 
 
Implant success at 12 months after implant placement 
 
Marginal bone level changes at 12 months after implant 
placement 
 
AEs and ADEs incidence 
Statistical Considerations 
Descriptive statistics will be performed. 
Safety 
The patients will be monitored for AEs and ADEs by the Investigators 
from the start of implant placement at the Baseline Visit until the last 
protocol-specific procedure of a patient. 
Participating Country 
Germany 
Number of participating 
centers 
5 study centers 
Number of Patients 
At least 40 patients 
Estimated Date of First Patient 
In / Study Start  
October 2015 (after CE-marking) 
Estimated Date of Last Patient 
In  
December 2017 
Estimated Date of Last Patient 
Out / Study End 
December 2018 (12-month Follow-Up Visit completed by all patients) 
Sponsor 
Institut Straumann AG 
Investigators 
Dr. Dr. Keyvan Sagheb (Coordinating Investigator), University Mainz 
Prof. Dr. Dr. Johannes Kleinheinz, University Münster 
Priv.-Doz. Dr. Dr. Marcus Klein, Private Practice Stroink, Düsseldorf 
Jan Herrmann, Private Practice Hentschel & Herrmann, Zwickau 
Prof. Dr. Dr. Christian Walter, medi+, Mainz 
Compliance 
This study and any amendments will be performed according to 
International Organization for Standardization (ISO) 14155:2011 as 
applicable for post-market studies, ICH E6(R1) Guideline on Good 
Clinical Practice (GCP) 1996, local legal and regulatory requirements, 
and conformed to the Declaration of Helsinki (last revision Fortaleza 
2013). 

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Table of Content 
CONTACT INFORMATION .......................................................................................... 2 
ABBREVIATIONS ........................................................................................................ 5 
1 
BACKGROUND AND STUDY RATIONALE ..................................................... 13 
2 
OBJECTIVES ..................................................................................................... 13 
2.1 
PRIMARY OBJECTIVE ................................................................................................................ 13 
2.2 
SECONDARY OBJECTIVES ......................................................................................................... 14 
3 
STUDY DESIGN ................................................................................................ 14 
3.1 
TYPE AND DESIGN OF THE STUDY .............................................................................................. 14 
3.2 
INDICATIONS AND CONTRA-INDICATIONS .................................................................................... 14 
3.3 
STUDY TREATMENT .................................................................................................................. 14 
3.4 
ENDPOINTS............................................................................................................................... 15 
3.4.1 
Primary Endpoint ......................................................................................................... 15 
3.4.2 
Secondary Endpoints .................................................................................................. 15 
3.5 
STUDY SAMPLE SIZE ................................................................................................................ 15 
3.6 
STUDY DURATION ..................................................................................................................... 15 
3.7 
STUDY POPULATION ................................................................................................................. 15 
3.7.1 
Inclusion Criteria .......................................................................................................... 16 
3.7.2 
Exclusion Criteria ........................................................................................................ 16 
4 
DEVICE DESCRIPTION AND SPECIFICATIONS ............................................. 17 
4.1 
STRAUMANN BONE LEVEL TAPERED IMPLANT Ø 2.9 MM ............................................................ 17 
4.2 
PRODUCT REGISTRATION STATUS ............................................................................................. 18 
4.3 
INSTRUCTIONS FOR USE, HANDLING AND LABELING ................................................................... 18 
4.4 
STORAGE ................................................................................................................................. 18 
4.5 
DEVICE ACCOUNTABILITY.......................................................................................................... 18 
4.6 
RETURN OF STUDY DEVICE ....................................................................................................... 19 
5 
RISK ANALYSIS, RISK/ BENEFITS.................................................................. 19 
6 
SCHEDULE OF ASSESSMENTS ...................................................................... 20 
6.1 
VISIT WINDOWS ........................................................................................................................ 22 
6.2 
SCREENING VISIT (VISIT 1) ........................................................................................................ 22 
6.3 
IMPLANT PLACEMENT (BASELINE; VISIT 2) ................................................................................. 23 
6.4 
SUTURE REMOVAL (VISIT 3) ...................................................................................................... 23 
6.5 
PROVISIONAL CROWN (VISIT 4) ................................................................................................. 23 
6.6 
FINAL IMPRESSION (NOT A SCHEDULED VISIT) ............................................................................. 24 
6.7 
FINAL CROWN (VISIT 5) ............................................................................................................. 24 
6.8 
FOLLOW-UP AFTER 6 MONTHS (VISIT 6) .................................................................................... 25 
6.9 
FOLLOW-UP AFTER 12 MONTHS (VISIT 7) .................................................................................. 25 
7 
STUDY EVALUATIONS ..................................................................................... 26 
7.1 
INFORMED CONSENT ................................................................................................................. 26 
7.2 
PREGNANCY TEST .................................................................................................................... 26 
7.3 
DEMOGRAPHICS ....................................................................................................................... 27 
7.4 
SMOKING STATUS ..................................................................................................................... 27 
7.5 
INCLUSION AND EXCLUSION CRITERIA ....................................................................................... 27 
7.6 
MEDICAL AND DENTAL HISTORY / PRE-OPERATIVE PLANNING .................................................... 27 
7.7 
ORAL HYGIENE ASSESSMENT ................................................................................................... 27 
7.8 
PLAQUE INDEX ......................................................................................................................... 28 
7.9 
MODIFIED SULCUS BLEEDING INDEX .......................................................................................... 28 
7.10 
PROBING POCKET DEPTH ......................................................................................................... 28 
7.11 
PHOTOGRAPH OF THE IMPLANT SITE .......................................................................................... 29 

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7.12 
PANORAMIC RADIOGRAPH OR CONE-BEAM COMPUTED TOMOGRAPHY SCAN.............................. 29 
7.12.1 
Bone Level Changes .................................................................................................... 29 
7.13 
IMPLANT SUCCESS CRITERIA..................................................................................................... 30 
7.14 
IMPLANT SURVIVAL ................................................................................................................... 30 
7.15 
PINK ESTHETIC SCORE ............................................................................................................. 31 
7.16 
ADVERSE EVENTS .................................................................................................................... 32 
7.17 
CONCOMITANT MEDICATION ...................................................................................................... 32 
7.18 
DETAILS OF IMPLANT PLACEMENT ............................................................................................. 32 
7.19 
PROVISIONAL CROWN DESCRIPTION .......................................................................................... 33 
7.20 
FINAL CROWN DESCRIPTION ..................................................................................................... 33 
8 
EVALUATION OF ADVERSE EVENTS AND DEVICE DEFICIENCY ............... 33 
8.1 
DEFINITION ............................................................................................................................... 33 
8.1.1 
Adverse Event .............................................................................................................. 33 
8.1.2 
Serious Adverse Event ................................................................................................ 34 
8.1.3 
Device Deficiency ........................................................................................................ 34 
8.1.4 
Adverse Device Effect ................................................................................................. 35 
8.1.5 
Serious Adverse Device Effect ................................................................................... 35 
8.1.6 
Unanticipated Serious Adverse Device Effect .......................................................... 35 
8.1.7 
Anticipated Serious Adverse Device Effect .............................................................. 35 
8.2 
ASSESSMENT OF ADVERSE EVENTS .......................................................................................... 35 
8.2.1 
Seriousness .................................................................................................................. 35 
8.2.2 
Relationship to the Study Device or Procedure ....................................................... 36 
8.2.3 
Severity ......................................................................................................................... 36 
8.2.4 
Expectedness ............................................................................................................... 36 
8.2.5 
Outcome ....................................................................................................................... 38 
8.3 
PROCEDURE FOR REPORTING ADVERSE EVENTS AND DEVICE DEFICIENCIES .............................. 39 
8.3.1 
Adverse Event Reporting ............................................................................................ 39 
8.3.2 
Serious Adverse Event Reporting .............................................................................. 39 
8.3.3 
Device Deficiency Reporting ...................................................................................... 40 
8.3.4 
Adverse Device Effects Reporting ............................................................................. 40 
8.3.5 
Serious Adverse Device Effect Reporting ................................................................. 41 
8.3.6 
Additional Safety Reporting ....................................................................................... 41 
8.4 
MONITORING OF PATIENTS WITH ADVERSE EVENTS .................................................................... 42 
8.5 
PREGNANCY ............................................................................................................................. 42 
9 
STATISTICAL CONSIDERATIONS ................................................................... 42 
9.1 
ANALYSIS POPULATIONS (DATA SETS) ...................................................................................... 42 
9.1.1 
Safety Data Set ............................................................................................................. 43 
9.1.2 
Intent to Treat Population ............................................. Error! Bookmark not defined. 
9.1.3 
Per-Protocol Population .............................................................................................. 43 
9.2 
MISSING DATA .......................................................................................................................... 43 
10 
OBLIGATIONS OF THE PRINCIPAL INVESTIGATOR .................................... 43 
10.1 
INVESTIGATOR COMPLIANCE ..................................................................................................... 43 
11 
STUDY MANAGEMENT .................................................................................... 44 
11.1 
INSURANCE .............................................................................................................................. 44 
11.2 
SITE SELECTION ....................................................................................................................... 44 
11.3 
REGULATORY AND ETHICAL REQUIREMENTS ............................................................................. 44 
11.3.1 
Informed Consent ........................................................................................................ 44 
11.3.2 
Study Registration ....................................................................................................... 44 
11.3.3 
Ethics Committee ......................................................................................................... 44 
11.3.4 
Screening Failures ....................................................................................................... 45 
11.3.5 
Early Withdrawal .......................................................................................................... 45 
11.3.6 
Protocol Deviations ..................................................................................................... 45 
11.4 
RECORD MANAGEMENT ............................................................................................................ 47 
11.4.1 
Investigator Records ................................................................................................... 47 
11.4.2 
Source Documents ...................................................................................................... 47 

