Prospective, Randomized, Split-mouth Study Evaluating Clinical Performance of 3M™ Scotchbond™ Universal Plus Adhesive Compared to 3M Scotchbond Universal Adhesive for Posterior Class I & II Restorations With 3M Filtek™ Universal Restorative
Phase: NA
Conditions: Cavities of Teeth, Dental Decay
Sponsor: Solventum US LLC

3M 
HealthCare 
 
CLINICAL INVESTIGATION 
PLAN 
CLIN-PROT-CIP-11-050069 
Version: 3 
Status: Release 
 
 
3M CONFIDENTIAL 
Release Date: 01/27/2022 08:22:29 AM CST 
Page 1 of 64 
Study Title 
Prospective, randomized, split-mouth study evaluating the clinical 
performance of a new dental adhesive, 3M™ Scotchbond™ 
Universal Plus Adhesive, compared to 3M™ Scotchbond™ 
Universal Adhesive when used for posterior Class I and Class II 
restorations with 3M™ Filtek™ Universal Restorative 
Study Number 
EM-11-050069 
CIP Version 
1 
Release Date 
01/27/2022 08:22:29 AM CST 
Name of Device 
Under Investigation 
Scotchbond™ Universal Plus  
Sponsor Address 
3M Company 
3M Healthcare Business Group 
3M Center – 270-4N 
St. Paul, MN. 55144  
Manufacturer 
Address 
3M Deutschland GmbH 
Carl-Schurz-Str. 1 
41453 Neuss -Germany 
 
ELECTRONIC SIGNATURES: 
Signer 
Role 
Date Signed 
us267473:Myhre Paula E 
Clinical 
January 27, 2022 08:22:09 AM CST 
GES10885:Wittig-Barger Ulrice 
Regulatory and 
Compliance 
January 27, 2022 04:22:04 AM CST 
AASAAZZ:Lin Chee Paul 
Clinical 
January 26, 2022 11:33:54 AM CST 
ge320710:Syrek Andreas 
Medical Monitor 
January 27, 2022 01:42:53 AM CST 
 
3M Confidential 
This document contains confidential information that is the property of 3M and is 
subject to all the restrictions on its use and disclosure contained in the study contract 
to which this is appended. Do not copy, disclose, circulate, or use for benefit for any 
third party without written authorization from 3M. 
 
 

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Release Date: 01/27/2022 08:22:29 AM CST 
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Investigator Statements of Compliance  
This clinical investigation shall be conducted in accordance with the ethical principles that 
have their origin in the Declaration of Helsinki. 
This clinical investigation shall be conducted in accordance with ISO-14155:2011 and 
future versions, US FDA 21 CFR parts 812, 50, 54, 56, and any regional or national 
regulations, as appropriate.  
The clinical investigation shall not begin until the required approval/favorable opinion from 
the Institutional Review Board (IRB)/Ethics Committee (EC) and regulatory authority (if 
applicable) has been obtained and permission to proceed has been received from the study 
Sponsor. Any additional requirements imposed by the IRB/EC or regulatory authority shall 
be followed.  
I have read the Clinical Investigation Plan (CIP), including all appendices, as well as 
supporting study related documents and I agree that it contains all necessary details for me 
and my staff to conduct this study as described. I agree to record all adverse events/ 
deviations and report those adverse events/ deviations to the Sponsor per this CIP and 
IRB/EC per local requirements. I always agree to maintain product accountability and 
ensure security of study materials. I agree to comply with financial disclosure requirements. 
All subjects will sign and date the approved Informed Consent before any study procedures 
are conducted, as applicable 
I will ensure that all subjects meet inclusion criteria before enrolling them in the study. 
I agree to maintain and retain records as required by this Clinical Investigation Plan. 
Investigator’s 
Signature: 
 
Date: 
Investigator’s Name: 
Jorge Perdigao, DMD, MS, PhD 
Institution: 
University of Minnesota 
School of Dentistry 
Department of Restorative Sciences 
Investigator’s 
Signature: 
 
Date: 
Investigator’s Name: 
Hooi Pin Chew (BDS, FDSRCS, PhD) 
Institution: 
University of Minnesota 
School of Dentistry 
Department of Restorative Sciences 

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CLINICAL INVESTIGATION 
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CLIN-PROT-CIP-11-050069 
Version: 3 
Status: Release 
 
 
3M CONFIDENTIAL 
Release Date: 01/27/2022 08:22:29 AM CST 
Page 3 of 64 
ABBREVIATIONS/ACRONYMS 
ADE 
adverse device effect 
AE 
adverse event 
AFR 
annual fail rate 
ASA 
American Society for Anesthesiologists 
BPA 
bisphenol A 
CIP 
Clinical Investigation Plan 
Co-PI 
Co-Principal Investigator 
CRF 
Case Report Form 
d 
days 
DCA 
dual-cure activator 
DD 
device deficiency 
EC 
Ethics Committee 
eCRF 
electronic Case Report Form 
FDA 
Food & Drug Administration 
FDI 
Fédération Dentaire Internationale (World Dental Federation) 
GCP 
good clinical practice 
GI 
glass ionomer 
HIPAA 
Health Insurance Portability and Accountability Act 
ICF 
informed consent form 
IDE 
investigational device exemption 
IRB 
Institutional Review Board 
mos 
months 
MP 
Monitoring Plan 
PHI 
Personal Health Information 
SAP 
Statistical Analysis Plan 
SADE 
serious adverse device effect 
SAE 
serious adverse event 
SE 
self-etch 
SBU 
Scotchbond™ Universal 
SBU+ 
Scotchbond™ Universal Plus  
SOP 
standard operating procedure 
TE 
total-etch 
USADE 
unanticipated serious adverse device effect 
yr 
year 
 
 

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Status: Release 
 
 
3M CONFIDENTIAL 
Release Date: 01/27/2022 08:22:29 AM CST 
Page 4 of 64 
TABLE OF CONTENTS  
1. 
SYNOPSIS ......................................................................................................................... 7 
2. 
IDENTIFICATION AND DESCRIPTION OF THE INVESTIGATIONAL DEVICE . 14 
2.1 
Device Regulatory Classification 
15 
2.2 
Intended Use of Device 
15 
3. 
JUSTIFICATION FOR THE STUDY DESIGN OF THE CLINICAL 
INVESTIGATION .................................................................................................................... 16 
3.1 
Background 
16 
3.2 
Rationale For Studying The Specific Population/Condition 
18 
3.3 
Rationale For Study Design 
18 
4. 
BENEFITS AND RISKS OF THE INVESTIGATIONAL DEVICE, CLINICAL 
PROCEDURE, AND CLINICAL INVESTIGATION............................................................. 19 
4.1 
Benefits of the Device 
19 
4.2 
Risks of the Device 
19 
4.3 
Anticipated Adverse Device Effects 
19 
4.4 
Residual Risks 
19 
4.5 
Risk of Interactions with Concomitant Medical Treatments 
19 
4.6 
Mitigation of Risk 
20 
4.7 
Rationale for Benefit-Risk Ratio 
20 
5. 
OBJECTIVES OF THE CLINICAL INVESTIGATION PLAN .................................... 20 
5.1 
Purpose 
20 
5.2 
Primary Objective 
20 
5.3 
Endpoints 
21 
5.3.1 
Primary Endpoints .............................................................................................. 21 
5.3.2 
Secondary Endpoints .......................................................................................... 21 
5.3.3 
Safety Endpoints ................................................................................................. 21 
6. 
DESIGN OF CLINICAL INVESTIGATION ................................................................. 22 
6.1 
Design 
22 
6.2 
Investigational Device(s) and Comparator(s) 
22 
6.3 
Subject Enrollment 
23 
6.3.1 
Enrollment Criteria ............................................................................................. 23 
6.4 
Procedures and Assessments 
25 
6.4.1 
Procedures and Assessments Diagram................................................................ 25 
6.4.2 
Informed Consent Process .................................................................................. 26 
6.4.3 
Demographics and Subject Characteristics ......................................................... 26 
6.4.4 
Vital Signs ........................................................................................................... 27 
6.4.5 
Randomization .................................................................................................... 27 
6.4.6 
Intra-oral photographs ......................................................................................... 27 
6.4.7 
Restoration and Application of Study Treatments .............................................. 27 