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11.4.3 
Case Report Forms ...................................................................................................... 47 
11.4.4 
Data Management ........................................................................................................ 47 
11.4.5 
Records/Data Retention .............................................................................................. 48 
11.5 
PATIENT RETENTION AND MINIMIZING LOSS TO FOLLOW-UP ....................................................... 48 
11.6 
MONITORING ............................................................................................................................ 48 
11.6.1 
Study Initiation Visit .................................................................................................... 48 
11.6.2 
Routine Monitoring Visits ........................................................................................... 49 
11.6.3 
Study Closeout Visit .................................................................................................... 50 
11.7 
STUDY TERMINATION OR PREMATURE TERMINATION .................................................................. 50 
11.7.1 
Center Discontinuation ............................................................................................... 50 
11.8 
PROTOCOL AMENDMENTS ......................................................................................................... 51 
12 
PUBLICATION RIGHTS .................................................................................... 51 
13 
PROTOCOL SIGNATURE PAGE ...................................................................... 52 
14 
REFERENCES ................................................................................................... 53 
 
 

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1 
Background and Study Rationale 
In order to improve the safety and success in particular for dental implants with a reduced 
diameter (Ø), Straumann® developed the material Roxolid®. It is alloyed from 2 of the most 
biocompatible materials, titanium and zirconium (Steinemann, 2000). Material specifications 
and dynamic tests have shown improved implant strength (Gottlow et al., 2012 and Kobayashi 
et al., 1995). Furthermore, it features the fast osseointegrating hydrophilic and chemically 
active Sand blasted, Large grit, Acid etched SLActive® surface. Animal studies have shown 
that the SLActive® surface on Roxolid® has comparable osseointegration properties as on pure 
titanium (Gottlow et al., 2012). Combining higher strength with excellent osseointegration 
substantially increases implant safety. Clinical performance of the Roxolid® Ø 3.3 mm implant 
was documented by Al-Nawas et al., 2012, Benic et al., 2013, Al-Nawas et al., 2014 and 
Quirynen et al., 2015. 
Straumann® has developed a novel, 2-piece dental implant based on Roxolid® and SLActive® 
technology with a diameter of 2.9 mm (Straumann® Bone Level Tapered (BLT) implant 
Ø 2.9 mm) to allow treatment of patients with single tooth gaps of small dimensions. This 
implant is indicated for single tooth replacement of the lateral and central incisor positions in 
the mandible and for the maxillary lateral incisors. These positions are reduced-load-bearing 
compared to more posterior positions. One of the rationales for the use of the Straumann® 
BLT implant is the patient’s benefit to decrease the rate of augmentations necessary for 
implant insertion in comparison with standard diameter implants. 
According to the 5th International Team for Implantology (ITI) Consensus Conference 2-piece 
implants with a diameter of 3.0 to 3.25 mm are documented for non-load-bearing single tooth 
gaps (Klein et al., 2014).  
2 
Objectives 
The aim of this study is to provide short-term data on the performance and safety of the 
Straumann® BLT implant Ø 2.9 mm in the clinical practice setting.  
2.1 
Primary Objective 
The primary objective of this post-market clinical follow-up (PMCF) study is to assess implant 
survival at 12 months after implant placement of the Straumann® BLT implant Ø 2.9 mm in the 
usual clinical practice setting in partially healed extraction socket of the central and lateral 
incisors in the mandible and lateral incisors in the maxilla for single tooth replacement. 

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2.2 
Secondary Objectives 
The secondary objectives of the study are to assess the Pink Esthetic Score (PES) at 
6 months after implant placement, the implant success and the marginal bone level changes at 
12 months after implant placement, and the incidence of Adverse Events (AEs) and Adverse 
Device Effects (ADEs). 
3 
Study Design 
3.1 
Type and Design of the Study 
This is a multi-center, prospective, single cohort, PMCF study.  
3.2 
Indications and Contra-Indications 
Straumann® BLT implants Ø 2.9 mm are suitable for the functional and esthetic oral 
rehabilitation of single tooth gaps in Federation Dentaire Internationale (FDI) positions 12, 22, 
31, 32, 41 or 42. Because of their reduced mechanical stability, Straumann® BLT implants 
Ø 2.9 mm are only used in cases with low mechanical load. Placement in posterior regions is 
not recommended. The prosthetic restorations used are single crowns, which are connected to 
the implants by the corresponding elements (Straumann® Variobase® Small CrossFit® (SC) 
abutments).  
The complete details of the Instructions for Use (IfU) for the Straumann® BLT implant 
Ø 2.9 mm can be found in the Annex 1.  
3.3 
Study Treatment 
Straumann® BLT implants Ø 2.9 mm will be placed in at least 40 patients (only 1 implant per 
patient is assessed) within the intended use: central and lateral incisors in the mandible and 
lateral incisors in the maxilla for single tooth replacement followed by prosthetic loading (see 
IfU, Annex 1). When placing the implant, the soft tissue coverage of the socket should be 
complete (Type 2, according to the categorization of Hämmerle et al., 2004), which takes 
typically 4 to 8 weeks after extraction.  
The choice of the implantation procedure and the loading protocol within given time frames 
(Section 6) is the responsibility of the Investigator. The Investigator will decide on the best 
treatment plan for the patient within the description provided in the brochure “Basic Information 
on the Surgical and Prosthetic Procedures for the Straumann® Bone Level Tapered Implants 
Ø 2.9 mm SC” (Annex 2).  
In the brochure “Basic Information on the Surgical and Prosthetic Procedures for the 
Straumann® Bone Level Tapered Implants Ø 2.9 mm SC” (Annex 2), details about the 

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necessary bone volume and the spacing between implants and the distance from adjacent 
teeth can be found. 
3.4 
Endpoints 
3.4.1 Primary Endpoint 
The following parameter will be measured as primary endpoint: 
 
Implant survival at 12 months after implant placement 
3.4.2 Secondary Endpoints 
The following parameters will be measured as secondary endpoints: 
 
PES at 6 months after implant placement 
 
Implant success at 12 months after implant placement 
 
Marginal bone level changes at 12 months after implant placement 
 
AEs and ADEs incidence 
3.5 
Study Sample Size 
The study will enroll at least 40 patients at 5 study centers. Two university hospitals and 
3 private dental practices in Germany will be involved. 
3.6 
Study Duration 
In October 2015, after CE-marking of the Straumann® BLT implant Ø 2.9 mm, it is expected 
that the 1st patient will be enrolled in the study. In December 2017, patient recruitment is 
expected to be complete.  
Treatment phase per patient will be approximately 4 months from surgery to placement of the 
final crown. Each patient will be followed for 12 months after implant placement and data will 
be collected during this time period. The total duration of the study is expected to span 
18 months (2.5 year). Hence, the end of the study is planned to be in December 2018. 
3.7 
Study Population 
The study population will consist of male or female patients, 18 years of age or older, who are 
in need of a single tooth replacement with a dental implant in central and lateral incisors in the 
mandible and lateral incisors in the maxilla, and meet all of the inclusion (Section 3.7.1) but 
none of the exclusion criteria (Section 3.7.2).  