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6.4.8 
Post-Restoration Assessments ............................................................................ 28 
6.4.9 
Adverse Events and Adverse Device Effects ...................................................... 34 
6.4.10 Prohibited Procedures and Treatments ............................................................... 34 
6.4.11 End of Study Documentation .............................................................................. 34 
6.5 
Subject Withdrawal 
34 
6.5.1 
Reasons for Subject Withdrawal ......................................................................... 34 
6.5.2 
Reasons for Tooth Withdrawal ........................................................................... 35 
6.5.3 
Handling of Withdrawal or Termination ............................................................ 35 
6.6 
VISIT SCHEDULE AND DESCRIPTION OF STUDY VISITS 
36 
6.6.1 
Point of Enrollment ............................................................................................. 36 
6.6.2 
Visits ................................................................................................................... 36 
6.6.3 
Point of Exit ........................................................................................................ 39 
6.7 
Role of Sponsor Representation 
39 
6.7.1 
Monitoring .......................................................................................................... 39 
6.7.2 
Other Sponsor Oversight..................................................................................... 40 
7. 
STATISTICAL DESIGN AND ANALYSIS .................................................................. 40 
7.1 
Statistical Hypotheses 
41 
7.2 
Sample Size Determination 
41 
7.3 
Population for Analyses 
41 
7.4 
Statistical Analyses 
41 
7.4.1 
Demographics and Baseline Characteristics ....................................................... 42 
7.4.2 
Analysis of Primary Endpoints ........................................................................... 42 
7.4.3 
Analysis of Secondary Endpoints ....................................................................... 42 
7.4.4 
Analysis of Safety Endpoint ............................................................................... 43 
7.5 
Planned Interim Analyses and Criteria for Clinical Investigation 
43 
7.6 
Procedures for Missing, Unused or Spurious Data 
43 
7.7 
Procedures for Reporting Deviations from Statistical Plan 
43 
7.8 
Validation Plan 
44 
8. 
DATA MANAGEMENT................................................................................................. 44 
8.1 
Data Collection and Management Responsibilities 
44 
8.2 
Study Records Retention 
44 
8.3 
Sponsor Oversight 
45 
9. 
AMENDMENTS TO THE CIP ....................................................................................... 45 
10. DEVIATIONS FROM THE CIP ..................................................................................... 45 
10.1 
Deviation Reporting Timelines 
46 
11. DEVICE ACCOUNTABILITY....................................................................................... 46 
11.1 
Device Labeling 
47 
11.2 
Additional Study-Specific Equipment/Device(s) 
48 
12. STATEMENTS OF COMPLIANCE .............................................................................. 48 

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12.1 
Ethical Considerations 
48 
12.2 
Periodic Reviews 
48 
12.3 
Participant Confidentiality 
48 
12.4 
Conflict of Interest 
49 
12.5 
Insurance 
49 
13. ADVERSE EVENTS, ADVERSE DEVICE EFFECTS, AND DEVICE 
DEFICIENCIES ........................................................................................................................ 50 
13.1 
Safety and Event Reporting Definitions 
50 
13.2 
Classification of Events 
51 
13.2.1 Severity Ratings .................................................................................................. 51 
13.2.2 Relatedness to Study Treatment.......................................................................... 51 
13.3 
Reporting Timelines 
52 
13.4 
Details Concerning Safety Recording and Reporting Requirements 
53 
13.4.1 Investigator ......................................................................................................... 53 
13.4.2 Sponsor ............................................................................................................... 53 
13.5 
Anticipated Adverse Events and Adverse Device Effects 
54 
14. VULNERABLE POPULATION ..................................................................................... 54 
15. SUSPENSION OR PREMATURE TERMINATION OF THE CLINICAL 
INVESTIGATION PLAN ........................................................................................................ 55 
15.1.1 By Sponsor .......................................................................................................... 56 
15.1.2 By IRB ................................................................................................................ 56 
16. REGISTRATION AND PUBLICATION POLICY ........................................................ 56 
16.1 
Public Registration 
56 
16.2 
Publications Resulting From Study 
56 
17. BIBLIOGRAPHY ............................................................................................................ 56 
18. STUDY-SPECIFIC APPENDICES................................................................................. 59 
18.1 
Appendix A. American Association of Anesthesiologists (ASA) Physical Status 
Classification System 
60 
18.2 
Appendix B. Grace and Smales Mobility Index 
61 
18.3 
Appendix C. ICDAS Radiographic Scoring System 
62 
18.4 
Appendix D.   Revision History 
63 
 

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1. 
SYNOPSIS 
Study Title 
Prospective, randomized, split-mouth study evaluating the clinical 
performance of a new dental adhesive, 3M™ Scotchbond™ 
Universal Plus Adhesive, compared to 3M™ Scotchbond™ 
Universal Adhesive when used for posterior Class I and Class II 
restorations with 3M™ Filtek™ Universal Restorative
Study Type 
Post-market, interventional 
Principal 
Investigator (PI) 
Name: Jorge Perdigao, DMD, MS, PhD 
Title:  Professor  
Site:   University of Minnesota  
           Department of Restorative Sciences 
Office Address:  
8-450 Moos Tower 
515 Delaware St. SE 
Minneapolis, MN 55455 
Email: perdi001@umn.edu 
Telephone: 612-625-8486 
Co-Principal 
Investigator 
(Co-PI) 
Name: Hooi Pin Chew (BDS, FDSRCS, PhD) 
Title:  Associate Professor  
Site:   University of Minnesota  
           Department of Restorative Sciences 
Office Address: 
16-256B Moos Tower 
515 Delaware St. SE 
Minneapolis, MN 55455 
Email: chew0014@umn.edu 
Telephone: 612-625-6975 
 
Co-Investigators  
 
Name: Erin C. Westmeyer (DDS) 
Title: Clinical Assistant Professor 
Site: University of Minnesota  
         Department of Restorative Sciences 
Office Address: 
7-519 Moos Tower 
515 Delaware St. SE 
Minneapolis, MN 55455 
Email: john6720@umn.edu 
Telephone: 612-625-0482 

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Name: Ignatius K. Lee (DDS, MS) 
Title: Clinical Associate Professor 
Site: University of Minnesota  
         Department of Restorative Sciences  
Office Address: 
16-256B Moos Tower 
515 Delaware St. SE 
Minneapolis, MN 55455 
Email: leexx009@umn.edu 
Telephone: 612-625-3240 
 
Name: Brian Hatch (DDS) 
Title: Clinical Assistant Professor  
Site: University of Minnesota 
Department of Primary Dental Care 
Office Address: 
9-268 Moos Tower  
515 Delaware St. SE 
Minneapolis, MN 55455 
Email: hatch078@umn.edu 
Telephone: 651-334-3707 
Device under 
Investigation 
Summary 
The investigational device in this study is Scotchbond™ Universal 
Plus (SBU+) Adhesive, which is manufactured by 3M. It is a light-
curing, single-component dental adhesive that is compatible with 
light-, dual-, and self-cure composite filling materials, cements, and 
core build-up materials. The adhesive can be used for "self-etch" 
procedures, selective enamel etching procedures, or "total-etch/etch-
and-rinse" procedures, and a separate dual-cure activator (DCA) is 
not necessary. The intended purpose of SBU+ Adhesive is to be 
used as a bond-promoting substance between the tooth and dental 
restorations. It may also be used as a dentin sealant and as a bonding 
agent for repair of restorations. The intended users of Scotchbond™ 
Universal Plus Adhesive are qualified dental professionals who have 
theoretical and practical knowledge on usage of dental products. 
Sponsor 
3M  
3M Healthcare Business Group 
3M Center – 270-4N 
St. Paul, MN. 55144 
Purpose 
The purpose of this study is to confirm the clinical effectiveness of 
Scotchbond™ Universal Plus Adhesive by comparing it with the 
predicate adhesive device. 

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Design 
This is a prospective, randomized, controlled, open-label, assessor-
blinded, split-mouth, single-center post-market clinical follow-up 
study. The study will enroll a minimum of 50 Subjects.  
Selection of 
Subjects 
To be considered eligible for randomization, Subjects must meet all 
the inclusion criteria and none of the exclusion criteria. Subjects are 
to be assessed for eligibility no more than 21 days prior to the 
planned oral care procedures, and eligibility will be confirmed on 
the day of the restorations. If, for any reason, a Subject’s restorative 
appointment is delayed beyond 21 days after consent, then the 
Subject will be reassessed to ensure that they still meet the eligibility 
criteria. Subjects who have provided informed consent but who do 
not meet all eligibility criteria at the time of the restorations will not 
be eligible for randomization, will not qualify for participation in the 
study, and will be considered a screening failure. 
 