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Patients will be asked to provide informed consent in writing prior to any study related 
procedures (Section Error! Reference source not found.) and will be considered 
“consented” in the study. This will be documented in the Screening and Enrollment Log. 
Patients will be evaluated based on the inclusion and exclusion criteria for initial eligibility 
during the Screening Visit. Patients who provide informed consent and meet the enrollment 
criteria will be invited to enroll into the study. Once the patient receives the Straumann® BLT 
implant Ø 2.9 mm, he/she is considered “enrolled” in the study and the second part of the 
Screening and Enrollment Log will be completed. Patients who are not eligible to receive the 
Straumann® BLT implant Ø 2.9 mm will be considered “screening failures” (Section 11.3.4).  
3.7.1 Inclusion Criteria 
For this study, inclusion criteria are particularly broad and exclusion criteria limited in order to 
document patients’ treatment with Straumann® BLT implants Ø 2.9 mm in usual clinical 
practice.  
The following criteria must be met for inclusion in the study: 
 
Patients must have voluntarily signed the Informed Consent Form before any study related 
procedures are performed, are willing and able to attend scheduled follow-up visits and 
agree that the pseudonymized data will be collected and analyzed. 
 
Patients must be males or females who are a minimum of 18 years of age. 
 
Patients with a minimum of 4 weeks history of edentulism in the study area, minimal 
interdental space and in need of a single tooth replacement with a dental implant central 
and lateral incisors in the mandible and lateral incisors in the maxilla (FDI positions 12, 22, 
31, 32, 41 or 42). 
 
Presence of natural tooth or implants adjacent to the study implant position (single tooth 
gap). 
 
Patients with complete soft tissue coverage of the socket at the Baseline Visit. 
3.7.2 Exclusion Criteria  
Patients matching any contraindication as stated in the IfU (Annex 1) should be excluded: 
 
Patients with inadequate bone volume and / or quality or metabolic bone disorder. 
 
Patients with local root remnants. 
 
Patients with inadequate wound healing capacity. 
 
Patients with not completed maxillary and mandibular growth. 

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 
Patients with serious internal medical problems, uncontrolled bleeding disorders, 
psychoses, prolonged therapy-resistant functional disorders, xerostomia, weakened 
immune system, illnesses requiring periodic use of steroids or uncontrollable endocrine 
disorders. 
 
Patients with poor general state of health. 
 
Patients with drug or alcohol abuse. 
 
Patients with allergies or hypersensitivity to chemical ingredients of titanium-zirconium 
alloy. 
 
Patients 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.  
 
A woman who is pregnant or planning to become pregnant at any point during the study 
duration. 
4 
Device Description and Specifications 
4.1 
Straumann Bone Level Tapered Implant Ø 2.9 mm 
The complete details of the product description and instructions for the Straumann® BLT 
implant Ø 2.9 mm can be found in the “Basic Information on the Surgical and Prosthetic 
Procedures for the Straumann® Bone Level Tapered Implants Ø 2.9 mm SC” (Annex 2) and in 
the IfU (Annex 1). The implants are available with a length of 10, 12 and 14 mm. They are 
designed to be placed at bone level. They are made of a binary titanium-zirconium alloy 
(commercial name Roxolid®) and feature the SLActive® surface, which is a hydrophilic and 
chemically acitive large grit sand blasted and acid etched surface. The chemically activated 
state is preserved by storage in a physiological sodium chloride solution. 
The Straumann® BLT implants Ø 2.9 mm listed in Table 1 will be available for use in this study. 
The clinician may select the appropriate restorative components for the case from any of the 
Straumann® restorative components listed in Table 1. 
 

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Table 1: Description of the Implants and Abutments 
Material 
Roxolid® 
Surface 
SLActive® 
Device model image 
 
 
 
 
 
Straumann® Bone Level Tapered Implant 
Ø 2.9 mm  
Geometry 
Bone Level Tapered 
Endosteal diameter 
2.9 mm  
Internal connection 
Small CrossFit® (SC) 
Implant lengths 
10, 12, 14 mm 
Prosthetic restoration components 
Straumann® Variobase® SmallCrossFit® SC Abutments 
 
4.2 
Product Registration Status 
Straumann® BLT implants Ø 2.9 mm and the corresponding prosthetic components are 
expected to be CE-marked in the second half of 2015 and will only be used within their 
indications. The study will not start until CE-clearance for all components involved has been 
received. 
4.3 
Instructions for Use, Handling and Labeling 
Straumann® will provide the 5 centers with the necessary number of study devices for the 
study. The products delivered for the study are to be used only for the patients enrolled in the 
study and according to the protocol. 
The study device must be used as described in the IfU (Annex 1).  
Device Deficiencies (DDs) shall be reported to Straumann® on the DD eCRF page as 
described in Section 8.3.3 
4.4 
Storage 
The study device should be stored in its original container until used and its access shall be 
controlled.   
4.5 
Device Accountability 
The Investigator must maintain an accurate and up-to-date accountability record of all study 
devices 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. 

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At each monitoring visit, the monitor will check the study 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).  
4.6 
Return of Study Device 
After treatment of the last patient, any remaining unopened study devices at site must be 
returned to Straumann® and acknowledged for receipt. A copy of the acknowledgement of 
receipt must be filed in the Investigator Site File. 
5 
Risk Analysis, Risk/ Benefits 
 
The device risk analysis and risk assessment for the BLT implants was conducted according 
to EN International Organization for Standardization (ISO) 14971 for CE-marked implants. Full 
results are included in the Risk Management Report dated 25 February 2016. 
Refer to Table 6 for a list of potential expected ADEs following the insertion of dental implants. 
Read carefully the risks associated with the study device and the procedures involved in its 
use listed in the IfU (Annex 1) 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 Ncm (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. 
Potential benefits of the placement of the Straumann® BLT implant Ø 2.9 mm may include less 
invasive surgery and reduced need of bone augmentation. 

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6 
Schedule of Assessments 
An overview of the study procedures and evaluations is provided in Table 2. 

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Table 2: Schedule of Assessments 
Category 
Evaluation 
VISIT 1 
VISIT 2 
VISIT 3 
VISIT 4 
VISIT 5 
VISIT 6 
VISIT 7 
Screening  
 
 
(Month -2 to 
Day -1) 
Implant 
Placement 
(Baseline) 
Day 0 
Suture 
Removal 
 
Day 7 to 14 
Provisional 
Crown 
 
6 w (±2 w) 
Final Crown  
 
 
4 m (±1 m) 
Follow-up  
 
 
6 m (±1 m) 
Follow-up  
 
 
12 m (±1 m) 
Consent, 
demographic 
and baseline 
characteristics 
 
Informed consent 
X 
 
 
 
 
 
 
If female, pregnancy test 
X 
 
 
 
 
 
 
Demographics (date of birth, gender, 
ethnic origin) 
X 
 
 
 
 
 
 
 
Smoking status 
X 
 
 
 
 
 
 
Selection 
Patient eligibility 
X 
X 
 
 
 
 
 
Medical/dental 
history 
Medical history 
X 
 
 
 
 
 
 
Dental history / pre-operative planning 
X 
 
 
 
 
 
 
Study 
parameters 
Oral hygiene assessment 
X 
X 
X 
X 
X 
X 
X 
Plaque Index 
 
 
 
 
 
X 
X 
Modified Sulcus Bleeding Index 
X 
 
 
 
X 
X 
X 
Probing Pocket Depth 
 
 
 
 
 
X 
X 
Photograph of the implant site 
X 
X 
X 
X 
X 
X 
X 
 
X-ray 
X1 
X2 
 
 
X2 
 
X2 
 
Implant success criteria 
 
 
 
 
X 
X 
X 
 
Implant survival 
 
 
X 
X 
X 
X 
X 
 
Pink esthetic score 
 
 
 
 
 
X 
X 
Safety 
Adverse events 
 
X 
X 
X 
X 
X 
X 
 
Changes in concomitant medication 
 
X 
X 
X 
X 
X 
X 
Treatment 
Implant placement 
 
X 
 
 
 
 
 
 
Suture removal 
 
 
X 
 
 
 
 
 
Provisional crown 
 
 
 
X 
 
 
 
 
Final crown 
 
 
 
 
X 
 
 
d=day, m=month, w=week. 
1 At screening, this should either be a panoramic radiograph or full mouth Cone-Beam Computed Tomography scan. 
2 At Visits 2, 5 and 7, peri-apical X-rays should be taken. 
 

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6.1 
Visit Windows 
Patients need to be seen within the visit windows as stated in Table 3. 
Table 3: Visit Days and Windows 
Visit # 
Visit Name 
Visit Day and Window 
Visit 1 
Screening 
Up to 2 months before implant placement 
Visit 2 
Implant Placement (Baseline) 
Day 0 
Visit 3 
Suture Removal 
7 to 14 days after implant placement 
Visit 4 
Provisional Crown 
6 weeks ± 2 weeks after implant placement 
Visit 5 
Final Crown 
4 months ± 1 month after implant placement 
Visit 6 
6-month Follow-Up  
6 months ± 1 month after implant placement 
Visit 7 
12-month Follow-Up (Primary Endpoint) 12 months ± 1 month after implant placement 
 
6.2 
Screening Visit (Visit 1) 
At the Screening Visit (up to 2 months before the implant surgery), the Investigator (or 
designee) will review the study with the patient and invite him/her to participate. Once written 
informed consent has been obtained, an initial evaluation will be conducted to determine 
whether the patient meets the study inclusion criteria and not any of the exclusion criteria and 
specified study information will be collected. The following evaluations will be performed and 
documented at the Screening Visit, which are described in details in Section 7. 
 