Inclusion Criteria:  
Inclusion criteria include the following: 
1. The Subject is between the ages of 18 and 70 years old at 
time of consent. 
2. The Subject requires at least two direct composite 
restorations for posterior Class I or Class II carious lesions in 
vital teeth that are asymptomatic and with minimal mobility 
(< 1 mm in the buccolingual direction). 
3. Study teeth have a minimum buccolingual diameter of the 
occlusal surface that is at least 1/3 of the distance between 
the buccal and lingual cusps. 
4. Teeth selected for Class II restorations need to have an 
adjacent tooth in a position that will allow for a contact 
relationship to be established. 
5. The Subject is able and willing to sign Informed Consent 
Form in English without assistance. 
6. The Subject is able and willing to be available for all 
scheduled study visits. 
7. The Subject is in good general health (ie, meets ASA Level I 
or ASA Level II classification criteria). 
8. The selected teeth need to have occlusal contact with an 
antagonistic natural tooth. 
9. The Subject has existing radiographic images of the study 
teeth of current and acceptable diagnostic quality obtained 
within the previous 12 months.

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Exclusion Criteria: 
Preoperative exclusion criteria include the following: 
1. The Subject has a history of adverse reaction to any materials 
used in this study. 
2. The Subject is pregnant or breast feeding at the time of 
screening. 
3. The Subject has fewer than 20 teeth. 
4. The Subject is taking part in or planned to be enrolled in an 
evaluation of other restorative materials at any time during 
the study. 
5. The Subject has advanced periodontal disease (ie, Grace & 
Smales Mobility Index grade ≥ 2) that involve the study 
teeth. 
6. The Subject had orthodontic appliance treatment within the 
previous 3 months. 
7. The Subject has pronounced enamel wear facets, indicting 
severe, on-going bruxism. 
8. The Subject has severe xerostomia. 
9. The study tooth has a history of or existing, prolonged tooth 
hypersensitivity. 
10. The study tooth is an abutment for fixed or removable 
prostheses. 
11. The study tooth has a fracture or is visibly cracked such that 
it may impact the longevity of the tooth. 
12. The carious lesion is stage RC5 or RC6 of the ICDAS 
radiographic scoring system. 
13. The Subject is unable to understand study procedures or 
provide consent in English. 
14. The Subject is an employee or student of the study 
investigator(s). 
 
Intraoperative exclusion criteria include the following: 
1. The Subject has pulp exposure of either study tooth during 
restoration procedure. 
Device Regulatory 
Classification 
In accordance with regulation number 21CFR872.3200 from the 
United States Food & Drug Administration (FDA), Scotchbond™ 
Universal Plus Adhesive is a 510(k)–cleared, Class II device 
(K192961) with the following indication for use: 
 
Direct Indications: 
 Bonding for all methacrylate-based light-, dual-, and self-cure 
composite or compomer filling materials

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 Root surface desensitization 
 Bonding of methacrylate-based fissure sealants 
 Protective varnish for glass ionomer fillings 
 Repair of composite and compomer fillings 
 Sealing of cavities prior to placement of amalgam restorations 
Indirect Indications: 
 Cementation of indirect restorations in combination with 
RelyX Universal and other resin cements (follow applicable 
Instructions for Use) 
 Bonding for all methacrylate-based light-, self-, and dual-cure 
core build-up materials and cements 
 Cementation of veneers when combined with RelyX Veneer 
Cement 
 Intraoral repair of composite restorations, porcelain fused to 
metal, and all-ceramic restorations without extra primer 
 Sealing of cavities and preparation of tooth stumps prior to 
temporary cementation of indirect restorations
Primary 
Objective(s) 
The primary objective of this study is to compare the clinical efficacy 
of Scotchbond™ Universal Plus Adhesive with Scotchbond™ 
Universal Adhesive when used in self-etch mode for preparation of 
posterior Class I and Class II restorations using Filtek™ Universal 
Restorative material in adult patients. 
Endpoint(s) 
Primary Endpoint: 
The primary endpoints, which are based partly on the FDI World 
Dental Federation criteria, are the following criteria at the final 
assessment (24 months): 
 the proportion of Subjects with partial or complete loss of the 
restoration materials 
 fracture grade  
 marginal adaptation grade 
Secondary Endpoints:  
The secondary endpoints are the following modified FDI World 
Dental Federation criteria:  
 the proportion of Subjects with partial or complete loss of the 
restoration materials at 6 months and 12 months 
 time to restoration failure (ie, time to partial or complete loss 
of restoration) 
 fracture grade at 6 months and 12 months 

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 marginal adaptation grade at baseline, 6 months, and 12 
months  
 approximal anatomical form (contact point) grade at 
baseline, 6 months, 12 months, and 24 months 
 incidence of recurrent caries at 6 months, 12 months, and 24 
months 
 marginal staining grade at baseline, 6 months, 12 months, 
and 24 months 
 surface staining grade at baseline, 6 months, 12 months, and 
24 months 
 color match and translucency grade at baseline, 6 months, 
12 months, and 24 months 
 surface luster grade at baseline, 6 months, 12 months, and 
24 months 
 postoperative hypersensitivity and tooth vitality grade at 
6 months, 12 months, and 24 months 
Safety Endpoints: 
The safety endpoint is the incidence of Adverse events (AEs). 
Randomization 
Subjects who satisfy all inclusion criteria and none of the exclusion 
criteria and who have provided informed consent will be eligible for 
randomization, which will occur immediately after teeth preparation 
but before the initial application of any adhesive agent. A unique 
Subject identification number will be assigned upon enrollment, and 
study data will be reported according to this unique Subject identifier. 
The unique Subject identification number will not contain 
information that could identify the Subject. 
Randomization of the premolars or molars, which will be numbered 
using the Universal Numbering System (premolars = 4-5, 12-13, 20-
21, or 28-29; molars = 1-3, 14-16, 17-19, or 30-32), to study 
treatments will be centralized and electronic. Either two pre-molars or 
two molars from each Subject will be randomized in a 1:1 ratio such 
that one of the teeth will be randomized to undergo restoration using 
SBU+ Adhesive (Treatment), and the other tooth will undergo 
restoration using SBU Adhesive (Control). Study teeth will be 
assigned randomization numbers starting with the lowest tooth 
number. The first material for assignment according to the 
randomization schedule will be assigned to the lower tooth number in 
the pair. 

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Duration of the 
Study 
The entire duration of the study is expected to last approximately 
3 years, with individual Subject participation expected to last up to 
2 years (± 45 days). 
Subject participation will include the following: 
 Screening visit (no more than 21 days before tooth restoration) 
 Restoration procedures and baseline assessments – Day 0 
 Follow-up visits after the restorations at: 
o 6 months (± 14 days)  
o 1 year (± 30 days)  
o 2 years (± 45 days) 
Subjects may participate in additional unscheduled visits as required 
during the study if evaluation of any study tooth is required outside of 
the scheduled study visits.  
Sponsor Study 
Contact 
Name: Paula Myhre (Clinical Project Manager and Study Monitor) 
Address: 3M Center, 270-4N-04 St. Paul, MN 55144-1000 
Telephone: 651-733-1294 
Email: pemyhre1@mmm.com 
Medical Monitor 
Contact 
Name: Dr. Andreas Syrek  
Address: 3M Deutschland GmbH, ESPE Platz 82229 Seefeld, 
Germany 
Telephone: +49 8152 700 1334 
Email: asyrek@mmm.com 

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2. 
IDENTIFICATION AND DESCRIPTION OF THE INVESTIGATIONAL 
DEVICE 
The investigational device in this study is Scotchbond™ Universal Plus (SBU+) Adhesive, 
which is manufactured by 3M (Table 2-1). SBU+ Adhesive is a light-curing, single-component 
dental adhesive that is compatible with light-, dual-, and self-cure composite filling materials, 
cements, and core build-up materials. The adhesive can be used for "self-etch" procedures, 
selective enamel etching procedures, or "total-etch/etch-and-rinse" procedures, and a separate 
dual-cure activator (DCA) is not necessary. SBU+ Adhesive is radiopaque (radiopacity similar 
to dentin) and the formulation is bisphenol-A (BPA)-derivative free. The intended purpose of 
SBU+ Adhesive is to be used as a bond-promoting substance between the tooth and dental 
restorations. It may also be used as a dentin sealant and as a bonding agent for repair of 
restorations. The intended users of SBU+ Adhesive are qualified dental professionals who have 
theoretical and practical knowledge on usage of dental products. 
The comparator product (ie, Control product) for the investigational device will be 
Scotchbond™ Universal (SBU) Adhesive, which is also manufactured by 3M (Table 2-1). SBU 
Adhesive bonds methacrylate-based restoratives, cement and sealant materials to dentin, 
enamel, glass ionomer and various indirect restorative substrates (metals, glass ceramics, 
alumina, and zirconia) without an extra primer step. SBU Adhesive can be used reliably in total-
etch, self-etch or selective-etch mode for both direct and indirect restorations. The primary use 
is with light-cured materials, however, when used in conjunction with a separate activation 
solution, Scotchbond™ Universal DCA Dual Cure Activator, it has the capability to also bond 
to self- or dual-cure composite and cement materials that rely on self-cure polymerization. In 
this study, the comparator product will be applied and polymerized using a curing light before 
applying 3M™ Filtek™ Universal Restorative. 
Table 2-1: Device Information 
Investigational Device 
Comparator Device 
Device Name 
Manufacturer 
Device Name 
Manufacturer 
Scotchbond™ Universal 
Plus Adhesive 
3M 
Scotchbond™ 
Universal Adhesive 
3M 
 

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2.1 
DEVICE REGULATORY CLASSIFICATION 
In accordance with regulation number 21CFR872.3200 from the United States Food & Drug 
Administration (FDA), SBU+ Adhesive is a 510(k)–cleared, Class II device (K192961) with 
the following indication for use: 
Direct Indications: 
 Bonding for all methacrylate-based light-, dual-, and self-cure composite or 
compomer filling materials 
 Root surface desensitization 
 Bonding of methacrylate-based fissure sealants 
 Protective varnish for glass ionomer fillings 
 Repair of composite and compomer fillings 
 Sealing of cavities prior to placement of amalgam restorations 
Indirect Indications: 
 Cementation of indirect restorations in combination with RelyX Universal 
and other resin cements (follow applicable Instructions for Use) 
 Bonding for all methacrylate-based light-, self-, and dual-cure core build-up 
materials and cements 
 Cementation of veneers when combined with RelyX Veneer Cement 
 Intraoral repair of composite restorations, porcelain fused to metal, and all-
ceramic restorations without extra primer 
 Sealing of cavities and preparation of tooth stumps prior to temporary 
cementation of indirect restorations  
2.2 
INTENDED USE OF DEVICE 
For the teeth of Subjects in this study that are randomized into the Treatment arm, SBU+ 
Adhesive will be applied and polymerized using a curing light before applying 3M™ Filtek™ 
Universal Restorative. For this study, SBU+ Adhesive will be used in accordance with its 
cleared labeling and indications for use and is, therefore, exempt from the investigational device 
exemptions (IDE) regulation because it meets the conditions for an exempt investigation as 
provided in paragraph C of 21CFR812.2 from the FDA. The indications, precautionary 
measures, and instructions can be found in the IFU document for SBU+ Adhesive (3M). 

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3. 
JUSTIFICATION FOR THE STUDY DESIGN OF THE CLINICAL 
INVESTIGATION 
3.1 
BACKGROUND 
Class I and Class II Dental Caries 
Class I and Class II dental caries lesions occur on various surfaces of the mandibular and 
maxillary posterior teeth (ie, premolars and molars) and can range in severity from incipient to 
severe.1  Direct restoration of posterior tooth caries, which is the focus of this study, have 
traditionally involved the use of amalgam fillings. However, the use of resin composites, which 
are chemically and micromechanically bound to the dentin and enamel by dental resin 
adhesives2, to restore posterior tooth caries has increased over the past few decades due in part 
to the poor esthetics of amalgam and concerns about mercury content in amalgam alloys. Since 
dental resin adhesives are known to critically impact the performance of resin restorations2, this 
study focuses on retention, fracture, and marginal integrity (ie, marginal adaptation) when using 
two different dental resin adhesives to bond a resin composite to the dentin and enamel of Class 
I and Class II carious lesions. 
Resin Composite Restorations on Posterior Teeth 
Resin composite restorations, like all restorations, undergo extreme challenges in the oral 
cavity, including mechanical degradation (eg, thermocycling from hot and cold food and 
beverage consumption), chemical and biochemical degradation, short-term elution of unreacted 
composite monomers, and long-term enzymatic breakdown due, in part, to hydrolase/esterase 
activity in the oral cavity.2  For these reasons and others, composite restoration failure is a major 
concern and can lead to costly repair or replacement of the restoration, potentially more costly 
treatments (eg, root canal therapy), or eventual loss of the tooth.2   
A 2015 meta-analysis of posterior teeth restorations using either amalgam or composite resin, 
showed a mean annual fail rate (AFR) for composite resin restorations of 3.17%.3  A meta-
analysis of longitudinal studies with at least a 5-year follow-up for composite restorations of 
posterior teeth showed an AFR of 1.8% for all restorations analyzed and a 3.2%-3.5% AFR for 
medium-caries-risk to high-caries-risk patients.4  Similarly, two single-center studies of 
restorations for Class II caries reported an AFR of composite restorations ranging from 1.78% 
to 2.9%.5, 6  The leading cause for restoration failure in posterior teeth was secondary caries 
occurring at the margin between the restoration materials and the remaining tooth.5   
Classification of Dental Resin Adhesives & Retention in Class1 and Class II Restorations 
Contemporary dental resin adhesives are generally classified by their mode of application, 
including the following: (i) self-etch (SE) adhesives, which use a non-rinse acidic monomer to 

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simultaneously condition and prime the enamel/dentin; (ii) total etch (TE) adhesives, also 
known as etch-and-rinse adhesives, which involved the application of phosphoric acid followed 
by rinsing; (iii) selective etch adhesives, whereby an etch/rinse application occurs only on the 
enamel surrounding a lesion; and (iv) glass ionomer (GI) adhesives, which micromechanically 
bond to the tooth structure following a mild acid pre-treatment.2, 7   
To date, there have been several publications describing comparative prospective studies or 
randomized controlled trials focused on comparing different types of contemporary adhesives 
(eg, SE vs TE vs GI) when used for posterior tooth restorations.8-13  Four of these studies8, 10, 11, 
13 used USPHS scoring criteria (ie, Alfa, Beta, or Charlie, with Alfa being “Excellent”14) to 
compare restorations using different types of contemporary adhesives, and one study12 used 
FDI scoring criteria (ie, ranging from 1-5 with a score of 1 being “Excellent” and 5 being 
“Poor”15) to compare restorations. One study used both USPHS and FDI criteria to score 
restorations.9  Of these 6 publications, only 2 assessed functionality of the restorations placed 
using different adhesives related to retention, fracture, and marginal adaptation (ie, marginal 
integrity) after 2 years;8, 10 the others assessed functionality (ie, retention, fracture, or marginal 
adaptation) after 1 year11-13 or after 1 year to 20 months9. Using USPHS scoring criteria, 
retention scores of Alfa for restorations using two different TE adhesives (3M™ Adper™ 
Scotchbond™ 1 XT and Bisco One-Step™ Plus) were 100% after 2 years, while retention 
scores of Alfa for restorations using 4 different types of SE adhesives (3M™ Adper™ 
Scotchbond™ SE, 3M™ Adper™ Prompt™ L-Pop, Kuraray CLEARFIL™ S3™ Bond, or 
Heraeus Kulzer iBond™) ranged from 90.5% to 92%.8, 10  In these two studies, marginal 
adaptation scores of Alfa after 2 years were reported to range from 9.5% to 66.7% for 
restorations using the 4 different types of SE adhesives, whereas restorations placed with the 
two different TE adhesives ranged from 83.3% to 87%.8, 10  In one of the studies, Perdigao et 
al, the percentage of restorations with a fracture score of Alfa after 2 years was similarly lower 
(90.5% to 92%) when the restoration included the SE adhesives vs when the restoration 
included the TE adhesive (100%).10 
Scotchbond™ Universal Adhesives 
Scotchbond™ Universal Plus (SBU+) Adhesive, which is based on the chemistry of a predicate 
device, Scotchbond™ Universal (SBU) Adhesive, is a multimode dental resin adhesive that can 
be used in self-etching or total-etching (with or without selective enamel etching) procedures. 
While there have been no publications regarding clinical studies of SBU+ Adhesive, there has 
been 1 publication reporting on the laboratory evaluation of SBU Adhesive on extracted human 
teeth (ie, ex vivo study) and 16 publications reporting on clinical trials that included the use of 
SBU Adhesive.9, 13, 16-29  The ex vivo study assessed microtensile bond strength, nanoleakage, 
and in situ degree of conversion using extracted, caries-free, human third molars.22  Two 