Before any study procedure starts, written informed consent from each patient has to be 
obtained according to the procedure described in Section Error! Reference source not 
found. 
 
If female, pregnancy test  
 
Demographics  
 
Smoking status  
 
Patient eligibility (inclusion and exclusion criteria) 
 
Medical and dental history / pre-operative planning 
 
Oral hygiene assessment 
 
Modified Sulcus Bleeding Index (mSBI) 
 
Photograph of the implant site 
 
Panoramic radiograph or full mouth Cone-Beam Computed Tomography (CBCT) scan 

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6.3 
Implant Placement (Baseline; Visit 2) 
The inclusion and exclusion criteria should be re-evaluated at the Baseline Visit prior to 
implant placement to confirm eligibility. Straumann® BLT implant Ø 2.9 mm will be placed in 
accordance to the protocol and recommendations given by the manufacturer (see 
Section 3.3), and bone augmentation procedures will be performed, if applicable. Primary 
stability will be assessed by hand testing after implant placement. See Section 7.18 for the 
required documentation regarding the implant placement.  
The following evaluations will be performed and documented at the Baseline Visit, which are 
described in details in Section 7: 
 
Review of the patient eligibility (inclusion and exclusion criteria) 
 
Oral hygiene assessment 
 
Photographs of the implant site 
 
X-ray  
 
AEs 
 
Changes in concomitant medications 
 
Details of implant placement 
6.4 
Suture Removal (Visit 3) 
At Visit 3, sutures will be removed according to the routine of the respective study center and 
Investigator. Usually sutures are removed 7 – 14 days after implant surgery.  
The following evaluations will be performed and documented at Visit 3, which are described in 
details in Section 7: 
 
Oral hygiene assessment 
 
Photograph of the implant site 
 
Implant survival 
 
AEs 
 
Changes in concomitant medications 
 
Suture removal 
6.5 
Provisional Crown (Visit 4) 
At Visit 4, approximately 6 weeks after implant surgery, the gingiva will be re-opened, if 
applicable, and a provisional crown will be placed according to the routine of the respective 

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study center and Investigator. See Section 7.19 for the required documentation regarding the 
placement of the provisional crown. 
The following evaluations will be performed and documented at Visit 4, which are described in 
details in Section 7: 
 
Oral hygiene assessment 
 
Photograph of the implant site 
 
Implant survival 
 
AEs  
 
Changes in concomitant medications 
 
Details of the selected provisional crown 
6.6 
Final Impression (not a scheduled visit) 
The final impression will be taken by the prosthodontist.  
6.7 
Final Crown (Visit 5) 
At Visit 5, approximately 4 months after implant surgery, the final crown will be placed 
according to the routine of the respective study center and Investigator.  
The following evaluations will be performed and documented at Visit 5, which are described in 
details in Section 7: 
 
Oral hygiene assessment 
 
mSBI 
 
Photograph of the implant site 
 
X-ray 
 
Implant success criteria 
 
Implant survival 
 
AEs 
 
Changes in concomitant medications 
 
Details of the final crown 
In case the final crown will be placed by the general dentist, the patient must visit the study 
center after the final crown was placed within the given time window to perform the 
evaluations listed above.  

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6.8 
Follow-Up after 6 Months (Visit 6) 
The following evaluations will be performed at Visit 6, which are described in details in 
Section 7: 
 
Oral hygiene assessment 
 
Plaque Index (PI) 
 
mSBI 
 
Probing Pocket Depth (PPD) 
 
Photograph of the implant site 
 
Implant success criteria 
 
Implant survival 
 
PES  
 
AEs 
 
Changes in concomitant medications 
6.9 
Follow-Up after 12 Months (Visit 7) 
The following evaluations will be performed at Visit 7, which are described in details in 
Section 7: 
 
Oral hygiene assessment 
 
PI 
 
mSBI 
 
PPD 
 
Photograph of the implant site 
 
X-ray  
 
Implant success criteria 
 
Implant survival  
 
PES 
 
AEs 
 
Changes in concomitant medications 

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7 
Study Evaluations 
7.1 
Informed Consent 
It is the responsibility of the Investigator, or an authorized person designated by the 
Investigator to obtain informed consent in writing from each patient participating in this study 
prior to any study related procedures. As part of the informed consent discussion, 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 patients are completely free to refuse to enter the study or 
to withdraw from the study at any time for any reason without prejudice. Ample time must be 
provided for the patient to read and understand the Informed Consent Form and to consider 
participation in the clinical investigation. Patients must read, understand and sign the written 
patient information sheet. The consent form must be personally signed and dated by the 
patient 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 patient. The electronic Case Report Form (eCRF) for this study contains a section 
for documenting informed consent, and this must be completed appropriately. 
The informed consent must be approved by an Ethics Committee (EC) before consenting can 
begin. The Informed Consent Form must be available in the primary language of the patient. It 
is written in accordance with the “Declaration of Helsinki” (as adopted by the 18th World 
Medical Assembly, 1964, and as revised in Tokyo (1975), Venice (1983), Hong Kong (1989), 
Somerset West (1996), Edinburgh (2000), Seoul (2008), and Fortaleza (2013) (WMA General 
Assembly, 2013)) and applicable local regulations. 
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 patients should be 
informed of the new information and be given a copy of the revised form. The patients must 
give their consent to continue the study, unless the patient was considered a screening failure 
(see Section 11.3.4). 
7.2 
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 Visit 1, before the study required radiographs are taken, to confirm that the 
woman is not pregnant. The test result must be documented in the source data. A woman who 

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is pregnant or planning to become pregnant at any point during the study duration cannot be 
enrolled in this study. 
If a woman becomes pregnant during the study, an AE form should be completed. The woman 
should be followed for the duration of the pregnancy, without the study required peri-apical 
radiographs, and the outcome of the pregnancy should be documented (Section 8.5). 
7.3 
Demographics  
Patient demographics (date of birth, gender and ethnic origin) need to be documented at 
screening (Table 2).  
7.4 
Smoking Status 
Smoking status need to be documented at screening (Table 2). It will be assessed if patients 
are current or past smokers and they will be classified into: 
 
Non-smokers 
 
Light smokers: 1 to ≤ 10 cigarettes per day 
 
Heavy smokers: > 10 cigarettes per day 
7.5 
Inclusion and Exclusion Criteria 
At screening, the inclusion and exclusion criteria will be evaluated according to Sections 3.7.1 
and 3.7.2, and will be re-evaluated at baseline. Patients must fulfill all of the inclusion criteria 
and must not meet any of the exclusion criteria to be eligible for enrollment in the study.  
7.6 
Medical and Dental History / Pre-Operative Planning 
Medical and dental history / pre-operative planning will be obtained at the Screening Visit 
(Table 2). Relevant medical history (e.g., systemic diseases) and current medical conditions 
will be evaluated by the Investigator based on the information available. The information may 
be obtained from the patient’s general physician or from oral communication with the patient. 
Dental history / pre-operative planning should include position of the missing tooth, description 
of tooth loss, description of the adjacent dentition, prosthetic history and details of bone 
augmentation procedures if applicable.  
7.7 
Oral Hygiene Assessment 
The patient’s overall oral hygiene will be evaluated at each study visit (Table 2) starting with 
the Screening Visit by choosing one of the following: “excellent”, “good”, “fair” or “poor”. 

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7.8 
Plaque Index 
Plaque Index will be assessed at the time points listed in the schedule of assessment (Table 
2).  
It will be evaluated on the mesial, buccal, distal and palatal surfaces of the implant site using 
the four-point scale PI developed by Silness and Loe (Silness and Loe 1964):  
 
Score 0 – no plaque. 
 
Score 1 –  a film of plaque adhering to the free gingival margin and adjacent area of the 
tooth. The plaque may be seen in situ only after application of disclosing solution or by 
using the probe on the tooth surface. 
 
Score 2 – moderate accumulation of soft deposits within the gingival pocket, or the tooth 
and gingival margin which can be seen with the naked eye. 
 