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publications were related to the treatment of caries in primary teeth, with one of the publications 
being a trial design only19, 23, and 11 publications reported the use of SBU Adhesive in 
restoration of NCCLs.16-18, 20, 21, 24-29  The remaining two publications reported on  Class I and 
Class II cavity restorations.9, 13   
Balkaya et al compared a micro-hybrid composite resin with a bulk-fill composite resin and 
high-viscosity GI cement when used to restore Class II restorations; in this study, SBU 
Adhesive was used for both a micro-hybrid composite resin and a bulk-fill composite resin, but 
there was no mention of whether SBU Adhesive was applied using an SE or a TE procedure.13  
In contrast, Carvalho et al compared Class I and Class II restorations using SBU Adhesive 
applied via total etching (TE), via self-etching (SE), or via selective enamel etching.9  After 12 
to 20 months, 100% of the restorations were scored as acceptable, having a USPHS score of 
Alfa, for retention.9  In addition, 45 of 46 (97.8%) restorations using SBU Adhesive via SE had 
a fracture score of Alfa after 12 to 20 months, and the 92 teeth that had been restored using 
SBU Adhesive applied via TE (n = 46) or using SBU Adhesive applied via selective enamel 
etching (n = 46) had fracture scores of Alfa (100%).9  Marginal adaptation scores after 12-20 
months for teeth that had been restored using SBU Adhesive were: TE = 45 of 46 with score of 
Alfa (97.8%); SE = 44 of 46 with a score of Alfa (95.7%); and Selective enamel etching = 45 
of 46 with a score of Alfa (97.8%).9  
3.2 
RATIONALE FOR STUDYING THE SPECIFIC POPULATION/CONDITION 
Subjects with Class I or Class II carious lesions (ie, in molars or premolars) were selected as 
the specific population/condition for this study since these types of caries have been reported 
to account for 68.5% of all dental caries30, making restorations for posterior teeth caries a 
frequently performed procedure for dental practitioners. 
3.3 
RATIONALE FOR STUDY DESIGN 
To have a high level of evidence, a prospective, controlled, within-subject, randomized, single 
center trial was the design selected for this study. The within-subject design includes 
randomizing one tooth of a Subject to the Treatment arm and one other tooth to the Control 
arm, thereby allowing each Subject to be exposed to both treatment arms. SBU Adhesive was 
selected as the comparator (Control product) as it is the predicate device for SBU+ Adhesive 
and, as mentioned in Section 3.1, has been studied previously in self-etch and total-etch mode 
restorations of Class I and Class II restorations.9 SE mode restorations have been selected for 
this study based on a previous study showing that Class I/Class II restorations using SBU 
Adhesive applied via SE mode or applied via TE mode have similar retention rates9, and SE 
mode does not require the use of an additional variable (an acid etchant). To further limit study 
variables, Filtek™ Universal Restorative material will be used for both the Treatment arm and 

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the Control arm, which will allow for the collection of information related to this composite 
resin.  
The primary endpoints of this study are restoration retention, fracture, and marginal adaptation 
scoring since the purpose of this study is to compare SBU+ Adhesive with its predicate device 
(SBU Adhesive) in relation to functional aspects of the restorations. The follow-up period of 
24 months was selected based on previous 2-year studies of other composite resin adhesives 
showing differences in retention, fracture, and marginal adaptation scoring.8, 10 
4. 
BENEFITS AND RISKS OF THE INVESTIGATIONAL DEVICE, CLINICAL 
PROCEDURE, AND CLINICAL INVESTIGATION  
4.1 
BENEFITS OF THE DEVICE 
The clinical benefit of the investigational device (SBU+ Adhesive) and the control device (SBU 
Adhesive) is that they hold direct restorations in place, hold indirect restorations in place when 
used in combination with a luting agent, and help in sealing and desensitization. 
4.2 
RISKS OF THE DEVICE 
Dental adhesives are commonly used medical devices throughout dental care settings that have 
resulted in few problems. A potential risk to the Subjects in this study includes an allergic 
reaction by skin contact. If an allergic reaction occurs, the Subject should seek medical attention 
as needed, the product should be removed if necessary, and future use of the device should not 
occur. 
4.3 
ANTICIPATED ADVERSE DEVICE EFFECTS 
Due to substances in the investigative device and the comparator device used for this study, it 
is anticipated that the device may cause an allergic reaction by skin contact in certain 
individuals. Symptoms of allergic reactions (eg, erythema) are being captured as adverse events 
in this study.  
4.4 
RESIDUAL RISKS 
The Subjects will undergo long-term exposure to polymerized material, including polymerized 
acrylate, which is more inert (ie, less sensitizing) than monomeric acrylate. Therefore, residual 
risks are expected to be minimal. 
4.5 
RISK OF INTERACTIONS WITH CONCOMITANT MEDICAL TREATMENTS 
There is minimal risk of interaction between the investigative device or the comparator device 
and concomitant medical treatments. The manufacturer advises against the use of substances 

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such as desensitizers, disinfectants other than chlorhexidine-containing agents, astringents, 
dentin sealants, and rinsing solutions before applying SBU+ Adhesive as residues of these 
substances can be detrimental to the bonding strength of the device. Only chlorhexidine-
containing solutions are permitted during cavity/tooth preparation prior to restoration in this 
study (see Section 6.4.7.1). 
4.6 
MITIGATION OF RISK 
Risk related to the device may be mitigated or controlled through appropriate selection of study 
Subjects for inclusion into this study, adherence to this Clinical Investigation Plan (CIP), and 
reporting of Adverse Events (AEs), Device Deficiencies (DDs), and deviations to the Sponsor. 
For example, Subjects with known acrylate allergies are excluded from participating in this 
study (see Section 0).  
4.7 
RATIONALE FOR BENEFIT-RISK RATIO 
Insertion of direct restorations is a standard of care in dentistry. All products used in this study 
are commercially available, have regulatory clearance (e.g. 510K, CE mark), will be used per 
their respective Instructions for Use including the indications, and thus can be used for routine 
clinical treatment. 
Based upon the risks and benefits listed above and adherence to this CIP, the study Subjects are 
at no greater risk of harm than individuals being treated for similar lesions who are not 
participating in this study. The use of SBU+ Adhesive is being used in accordance with its 
intended use consistent with standard dental treatment plans for patients not participating in this 
study. 
5. 
OBJECTIVES OF THE CLINICAL INVESTIGATION PLAN 
5.1 
PURPOSE 
The purpose of this study is to confirm the clinical effectiveness of Scotchbond™ Universal 
Plus Adhesive by comparing it with the predicate adhesive device. 
5.2 
PRIMARY OBJECTIVE 
The primary objective of this study is to compare the clinical efficacy of Scotchbond™ 
Universal Plus Adhesive against Scotchbond™ Universal Adhesive when used in self-etch 
mode for preparation of posterior Class I and Class II restorations using Filtek™ Universal 
Restorative material in adult patients. 
 

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5.3 
ENDPOINTS 
5.3.1 
Primary Endpoints 
The primary endpoints, which are based partly on the FDI World Dental Federation criteria15, 
are the following criteria at the final assessment (24 months): 
 the proportion of Subjects with partial or complete loss of the restoration materials 
 fracture grade  
 marginal adaptation grade 
5.3.2 
Secondary Endpoints 
The secondary endpoints are the following modified FDI World Dental Federation criteria:  
 the proportion of Subjects with partial or complete loss of the restoration materials at 
6 months and 12 months 
 time to restoration failure (ie, time to partial or complete loss of restoration) 
 fracture grade at 6 months and 12 months 
 marginal adaptation grade at baseline, 6 months, and 12 months  
 approximal anatomical form (contact point) grade at baseline, 6 months, 12 months, and 
24 months 
 incidence of recurrent caries at 6 months, 12 months, and 24 months 
 marginal staining grade at baseline, 6 months, 12 months, and 24 months 
 surface staining grade at baseline, 6 months, 12 months, and 24 months 
 color match and translucency grade at baseline, 6 months, 12 months, and 24 months 
 surface luster grade at baseline, 6 months, 12 months, and 24 months 
 postoperative hypersensitivity and tooth vitality grade at 6 months, 12 months, and 24 
months 
5.3.3 
Safety Endpoints 
The safety endpoint is the incidence of AEs. 

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6. 
DESIGN OF CLINICAL INVESTIGATION 
6.1 
DESIGN 
This is a prospective, randomized, controlled, open-label, assessor-blinded, split-mouth, single-
center post-market clinical follow-up study. The study will enroll a minimum of 50 Subjects 
from a single site located in Minneapolis, Minnesota, USA. Each Subject will undergo 
restorations on two independent teeth (ie, two restorations) with each tooth restoration using 
only one type of adhesive. All teeth needing treatment that are not included in the study will be 
treated by the dentist using their standard of care. 
Subjects will be seen during Screening (no more than 21 days before the restoration procedure), 
on the day of the restoration procedure (Day 0, baseline), 6 months (± 14 days) after the 
restorations, 1 year (± 30 days) after restorations, and 2 years after restorations (± 45 days). 
Subjects may participate in additional unscheduled visits as required during the study if 
evaluation of any study tooth is required outside of the scheduled study visits. Unscheduled 
visits may be initiated by either the Investigator or the Subject. The entire duration of the study 
is expected to last approximately 3 years, with individual Subject participation expected to last 
up to 2 years (± 45 days). 
To help minimize or avoid bias in the study, randomization of study teeth will occur after teeth 
preparation (see Section 6.4.5) but before the initial application of any adhesive. All 
assessments will be performed by two dental examiners that are independent of the dentist that 
placed the restorations and are blinded to the treatment arms. All examiners will be trained and 
calibrated for the scoring criteria before any Subject assessment occurs (see Section 6.4.8 for 
descriptions of assessments), and examiners will be retrained and recalibrated if any new 
evaluator is added to the list of assessors. After the second examiner has completed their 
assessments, then the examiners will compare their evaluations and a consensus will be reached 
for each of the scoring criteria at each visit. A consensus will be reached before the Subject 
leaves the visit, and the consensus assessments will be entered into the Case Report Form 
(CRF).  
6.2 
INVESTIGATIONAL DEVICE(S) AND COMPARATOR(S) 
Restorations will include the use of 3M™ Filtek™ Universal Restorative to match and blend 
to the color of the surrounding dentition. On one tooth, the restorative material will be bonded 
with SBU+ Adhesive (Treatment arm), and restorative material on the other tooth will be 
bonded using SBU Adhesive (Control arm). Both adhesives will be applied using the self-etch 
mode.  

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6.3 
SUBJECT ENROLLMENT 
Subject enrollment will remain open until a minimum of 50 subjects are enrolled and confirmed 
eligible (see Section 6.3.1). 
6.3.1 
Enrollment Criteria 
In order to be considered eligible for randomization, Subjects must meet all the inclusion 
criteria listed in Section 6.3.1.1 and none of the exclusion criteria listed in Section 0. Subjects 
should be assessed for eligibility no more than 21 days prior to the planned oral care procedures, 
and eligibility will be confirmed on the day of the restorations. If, for any reason, a Subject’s 
restorative appointment is delayed beyond 21 days after consent, then the Subject will be 
reassessed to ensure that they still meet the eligibility criteria. Subjects who have provided 
informed consent but who do not meet all eligibility criteria at the time of the restorations will 
not be eligible for randomization, will not qualify for participation in the study, and will be 
considered a screening failure. 
 
INCLUSION CRITERIA 
Subjects may be included that meet the inclusion criteria in Table 6.3.1.1-1. 
Table 6.3.1.1-1: Inclusion Criteria 
Number Inclusion Criteria 
1 
The Subject is between the ages of 18 and 70 years old at time of consent. 
2 
The Subject requires at least two direct composite restorations for posterior 
Class I or Class II carious lesions in vital teeth that are asymptomatic and with 
minimal mobility (< 1 mm in the buccolingual direction). 
3 
Study teeth have a minimum buccolingual diameter of the occlusal surface that 
is at least 1/3 of the distance between the buccal and lingual cusps 
4 
Teeth selected for Class II restorations need to have an adjacent tooth in a 
position that will allow for a contact relationship to be established. 
5 
The Subject is able and willing to sign Informed Consent Form in English 
without assistance. 
6 
The Subject is able and willing to be available for all scheduled study visits. 
7 
The Subject is in good general health (ie, meets ASA Level I or ASA Level II 
classification criteria)Section 18, Appendix A. 
8 
The selected teeth need to have occlusal contact with an antagonistic natural 
tooth.  

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Number Inclusion Criteria 
9 
The Subject has existing radiographic images of the study teeth of current and 
acceptable diagnostic quality obtained within the previous 12 months. 
 
 
EXCLUSION CRITERIA 
Subjects must be excluded from participating in this study if they meet any of the preoperative 
or intraoperative criteria listed in Tables 6.3.1.2-1 and 6.3.1.2-2. 
Table 6.3.1.2-1: Preoperative Exclusion Criteria 
Number Exclusion Criteria 
1 
The Subject has a history of adverse reaction to any materials used in this study. 
2 
The Subject is pregnant or breast feeding at the time of screening. 
3 
The Subject has fewer than 20 teeth. 
4 
The Subject is taking part in or planned to be enrolled in an evaluation of other 
restorative materials at any time during the study. 
5 
The Subject has advanced periodontal disease (ie, Grace & Smales Mobility 
Index grade ≥ 2) that involve the study teeth.Appendix B 
6 
The Subject had orthodontic appliance treatment within the previous 3 months. 
7 
The Subject has pronounced enamel wear facets, indicating severe, on-going 
bruxism. 
8 
The Subject has severe xerostomia. 
9 
The study tooth has a history of or existing, prolonged tooth hypersensitivity. 
10 
The study tooth is an abutment for fixed or removable prostheses. 
11 
The study tooth has a fracture or is visibly cracked such that it may impact the 
longevity of the tooth. 
12 
The carious lesion is stage RC5 or RC6 of the ICDAS radiographic scoring 
system.Section 18, Appendix C 
13 
The Subject is unable to understand study procedures or provide consent in 
English. 
14 
The Subject is an employee or student of the study investigator(s). 
 

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Table 6.3.1.2-2: Intraoperative Exclusion Criteria 
Number Exclusion Criteria 
1 
The Subject has pulp exposure of either study tooth during the restoration 
procedure. 
 
6.4 
PROCEDURES AND ASSESSMENTS 
The following sections describe the study procedures and data that will be collected at each 
visit for the duration of the study. The data listed below, and any relevant safety data will be 
collected during this study. 
6.4.1 
Procedures and Assessments Diagram 
 

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6.4.2 
Informed Consent Process 
Informed Consent must be obtained for each Subject that meets eligibility criteria prior to any 
study activities being performed or data being collected. The Investigator or designee will 
review all relevant aspects of the study with the potential Study subject that are relevant to the 
Subject’s decision to participate throughout the study. The Investigator or designee will provide 
ample time for the Subject to read and understand the IRB-approved ICF and to consider 
participation in the study.  
The study Subject and the Investigator (or qualified designee) must sign and date the ICF. The 
Investigator or designee must file the original ICF and provide the Subject with a copy of the 
signed and dated ICF and any other written documentation per IRB/EC requirements. Subject 
privacy language (ie, HIPAA) per local regulations may be added to the local ICF by the 
Investigator. 
The Informed Consent Process must be documented by the Investigator or designee. The 
Informed Consent Process includes documentation of the discussion regarding study 
procedures, Subject concerns, that the Subject was provided ample time to consider 
participation, and that all questions were answered prior to participation in any research activity. 
In order to minimize pressure and undue influence on vulnerable Subjects (see Section 14), the 
Investigator or designee who is obtaining Informed Consent should ensure appropriate 
communication technique, such as avoidance of jargon and using plain language. 
6.4.3 
Demographics and Subject Characteristics 
After a Subject signs the informed consent form (ICF; see Section 6.4.2) and before the initial 
tooth restoration, the following demographic data and Subject characteristics will be collected 
and documented: 
 Age 
 Sex 
 Race 
 Ethnicity 
 Tooth numbers for treated teeth 
 Date of restoration 

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6.4.4 
Vital Signs 
No vital signs (eg, height/weight) or laboratory assessments will be captured as part of this 
study. 
6.4.5 
Randomization 
Subjects who satisfy all inclusion criteria and none of the exclusion criteria and who have 
provided informed consent will be eligible for randomization, which will occur immediately 
after teeth preparation (see Section 6.4.7) but before the initial application of any adhesive 
agent. A unique Subject identification number will be assigned upon enrollment, and study data 
will be reported according to this unique Subject identifier. The unique Subject identification 
number will not contain information that could identify the Subject. 
Randomization of the premolars or molars, which will be numbered using the Universal 
Numbering System (premolars = 4-5, 12-13, 20-21, or 28-29; molars = 1-3, 14-16, 17-19, or 
30-32), to study treatments will be centralized and electronic. Either two pre-molars or two 
molars from each Subject will be randomized in a 1:1 ratio such that one of the teeth will be 
randomized to undergo restoration using SBU+ Adhesive (Treatment), and the other tooth will 
undergo restoration using SBU Adhesive (Control). Study material will be assigned according 
to the randomization schedule beginning with the lower tooth number in the pair. 
6.4.6 
Intra-oral photographs 
Intra-oral photographs will be taken in accordance with the Investigator’s standard practice. On 
the day of restorations, the mouth region(s) containing the study teeth will be photographed 
before teeth preparation and at baseline immediately after the restoration is finished and 
polished. For the 6-month, 1-year, and 2-year follow-up visits, photographs will be taken before 
clinical performance assessments are initiated. 
6.4.7 
Restoration and Application of Study Treatments 
The restoration procedure for each lesion will be performed in accordance with the 
Investigator’s standard practice, and both restorations should occur during a single visit. 
 