Score 3 – abundance of soft matter within the gingival pocket and/or on the tooth and 
gingival margin. 
7.9 
Modified Sulcus Bleeding Index 
Modified Sulcus Bleeding Index will be assessed at the time points listed in the schedule of 
assessment (Table 2).  
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 implant site at 4 locations (mesial, buccal, distal, palatal) and 
assessed using the mSBI by Mombelli (Mombelli et al. 1987): 
 
Score 0 – no bleeding when a periodontal probe is passed along the gingival margin.  
 
Score 1 – isolated bleeding spot visible. 
 
Score 2 – blood forms a confluent red line on margin. 
 
Score 3 – heavy or profuse bleeding. 
7.10 Probing Pocket Depth 
Probing Pocket Depth will be assessed at the time points listed in the schedule of assessment 
(Table 2).  
The PPD will be measured at the implant site by recording the distance in millimeters from the 
gingival margin to the bottom of the probable pocket at 4 locations (mesial, buccal, distal, 
palatal). 

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7.11 Photograph of the implant site 
Digital intra-oral photographs should be taken at each study visit (Table 2): 
 
Visit 1 
 
Visit 2:  
o After surgical flap 
o After implant bed preparation 
o After implant insertion (photograph should include augmentation, if applicable) 
o When surgery is completed 
 
Visit 3 
 
Visit 4:  
o Before re-opening 
o After re-opening 
 
Visit 5: 
o Before insertion of the final crown (after the provisional one was removed) 
o After insertion of the final crown 
 
Visit 6 
 
Visit 7 
7.12 Panoramic Radiograph or Cone-Beam Computed Tomography Scan 
A panoramic radiograph or full mouth CBCT scan must be available at the Screening Visit 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 (Table 2). 
7.12.1 Bone Level Changes 
Peri-apical X-rays are standard procedures during implant surgery to assess changes of the 
bone level. Peri-apical X-rays will be taken at baseline (Visit 2), at placement of the final crown 
(Visit 5) and at the end of the study (Visit 7) to assess bone level changes between implant 
placement (Baseline Visit) and placement of the final crown (Visit 5) as well as between 
implant placement and the 12-month Follow-Up Visit (Visit 7) (Table 2).  

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An independent expert will be contracted to perform the bone level measurements from the 
X-rays. The vertical bone level will be evaluated by measuring the distance from the implant 
shoulder to the first visible bone contact on the implant. Measurements will be taken at the 
mesial and distal aspects of the implant, and an average value will be calculated. Mean bone 
level changes will be computed by subtracting the average bone level at Visit 5 from the 
average bone level at baseline (implant placement) and by subtracting the average bone level 
at the 12-month Follow-Up Visit (Visit 7) from the average bone level at baseline (implant 
placement). Hence, negative bone level changes are representing bone loss between baseline 
and Visit 5 and between baseline and the 12-month Follow-Up Visit, respectively; vice versa 
positive changes representing bone gain. Measurements will take into account distortion 
based on changes on the radiograph from the true dimension of the implant.  
7.13 Implant Success Criteria 
Implant success will be assessed at the time points listed in the schedule of assessment 
(Table 2).  
A “successful implant” is an implant where all of the following success criteria (according to 
Buser et al., 1990) apply: 
1. Absence of persisting subjective discomfort such as pain, foreign body perception and/or 
dysesthesia (painful sensation); 
2. Absence of recurrent peri-implant infection with suppuration; 
3. Absence of tactile implant mobility; 
4. Absence of a continuous peri-implant radiolucency. 
Failed implants will be counted as not successful. 
7.14 Implant Survival 
Implant survival will be assessed at the time points listed in the schedule of assessment (Table 
2).  
 A ”surviving implant” is an implant stably inserted in the jaw. Note, that a surviving implant 
may not be successful if the success criteria (see Section 7.13) are not fulfilled. 
A ”failed implant” is an implant that: 
 
Has been removed; or 
 
Has fractured beyond repair. 

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7.15 Pink Esthetic Score 
PES will be assessed by the Investigator at the time points listed in the schedule of 
assessment (Table 2). The PES score allows an objective evaluation of peri-implant soft tissue 
of single tooth implants based on 7 parameters (Table 4 and Figure 1) and is highly 
reproducible. Each variable will be assessed using a 0-1-2 scoring system; 0 being the lowest, 
and 2 being the highest value. The maximum achievable PES is 14 (Fürhauser et al., 2005). 
Table 4: Pink Esthetic Score Variables 
 
 
Figure 1: Visualization of the Pink Esthetic Score Variables  
 
 
 
 
 
 
 
 
Refer to Table 4 for description of the variables.  
 

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7.16 Adverse Events 
At each visit the Investigator should determine if any AEs occurred since the last study visit by 
speaking with the patient and reviewing any dental and medical records. These AEs, along 
with any AEs from the current study visit, should be documented and reported as described in 
Section 8 of the protocol. In addition the Investigator should evaluate the status of any ongoing 
AEs throughout the study as specified in Section 8.4. 
7.17 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. Prophylactic 
antibiotics and anesthesia given do not need to be recorded on the Concomitant Medication 
eCRF page as long as they are taken by the patients in the same or lower dosage as during 
standard treatment during the following procedures: 
 
Visit 2: Implant placement 
 
Visit 3: Suture removal 
 
Visit 4: Placing of the provisional crown 
 
Visit 5: Placing of the final crown. 
7.18 Details of Implant Placement 
At the Baseline Visit, the implant placement procedure needs to be documented as follows 
(Table 2): 
 
Time since tooth was lost or removed (note, soft tissue coverage of the socket should be 
complete at baseline; i.e., Type 2 according to the categorization of Hämmerle et al., 
2004); 
 
Type of healing procedure (subgingival or transgingival) and if soft tissue transplant was 
required; 
 
Bone quality according to the 4 different bone types described by Lekholm et al., 1985; 
 
Implant length; 
 
Details of the surgery (including site of implant placed); 
 
Details of augmentation procedures (e.g., bone graft used); 
 
Torque measurements if applicable; 

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 
Stability of the implant after placement. The implant can be considered as primary stable 
or instable. 
7.19 Provisional Crown Description 
Details of the selected provisional need to be documented at Visit 4 (Table 2): 
 
Material of the provisional crown; 
 
If the provisional crown was loaded in occlusion, 
 
If soft tissue graft was used. 
7.20 Final Crown Description 
Details of the final crown need to be documented at Visit 5 (Table 2): 
 
Material of the final crown; 
 
If the final abutment was torqued to 35 Ncm with no rotational movement of the implant. 
8 
Evaluation of Adverse Events and Device Deficiency 
8.1 
Definition 
A summary of the classification for AEs is provided in Table 5. 
Table 5: Summary of the Classification for Adverse Events 
Adverse 
events 
Non-device related 
Device or procedure related 
Non-
serious 
Adverse Event (AE) 
Adverse Device Effect (ADE) 
Serious 
Serious Adverse Event 
(SAE) 
Serious Adverse Device Effect (SADE) 
Anticipated 
Unanticipated 
Anticipated Serious 
Adverse Device 
Effect (ASADE) 
Unanticipated 
Serious Adverse 
Device Effect 
(USADE) 
 
8.1.1 Adverse Event 
An AE is defined as any untoward medical occurrence, unintended disease or injury, or any 
untoward clinical signs (including abnormal laboratory findings) in patients, users or other 
persons, whether or not related to the study device. This definition includes events related to 
the study device, or events related to the procedures involved. For users or other persons, this 

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definition is restricted to events related to study devices. Disease signs and symptoms already 
existing prior to the use of the study devices are not considered as AE unless they re-occur 
after the patient has recovered from the preexisting condition, or represent an exacerbation in 
intensity or frequency. 
8.1.2 Serious Adverse Event  
An AE should be classified as serious if it meets any of the following criteria: 
 
Led to a death; 
 
Led to a serious deterioration in the health of the patient, 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 
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.  
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 (SAE). 
This includes DDs that might have led to an SAE if 
 
suitable action had not been taken, or 
 
intervention had not been made, or 
 
if circumstances had been less fortunate. 
These are handled under the SAE reporting system. 
8.1.3 Device Deficiency  
A DD is an inadequacy of a medical device with respect to its identity, quality, durability, 
reliability, safety or performance. DD include malfunctions, use errors and inadequate labeling. 
Device Deficiencies can be classified into: 
 
DDs with Serious Adverse Device Effect (SADE) potential 
 
DDs without SADE potential. 
A DD does not always lead to an AE. In addition, only DDs related to the study device need to 
be tracked by Clinical Research Team. 