TOOTH PREPARATION & CAVITY CLEANING 
After application of local anesthesia, the carious lesion will be accessed using a diamond bur. 
Carious dentin up to the affected dentin will then be removed using a bur, and further cavity 
cleansing can then be performed. Beveling of the cavity margin may be performed if it is 
deemed necessary in the opinion of the Investigator. After tooth preparation and cleansing, each 
tooth will be isolated (eg, using cotton rolls and suction, a dental isolation adapter such as 
Isovac™, or a rubber dam). For preparations considered to be in deep dentin, a minimum 

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amount of calcium hydroxide followed by application of type III resin-modified glass ionomer 
cement (ie, 3M™ Vitrebond™ Plus) may be applied for pulp capping. Restorations for each 
tooth will be performed as described in Sections 6.4.7.2 and 6.4.7.3. 
 
TREATMENT GROUP – SCOTCHBOND™ UNIVERSAL PLUS ADHESIVE 
For cavities/teeth in the Treatment arm, the SBU+ Adhesive will be applied following 
manufacturer’s (3M™) directions using a "self-etching” procedure. After application and 
polymerization of the adhesive using a calibrated Elipar™ DeepCure-S Curing Light (see 
Section 11), and after selection of an appropriate composite shade, 3M™ Filtek™ Universal 
Restorative will be placed in 2 mm increments and light-cured. After immediate occlusal 
adjustments, the restoration will be finished and polished in accordance with the Investigator’s 
standard practice using the Sof-Lex™ Disks and the Sof-Lex™ Diamond Polishing System (see 
Section 11). Finishing and polishing should be similar for teeth in both treatment arms and 
across Subjects.  
 
CONTROL GROUP – SCOTCHBOND™ UNIVERSAL ADHESIVE 
For cavities/teeth in the Control arm, the SBU Adhesive will be applied following 
manufacturer’s (3M™) directions using a "self-etching” procedure. After application and 
polymerization of the adhesive using a calibrated Elipar™ DeepCure-S Curing Light (see 
Section 11), and after selection of an appropriate composite shade, 3M™ Filtek™ Universal 
Restorative will be placed in 2 mm increments and light-cured. After immediate occlusal 
adjustments, the restoration will be finished and polished in accordance with the Investigator’s 
standard practice using the Sof-Lex™ Disks and the Sof-Lex™ Diamond Polishing System (see 
Section 11). Finishing and polishing should be similar for teeth in both treatment arms and 
across Subjects. 
 
POST-RESTORATION INSTRUCTIONS 
After completion of the restorations, the Investigator is to instruct the Subject to report any 
unusual or prolonged postoperative hypersensitivity for either study tooth that occurs during 
the first 7 days after the restorations.  
6.4.8 
Post-Restoration Assessments  
The clinical performance of the investigative device and comparator device, when used with 
3M™ Filtek™ Universal Restorative, will be assessed by post-operative physical inspection 
(eg, using a mouth mirror, standardized explorers capable of allowing for marginal gap 
assessments, and standardized blades capable of allowing for approximal contact point 
assessment) of the restoration and surrounding tooth surface of teeth in each treatment arm of 

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the study in accordance with investigator’s standard practice. Performance will be evaluated 
using criteria that include restorative material retention, fracture of restorative material, 
marginal adaptation, approximal anatomical form related to contact point, secondary caries, 
surface staining, marginal staining, color match and translucency, surface luster (ie, polish 
retention), and postoperative hypersensitivity. Scoring categories for each of these criteria is 
listed in Sections 6.4.8.1 to 6.4.8.10.  
Baseline performance assessments for marginal adaptation (Section 6.4.8.3), approximal 
anatomical form (Section 6.4.8.4), surface and marginal staining (Sections 6.4.8.6 and 6.4.8.7, 
respectively), and surface luster (Section 6.4.8.9) can be performed upon removal of 
restoration-related isolation devices (eg, rubber dams or dental isolation adapters); however, 
baseline color match and translucency scoring (Section 6.4.8.8) should be performed a 
minimum of 30 minutes after removal of restoration-related isolation devices to allow for 
rehydration. For the subsequent follow-up visits, performance assessments (listed in Sections 
6.4.8.1 to 6.4.8.10) should be performed after routine cleaning procedures, if applicable.  In 
addition, performance assessments for follow-up visits should be performed after completing 
intra-oral photography (see Section 6.4.6).  
If a tooth is withdrawn from the study (Section 6.5.2) because the tooth was missing/extracted, 
coronally fractured, or root canal filled, or the filling was replaced by a non-study dentist, then 
no further assessments will be scored for the withdrawn tooth.  If a tooth is withdrawn from the 
study (Section 6.5.2)  because of root fracture, cracks not affecting the restoration, or rampant 
caries, then final performance assessments listed in Sections 6.4.8.1 to 6.4.8.10 should be 
performed for that tooth on the day of withdrawal, excluding the postoperative hypersensitivity 
and tooth vitality assessment in the case of root fracture; no further assessments will be required 
for the withdrawn tooth after it is withdrawn. 
 
RETENTION OF RESTORATIVE MATERIAL  
Categories for retention of restorative material will include: 
1. No loss of restorative materials 
2. Partial or complete loss of restorative materials 
 
FRACTURE OF RESTORATIVE MATERIAL 
Scoring categories for the fracture of restorative material are defined as follows: 
1. Excellent/very good: No fractures/cracks 
2. Good: Small hairline cracks 

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3. Sufficient/Satisfactory: Two or more or larger hairline cracks and/or material chip 
fracture not affecting the marginal integrity or approximal contact 
4. Unsatisfactory: Material chip fractures which damage marginal quality or approximal 
contacts 
 
MARGINAL ADAPTATION  
Scoring categories for marginal adaptation are defined as follows: 
1. Excellent/very good: No clinically detectable gap. Margins represent a harmonious 
continuation of the outline at the tooth/restoration transition 
2. Good: Marginal integrity deviates from the ideal but could be upgraded to ideal by 
polishing. Small marginal chip fracture of the restoration can be eliminated by polishing 
and/or a localized gap is just perceptible. Sub-grading of good marginal adaptation 
should be applied as follows: 
a. Marginal gap, white lines. 
b. Small marginal fracture removable by polishing. 
c. Slight ditching, slight step or small flashes, minor irregularities. 
3. Sufficient/satisfactory: Leakage/discoloration is present but limited to the marginal area. 
Generalized marginal gap is easily perceptible based on clinical judgement and analysis 
of clinical photographs but cannot be modified without minor damage to the tooth or 
surrounding tissue and is not considered to result in long-term negative consequences 
for the tooth or surrounding tissue if left untreated. Presence of several small marginal 
fractures that are unlikely to cause long-term effects. Sub-grading should be applied as 
follows: 
a. Gap not removable, no dentin exposure. 
b. Several small marginal fractures. 
c. Major irregularities, ditching or flashes, steps. 
4. Unsatisfactory: Localized major gap that may result in exposure of dentine or base. 
Repair is necessary for prophylactic reasons. Sub-grading of unsatisfactory marginal 
adaptation should be applied as follows: 
a. Major gap, dentine/base exposed. 
b. Severe ditching or marginal fractures. 
c. Larger irregularities or steps (repair necessary). 