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8.1.4 Adverse Device Effect  
An ADE is an AE related to the use of a study device or procedure (e.g., surgery). This 
definition includes AEs resulting from insufficient or inadequate IfU, deployment, implantation, 
installation, or operation, or any malfunction of the study device. This definition includes any 
event resulting from use error or from intentional misuse of the study device. Any AE which the 
Investigator believes has even a possible relationship to the device will be classified as an 
ADE. 
8.1.5 Serious Adverse Device Effect  
A SADE is an ADE that has resulted in any of the consequences characteristic of a SAE (see 
Section 8.1.2). 
8.1.6 Unanticipated Serious Adverse Device Effect  
An Unanticipated Serious Adverse Device Effect (USADE) is a SADE which by its nature, 
incidence, severity or outcome has not been identified in the current version of the Risk 
Management Report or IfU (Annex 1). 
8.1.7 Anticipated Serious Adverse Device Effect 
An Anticipated Serious Adverse Device Effect (ASADE) is an SADE which by its nature, 
incidence, severity or outcome has been identified in the Risk Management Report or IfU 
(Annex 1). 
8.2 
Assessment of Adverse Events 
If an AE occurs, 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 AE should be assessed by the Investigator for seriousness, relationship to the study 
device or the procedure, severity, expectedness and outcome as described in Sections 8.2.1 
to 8.2.5. The rationale for each assessment must be described as well in a short paragraph 
and source documents should support the designation. To do so, the Investigator reviews 
systematically all available documentation (e.g., hospital notes, X-rays, laboratory and 
diagnostic reports) relevant to the event and investigates its cause. 
8.2.1 Seriousness 
An AE will be described as serious if it meets the definition in Section 8.1.2. 

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8.2.2 Relationship to the Study Device or Procedure 
It is useful to analyze an AE in accordance with the time of its occurrence and the surgery date 
(i.e., during the implantation period of the device, application, or attempt of placement). 
8.2.2.1 Relationship to the Study Device 
The Investigator will make an assessment of whether the AE is likely to be related to the 
device according to the following definitions: 
 
Definitely Related – there is a reasonable causal and temporal relationship between the 
study device and the AE. 
 
Possibly Related – the nature of the event or temporal relationship make it possible that 
the AE has a causal relationship to the device. 
 
Not Related – no obvious relationship between the study device and the AE. 
8.2.2.2 Relationship to the Procedure 
The Investigator should assess the relationship of the AE to the implant procedure (e.g., 
placement of dental implant). The relationship should be assessed using the categories 
described in Section 8.2.2.1. 
8.2.3 Severity 
Each AE should be assessed by the Investigator for its severity, or the intensity of an event 
experienced by a patient, according to the following categories: 
 
Mild – events are usually transient, requiring no special treatment, and do not interfere 
with the patient’s daily activities. 
 
Moderate – events that introduce a low level of inconvenience or concern to the patient 
and may interfere with daily activities, but are usually ameliorated by simple therapeutic 
measures 
 
Severe – events interrupt a patient’s usual daily activity and traditionally require systemic 
drug therapy or other treatment. 
The term “severe” used to describe the intensity of an event should not be confused with the 
term “serious”, as defined in Section 8.1.2. 
8.2.4 Expectedness 
If the AE is judged to be related to the study device or procedure, i.e., is an ADE, the 
Investigator will make an assessment of expectedness, or anticipation, based on knowledge of 
the reaction and any relevant product information as documented in the IfU (Annex 1) or in the 

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list of potential expected ADEs in the current protocol (Table 6) following the insertion of dental 
implants. The event will be classed as either: 
 
Expected – the reaction is consistent with the effects of the device listed in the IfU 
(Annex 1) or list of potential expected ADEs in the current protocol (Table 6) following the 
insertion of dental implants. 
 
Unexpected – the reaction is not consistent with the effects listed in the IfU (Annex 1) or 
list of potential expected ADEs in the current protocol (Table 6) following the insertion of 
dental implants. 
Table 6: List of Potential Expected Adverse Device Effects Following the Insertion of 
Dental Implants 
Biological complications 
Peri-implant mucositis 
 
Bleeding (bleeding on probing) 
 
Bruising 
 
Mucosal/gingival inflammation (=gingivitis/mucositis, inflammation of the gum 
tissue)/redness 
 
Gingival enlargement (=gingival hyperplasia, gingival hypertrophy, gum overgrowth, 
hypertrophic gingivitis) 
 
Gingival recession (=dehiscence of the gingiva, receding gums) 
 
Pain (discomfort) 
 
Suppuration 
 
Swelling 
Peri-implantitis 
 
Bleeding (bleeding on probing) 
 
Bone loss around implant (=peri-implant bone loss) 
 
Bruising 
 
Infection at implant site without suppuration  
 
Infection at implant site with suppuration (=peri-implant abscess) 
 
Systemic infection 
 
Pain 
 
Swelling 
Bone integration deficiency 
 
No primary stability (at surgery) 
 
Implant mobility (tactile horizontal or vertical) 
 
Early loss/failure of implant (i.e. before osseointegration) (=primary implant failure) 
 
Late loss/failure of implant (i.e. after osseointegration) (=secondary implant failure) 
 
Radiolucency 
 
Aspiration of implant 
 
Swallowing of implant 

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Non-plaque related 
 
Foreign body sensation 
 
Material allergy 
 
Oro-sinus or oro-nasal intrusion/fistula 
 
Permanent paresthesia/dysesthesia 
 
Temporary or permanent nerve damage in the jaw 
Mechanical complications 
 
Loosening of abutment or prosthetic screw 
 
Loosening of an healing cap 
 
Loss/failure of an abutment 
 
Loss/failure of an healing cap 
 
Fracture of abutment or prosthetic screw 
 
Fracture of implant 
Technical complications 
 
Fracture of prosthesis or veneer 
 
Irreversible damage to adjacent/opposing teeth 
 
Loss of cement retention of prosthesis 
Other complications 
 
Esthetic problem 
 
Aspiration of component(s) (other than implant) 
 
Jaw, bone fracture 
 
Phonetic difficulties 
 
Swallowing of component(s) (other than implant) 
 
Hypersensitivity (adjacent teeth) 
 
8.2.5 Outcome 
The outcome should reflect the status of the AE at the moment of recording. 
 
Resolved without Sequelae – the patient fully recovered from the event without any 
sequelae. This option also applies when it is unknown whether there are sequelae. 
 
Resolved with Sequelae – the patient’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 patient 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 event increased. 

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 
Fatal – the event is related to a death; whether it caused death or contributed to it. If the 
patient died of a different cause, prior to resolution of the event, the outcome of this event 
should designated “ongoing”, and not “fatal”, and an end date should not be specified. 
 
Unknown – knowledge of the current status of the event is truly not available to the 
Investigator (i.e., event was ongoing at last observation, but no further contact with the 
patient could be established). However, all efforts should be made to determine the 
outcome of any event, especially that of an SAE/SADE. 
8.3 
Procedure for Reporting Adverse Events and Device Deficiencies 
Adverse Event reporting will begin at the start of implant placement at the Baseline Visit until 
the last protocol-specific procedure of a patient. All AE/SAEs should be collected, fully 
investigated and documented in the source document and appropriate eCRF pages for all 
patients. In the eCRF, only 1 AE/SAE eCRF entry should be completed per event. To ensure 
patient confidentiality, the reports in Sections 8.3.1 to 8.3.6 will include the patient number 
only.  
The report sequence “initial” shall be ticked on the eCRF page for the initial AE report. In order 
to capture the new information, the AE eCRF page shall be updated and the report sequence 
“follow-up” or “final” shall be ticked as appropriate. 
Adverse Events like swelling, pain or bleeding do not need to be captured on the eCRF page 
as long as they occur in the same or milder intensity as during standard treatment during the 
following procedures: 
 
Visit 2: implant placement 
 
Visit 3: suture removal 
 
Visit 4: Placing of the provisional crown 
 
Visit 5: Placing of the final crown 
8.3.1 Adverse Event Reporting 
In the occurrence of an AE, the AE eCRF page should be completed in a timely manner. 
Safety reporting to the local EC should occur according to the requirements of the EC (see 
Section 11.3.3). 
8.3.2 Serious Adverse Event Reporting 
In the occurrence of a SAE, expedited reporting requirements are followed. The AE eCRF 
page should be completed within 24 h of awareness of the event. The Investigator needs to 
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an SAE/SADE Report Form needs to be completed for each event and sent to the sponsor 
within 24 h of awareness of the event: 
Contact address: 
Clinical Research, Institut Straumann AG  
Phone: +41 61 965 11 11 
Fax: +41 61 965 11 10  
Email: ClinicalResearch@straumann.com 
Safety reporting to the local EC should occur according to the local requirements (see 
Section 11.3.3).  
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. 
8.3.3 Device Deficiency Reporting 
In the occurrence of a DD, the DD eCRF page should be completed in a timely manner. When 
a DD leads to a potential AE (e.g., bleeding, pain, swelling, infection, peri-implantitis) the AE 
eCRF page needs to be completed in a timely manner as well. Moreover, DD with SADE 
potential (e.g., nerve encroachment, sinus perforation, etc.) must be recorded on the AE eCRF 
page, follow the expedited reporting requirements (within 24 h) and the Investigator needs to 
follow-up until resolution. In case of a break-down of the eCRF system, an SAE/SADE Report 
Form needs to be completed for each event and sent to the sponsor within 24 h of awareness 
of the event: 
Contact address: 
Clinical Research, Institut Straumann AG  
Phone: +41 61 965 11 11 
Fax: +41 61 965 11 10  
Email: ClinicalResearch@straumann.com 
8.3.4 Adverse Device Effects Reporting 
Adverse Device Effects must be recorded by completing the AE eCRF page in a timely 
manner. The Investigator needs to follow-up on all ongoing ADEs until resolution. Safety 
reporting to the EC should occur according to the local requirements (see Section 11.3.3). 
Continuous substantial reduction of the peri-implant bone level is a sign of failure of the 
implant system. The 1st European Workshop on Periodontology specified an average marginal 

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bone loss of less than 1.5 mm bone loss within the 1st year after the insertion of the prosthesis, 
and thereafter less than 0.2 mm annual bone loss as criteria for measuring success 
(Albrektsson et al., 1993). 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% CI -0.661 to -0.481) after 5 years. The individual 
study means of marginal bone level change ranged from -1.0 to -0.15 mm after 5 years 
(Laurell L et al., 2011). Based on this information the central radiologist will flag any bone level 
changes that are greater than 2.0 mm in the 1st year after insertion of the prosthesis. 
8.3.5 Serious Adverse Device Effect Reporting 
In the occurrence of a SADE, expedited reporting requirements are followed. The AE eCRF 
page should be completed within 24 h of awareness of the event. The Investigator needs to 
follow-up on all ongoing SADEs until resolution. In case of a break-down of the eCRF system, 
an SAE/SADE Report Form needs to be completed for each event and sent to the sponsor 
within 24 h of awareness of the event: 
Contact address: 
Clinical Research, Institut Straumann AG  
Phone: +41 61 965 11 11 
Fax: +41 61 965 11 10  
Email: ClinicalResearch@straumann.com 
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 EC as soon as possible, but no later than 
10 working days after 1st learning of the event. 
Since this is a multi-center study, Straumann will inform the 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 EC for review and a copy must be kept in 
the Investigator Site Files. 
8.3.6 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 
patients, or the integrity of the study. Such reports may include notification of any changes to 
the IfU (Annex 1), any publications or interim reports, or any product recalls.  

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8.4 
Monitoring of Patients 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 devices. 
The outcome of an event will be pursued until resolution or until the last data queries are 
issued following the patient’s last study visit. For screening failures, ongoing AEs, ADEs and 
DDs must be followed and updated until the date the patient is deemed a screening failure. 
For patient documented as lost to follow-up, ongoing AEs, ADEs, and DDs 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. 
8.5 
Pregnancy 
If a female patient becomes pregnant during the course of the study, the study visits should be 
completed as scheduled. Any study assessments that could potentially interfere with the 
pregnancy should be avoided until after the pregnancy (e.g., radiographs, etc.). The 
pregnancy should be recorded as an AE, whereas the start of pregnancy will be recorded as 
the start date of the AE and the date of child birth will be recorded as the end date. 
Furthermore, the outcome of the pregnancy should be documented.  
9 
Statistical Considerations 
A qualified statistician will perform all statistical analyses. 
Since the purpose of this study is descriptive, there are no formal sample size calculations 
based on comparative hypothesis testing. Statistical analyses will be descriptive (e.g., 
reporting means, standard deviations, medians, minima, and maxima for continuous variables 
and patient counts, frequencies and percentages for categorical variables). 
The primary analysis will be conducted after all patients completed the 12-month Follow-Up 
Visit. Baseline is implant placement. 
9.1 
Analysis populations (Data Sets) 
The following analysis sets are planned for this study: 

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9.1.1 Safety Data Set  
The safety analysis set (SAS) consists of all patients in the study, who received the study 
implant. The SAS population will be the basis for the safety analysis.  
9.1.2 Full analysis set 
The full analysis set (FAS) consists of all patients in the study, who received the study implant 
and from whom at least one follow-up measurement after baseline is available. This analysis 
will include patients regardless of any protocol deviations and/or premature termination. The 
primary analysis will be performed by the intent-to-treat principle with the FAS.   
9.1.3 Per-Protocol set 
The per-protocol set (PPS) consists of all patients in the study, who received the study implant 
according to the study protocol, completed the study (Visit 1 to Visit 7) and the measurements 
of the primary variable is available. Patients with major protocol deviations (e.g. deviations 
from inclusion/exclusion criteria) will be excluded from this population. The primary and 
secondary analyses will be performed with the PPS as supportive analysis. 
9.2 
Missing Data 
Every effort will be made to minimize the amount of missing data. If a patient drops out of the 
study prior to completing his/her primary endpoint assessment, the Investigator (or designee) 
will attempt to call the patient and to collect the information as detailed in Section 11.5. 
10 Obligations of the Principal Investigator 
10.1 Investigator Compliance 
The Investigators must work according to standard ethical practice as laid down by their 
professional body and insert the product according to what is described in the handling 
procedures and the IfU for the products investigated in this clinical study. In addition, they 
must work in accordance with the “Declaration of Helsinki” (last revision Fortaleza 2013, WMA 
General Assembly, 2013), the ISO 14155:2011, Good Clinical Practice (GCP) and with local 
legal and regulatory requirements. 
The Investigators will ensure that the study is conducted in compliance with this protocol and 
the Clinical Study Agreement. Specifically, they are also responsible of conducting the 
informed consent process (Section Error! Reference source not found.). 

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11 Study Management 
11.1 Insurance 
As only CE-marked products are investigated, the product liability insurance applies.  
11.2 Site Selection 
The sites were selected by assessing e.g., training and experience of the site staff, site 
equipment, patient pool and expected recruitment period. 
11.3 Regulatory and Ethical Requirements 
11.3.1  Informed Consent 
Informed consent will be obtained from all patients prior to study participation as described in 
Section Error! Reference source not found.. 
11.3.2 Study Registration 
This protocol will be registered at clinicaltrials.gov at the study start. 
11.3.3 Ethics Committee 
Prior to initiation of any study procedures, the protocol and informed consent will be submitted 
to the EC at each site for review and approval. In addition, any amendments to the protocol or 
informed consent will be reviewed and approved (if necessary) by the EC. The sponsor must 
receive a letter documenting the EC approval at the center prior to the initiation of the study at 
the center. The study will not begin until the required approval from the EC has been obtained. 
Any additional requirements imposed by the EC shall be followed. 
The Investigator is responsible for providing the appropriate reports to the EC during the 
course of the clinical study. This will include the following: 
 
Informing the EC of the study progress periodically as required, but at a minimum annually. 
 
Reporting any unanticipated SADEs within 10 working days of becoming aware of the 
event. 
 
Reporting any major deviations from the protocol that adversely affects the risk/benefit 
ratio, the rights, safety, or welfare of the participants, or integrity of the study as requested 
by the EC.  
 
Providing any other reports requested by the EC. 

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11.3.4 Screening Failures 
Any patient that has signed the Informed Consent Form and does not receive the study device 
is considered a screening failure. In the event of a screening failure, the eCRF page should be 
completed up to the visit when the patient was determined to be a screening failure. The Study 
Termination eCRF page should also be completed. 
11.3.5 Early Withdrawal 
Any patient may withdraw from the study any time without prejudice and will be offered an 
alternative treatment related to their dental condition. Patients will be advised of the need for 
the prescribed follow-up visits for their ongoing care and well-being.  
The Investigator may withdraw any patient from the study in the case of: 
 
Non-compliance with the protocol 
 
Failure to attend the follow-up visits 
 
SAE or AE, which in the opinion of the Investigator prevents the patient’s further 
participation in the study. 
The Investigator must withdraw any patient from the study in the case of: 
 
Implant loss 
The patient withdrawal will be documented on a Study Termination eCRF page and must 
include the reason for the patient withdrawal. Withdrawn patients will not be replaced and 
cannot be re-enrolled. 
11.3.6 Protocol Deviations 
Protocol deviations are to be avoided. Any deviation from the protocol (including deviations 
from the expected study visit windows) may jeopardize the study outcome. Non-compliance of 
the patients, as well as of the Investigators, may lead to the closure of the respective study 
center.  
11.3.6.1 Definitions 
A protocol deviation is any non-compliance with the clinical study protocol, GCP, or Manual of 
Procedures (e.g., the brochure “Basic Information on the Surgical and Prosthetic Procedures 
for the Straumann® Bone Level Tapered Implants Ø 2.9 mm SC” (Annex 2)) requirements. The 
non-compliance may be on the part of the patient, the Investigator or study staff.  Protocol 
deviations are categorized as: 

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a) 
Major protocol deviation that in the Investigator’s judgment: 
o Increases risk to one or more participants; 
o Adversely affects the safety, rights or welfare of one or more participants; or 
o Adversely affects the integrity of the study. 
Examples of major protocol deviations include: Informed consent obtained after the 
initiation of study procedures, omitting study procedure(s) required by approved 
protocol, failure to report a SAE, enrolling participants outside of inclusion criteria. 
b) 
Minor protocol deviation is a contravention of the protocol that does not impact 
participant’s safety, nor compromises the integrity of the study data, neither/nor ethics of the 
study. Note: Several minor observations may collectively be considered as equal to a major 
protocol deviation. 
Example: Insignificant delay in performing study procedure (i.e., minor window 
deviation). 
11.3.6.2 Procedure 
If a protocol deviation has occurred, the following procedure shall be followed: 
 
Recording:  
o All major deviations from the protocol must be recorded on the Protocol Deviation 
eCRF page.  
 
Reporting:  
o All major protocol deviations that occur at site shall be immediately notified to the 
sponsor and promptly reported to the local EC according to their requirements (see 
Section 11.3.3).  
o Minor protocol deviations shall normally not be reported to the EC.  
Any documentation relating to protocol deviation will be filed in the Investigator Site File. 
In case of prospective protocol deviation, the Protocol Waiver/Exception Request Form shall 
be completed by the Investigator and submitted to the sponsor for agreement and to the EC 
for review and approval. The Investigator should not implement any deviation from, or changes 
of, the protocol without agreement from the sponsor, and documented approval/favourable 
opinion of the EC, if relevant. 

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11.4 Record Management 
11.4.1 Investigator Records 
The following will be required from the Investigator prior to the initiation of the study: 
 
A signed Confidentiality Agreement 
 
Signed and dated curriculum vitae of the Investigator(s) and a copy of his/her dental 
license 
 
Signed financial disclosure of the Investigator(s) 
 
A signed copy of the final protocol and any amendments 
 
A signed copy of the Clinical Study Agreement with the sponsor 
 
EC approval letter and EC approved informed consent document 
11.4.2 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 audit or 
inspection by authorized persons. 
11.4.3 Case Report Forms 
Required clinical data for this study will be collected using an eCRF for all study patients from 
whom informed consent is obtained. Site numbers and patient numbers will be used to track 
patient information throughout the registry.  
The Principal Investigator or authorized designee is responsible for the timely and accurate 
completion of all eCRFs from source documents, query resolution and signature of all eCRFs. 
The Investigator will also allow a Straumann representative and/or regulatory bodies to review 
the data reported on the eCRF with the source documents as far as is permitted by local 
regulations.  
11.4.4 Data Management  
Data will be collected through an Electronic Data Capturing (EDC) system provided to the 
centers prior to study start. Automatic queries will be built into the system prior to study start 
and throughout the project. The site will enter study data into the electronic database as soon 
as possible after the patient visit. Data capture will be source verified by the monitor and 
reviewed by the Data Manager. For any missing, out of range or questionable data, an 

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electronic query will be generated and sent to the Investigator for completion. The Investigator 
answers the query, which will be documented.  
Once all patients have completed the study and all queries are answered, the database will be 
frozen and the statistical analysis will start. 
Patient confidentiality will be strictly maintained. 
Details of the data management procedures can be found in the Data Management Plan.  
11.4.5 Records/Data Retention 
Original radiographs, photographs and study documents will be maintained at the study center 
in a file established for this study. All study documentation from the site needs to be stored at 
the study center for a period according to the applicable local regulatory and legal 
requirements after 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 for 20 years at Straumann according to 
Straumann’s Standard Operating Procedures (SOP).  
11.5 
Patient Retention and Minimizing Loss to Follow-Up 
If a patient does not return for any scheduled visits, the Investigator (or designee) will attempt 
to call the patient and reschedule the office appointment or document the patient’s reason for 
not returning.  
During the phone call, if the patient indicates that he/she no longer wishes to be in the study, 
information will be collected on reason for study withdrawal (e.g., lack of interest, moving, 
switching of dentist, AEs). 
11.6 Monitoring 
Straumann will assign a qualified individual to monitor the study.  
11.6.1 Study Initiation Visit 
Once a site receives EC approval, Straumann’s representative 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. Straumann’s representative 
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). 

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 
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 IfU (Annex 1), 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 EC review and approval of the protocol 
and informed consent, and to ensure continuing review of the study by the EC. 
 
Has adequate facilities and access to an adequate number of suitable patients to conduct 
the study. 
11.6.2 Routine Monitoring Visits 
Monitoring visits will be scheduled and conducted periodically. Straumann or its delegates 
monitors will provide clinical monitoring, including review of eCRFs with verification to the 
source documentation per the Monitoring Plan outlined for the study. 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.  
The following will be reviewed during every monitoring visit: 
 
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. 
 
The study is in compliance with GCP and ISO 14155:2011 and with the applicable 
regulatory requirements (for details see Section 10.1). 
 
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 eCRFs are accurate, complete and verifiable from 
source documents. 
 
All AEs (including SAEs) are reported correctly. In cases where there is missing 
information about an AE or missing evidence to support the Investigator’s assessment, a 
monitor will review and discuss the AE with the responsible Investigator. 

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 
The reason for a patient’s withdrawal has been documented. 
11.6.3 Study Closeout Visit 
After the last patient 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’s representative or the monitor: 
 
Ensure that the documentation and clinical investigation requirements were met. 
 
Collect outstanding documents. 
 
Ensure that AEs were reported to the EC according to the EC’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 (see Section 11.4.5). 
11.7 Study Termination or Premature Termination 
At study termination, a clinical study report will be prepared by the sponsor, even if the study 
was terminated prematurely. The report will contain a summary of the study results and made 
available to the participating Investigators. 
The study can be terminated earlier at the discretion of the Investigator or the sponsor in the 
case of any of the following: 
 
Occurrence of ADEs unknown at the start of the study with respect to their nature, severity, 
and duration, or the unexpected excessive incidence of known ADEs. 
 
New scientific knowledge obtained after the start of the study showing the ethical claim of 
the study is no longer valid. 
Patients will be advised of the need for follow-up visits for their ongoing care and well-being. 
11.7.1 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 patients or is unlikely to recruit a 
sufficient number of patients. 
 
The center does not respond to study management requests. 
 
Repeated major protocol deviations have been discovered that affect the integrity of the 
study or the study data. 

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11.8 Protocol Amendments 
Once the first patient 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 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 
Investigators and the sponsor have accepted the changes, a written amendment to the 
protocol will be sent to the Investigators for signature. 
All significant protocol changes affecting the scientific soundness of the study or the rights, 
safety, or welfare of patients which occur after the initial EC approval, must be submitted for 
approval by each center to the EC 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 EC 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. 
12 Publication Rights 
The Coordinating Investigator will be the corresponding author of a scientific publication. 
Analysis of data will be done by the data management. The final manuscript will be prepared 
by the Coordinating Investigator in conjunction with the Institut Straumann AG. The University 
Mainz reserves the right to comment upon any additional manuscripts intended for publication 
or public presentation which encompass information obtained during clinical studies supported 
by the company. Investigator(s) will be requested to submit their final manuscript to Straumann 
and will receive comments from the company according to the time frame specified in the 
Clinical Study Agreement. 
 
 

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13 Protocol Signature Page  
Center Number:  
Protocol: 
Clinical Study number CR 02/15 
Study Title: 
A Multi-Center, Prospective, Single Cohort, Post-Market Clinical Follow-Up 
(PMCF) Study to Assess Implant Survival after Insertion of Straumann® Bone 
Level Tapered (BLT) Implant Ø 2.9 mm in the Clinical Practice Setting 
Version: 
Version 2.0; Date: 09-Aug-2017 
 
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 patients. 
 
Signatures: 
 
 
 
 
 
Printed name Study 
Investigator 
 
Signature  
 
Date 
 
 

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14 References 
 
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13Zirconium versus Titanium Grade IV small-diameter bone level implants in edentulous mandibles--
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Implants. 2004; Supplement; 19:26-28.  
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Lekholm U, Zarb GA, Albrektsson T. Patient selection and preparation. Tissue integrated prosthesis. 
Chicago. Quintessence Publishing Co. Inc., 1985; 199-209. 

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Albrektsson T, Isidor F. Consensus report of session IV. Proceedings of the 1st European Workshop on 
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