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5. Poor: Generalized major gap or irregularities; or the restoration is loose but in situ. 
Replacement is necessary to prevent further damage or there are large fractures at the 
margins and loss of material is too extensive to be repaired. 
 
APPROXIMAL ANATOMICAL FORM (CONTACT POINT) 
Scoring categories for contact points are defined as follows: 
1. Excellent/very good: Normal contact point (floss or 25-m metal blade can pass). 
2. Good: Contact slightly too strong but no disadvantage (floss or 25-m metal blade can 
only pass with pressure). 
3. Sufficient/satisfactory: Somewhat weak contact, no indication of damage to tooth, 
gingiva, or periodontal structures (50-m metal blade can pass). 
4. Unsatisfactory: Too weak and possible damage due to food impaction (100-m metal 
blade can pass). 
5. Poor: Too weak and/or clear damage due to food impaction and/or pain/gingivitis. 
 
RECURRENT CARIES 
Scoring categories for recurrent caries are defined as follows: 
1. Excellent/very good: No secondary or primary caries 
2. Good: Small and localized areas of demineralization 
3. Sufficient/satisfactory: Larger areas of demineralization 
4. Unsatisfactory: Caries with cavitation and suspected undermining caries 
5. Poor: Deep caries or exposed dentin that is not accessible for repair of restoration 
 
SURFACE STAINING 
Scoring categories for surface staining are as follows: 
1. Excellent/very good: No surface staining 
2. Good: Minor surface staining (under dry conditions), easily removable by polishing 
3. Sufficient/satisfactory: Moderate surface staining that may also present on other teeth, 
not esthetically unacceptable 
4. Unsatisfactory: Unacceptable surface staining on the restoration but not the tooth. Major 
intervention is necessary for improvement 

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5. Poor: Severe surface staining and/or subsurface staining, generalized or localized, not 
accessible for intervention (restoration may need replacement) 
 
MARGINAL STAINING 
Scoring categories for marginal staining are as follows: 
1. Excellent/very good: No marginal staining 
2. Good: Minor marginal staining, easily removable by polishing 
3. Sufficient/satisfactory: Moderate marginal staining, not esthetically unacceptable. 
4. Unsatisfactory: Pronounced (mainly localized) marginal staining and not removable by 
polishing; major intervention necessary for improvement of esthetics 
5. Poor: Deep marginal staining (generalized and/or profound), not accessible for 
intervention (restoration may need replacement) 
 
COLOR MATCH AND TRANSLUCENCY 
Scoring categories for color matching are as follows: 
1. Excellent/very good: Color and translucency of the restoration have a clinically 
excellent match with the surrounding enamel and adjacent teeth. There is no difference 
in shade, brightness or translucency between restoration and tooth. 
2. Good: Minor deviations in shade and translucency  
3. Sufficient/satisfactory: a clear deviation in color match that does not affect esthetics. 
Sub-grading of sufficient/satisfactory color match and translucency should be applied 
as follows:  
a. more opaque 
b. more translucent 
c. darker 
d. brighter 
4. Unsatisfactory: There is a (localized) discoloration or opaqueness in the restoration 
affecting the appearance of the dentition, which can be corrected by repair (veneering) 
is possible. Sub-grading of unsatisfactory color match and translucency should be 
applied as follows:  
a. too opaque 
b. too translucent 

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c. too dark 
d. too bright 
5. Poor: The restoration displays an unacceptable alteration in color and/or translucency, 
and replacement is necessary 
 
SURFACE LUSTER (POLISH RETENTION/(SURFACE 
GLOSS/ROUGHNESS) 
Scoring categories for surface luster are as follows: 
1. Excellent/very good: Surface luster is comparable to that of the surrounding enamel 
2. Good: Surface is slightly dull but not noticeable from a speaking distance of 60 – 100 cm 
3. Sufficient/satisfactory: Dull surface but still acceptable if the surface of the restoration 
is covered with a film of saliva 
4. Unsatisfactory: Surface is rough and cannot be masked by salivary film. Some polishing 
is insufficient, and further intervention (eg, re-finishing or veneering) is necessary and 
possible 
5. Poor: Surface is unacceptably rough and/or retains noticeable biofilm (plaque). 
Improvement by finishing or veneering is not feasible 
 
POSTOPERATIVE HYPERSENSITIVITY AND TOOTH VITALITY 
Postoperative hypersensitivity upon exposure of the study tooth to a cold cotton pellet or a blast 
of cold air (as determined per site procedure) will be scored according to the following 
categories: 
1. Excellent/very good: No hypersensitivity, normal vitality 
2. Good: Minor hypersensitivity for a limited period of time, normal vitality 
3. Sufficient/satisfactory: Clinically satisfactory with either of the following: 
a. moderate hypersensitivity, or 
b. delayed/mild sensitivity; no subjective complaints, no treatment needed 
4. Unsatisfactory: Clinically unsatisfactory due to: 
a. intense hypersensitivity, or 
b. delayed sensitivity with minor subjective symptoms, or 
c. no clinical detectable sensitivity 

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5. Poor: Intense, acute pulpitis or non-vital tooth 
6.4.9 
Adverse Events and Adverse Device Effects 
AEs and Adverse Device Effects (ADEs) will be collected from the time of restoration through 
the 24-month follow-up visit (optionally 3-years). AEs and ADEs will be reported according to 
Section 13. 
6.4.10 
Prohibited Procedures and Treatments 
Any dental procedure or treatment of the study teeth other than routine cleaning and the 
procedures described in Section 6.4.7 will be considered a protocol deviation. In addition, the 
use of peroxide-based tooth-bleaching agents applied to the study teeth is prohibited during the 
study and would be considered a protocol deviation. 
6.4.11 
End of Study Documentation 
Subjects may withdraw or be discontinued from this study at any time (Section 6.5 and 6.6.3). 
The Investigator may discontinue a Subject’s study participation if the Investigator feels it is in 
the best interest of the Subject. 
The following information will be documented at the End of Study: 
 Last day of study participation 
 Completion status – Did the Subject complete the study (Yes/No)? 
 Reason for study discontinuation 
6.5 
SUBJECT WITHDRAWAL  
6.5.1 
Reasons for Subject Withdrawal 
Subjects may withdraw from participation in the study at any time upon request. In addition, 
the Investigator may choose to terminate the participation of a Subject from the study with or 
without their consent. The Investigator shall record the reason for withdrawal and 
discontinuation of the study in an applicable Case Report Form (CRF). These reasons include, 
but are not limited to: 
 Study completion (all study related visit(s) are completed) 
 Withdrawal by the Subject 
 Withdrawal by Investigator 
 Lost to follow-up 

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 Death 
 Adverse events 
 Noncompliance 
 For any reason that may, in the opinion of the Investigator, negatively affect the safety 
or well-being of the Subject 
6.5.2 
Reasons for Tooth Withdrawal 
An individual study tooth may be withdrawn from the study at any time at the discretion of the 
Investigator to maintain subject safety. The Investigator shall record the reason for tooth 
withdrawal in an applicable CRF. These reasons include, but are not limited to: 
 Cracked tooth 
 Fractured tooth 
 Missing / extracted tooth 
 Replaced filling 
 Root canal 
 Rampant caries 
 Other 
6.5.3 
Handling of Withdrawal or Termination 
Every effort should be made to complete assessments required for the primary endpoint and 
safety endpoints prior to a Subject withdrawal. In the event of Subject withdrawal or 
discontinuation prior to study completion (see Section 6.5.1), study Subjects will not be 
replaced. Screen failures or Subjects who withdraw prior to randomization to treatment will be 
replaced. 
For study Subjects lost to follow-up, the Investigator shall make 3 documented attempts before 
confirming the Subject is lost to follow-up. If the study Subject withdraws from the study for 
any reason and there is an ongoing safety event, additional safety event information may need 
to be collected by the Investigator and shared with Sponsor. 
Once the Subject withdraws from the study, all study teeth will be considered withdrawn. Upon 
Subject withdrawal, no further study evaluations will be performed, and no additional data will 
be collected. The Investigator may retain and continue to use any data collected before 
withdrawal. 

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If for any reason the Subject is withdrawn by the Investigator from this study, the Investigator 
will inform the Subject and the Sponsor. 
If an individual study tooth is withdrawn from the study (see Section 6.5.2), then the remaining 
tooth may remain until study completion. 
6.6 
VISIT SCHEDULE AND DESCRIPTION OF STUDY VISITS 
6.6.1 
Point of Enrollment 
Following recruitment and eligibility screening during Visit 1, a Subject will sign the Informed 
Consent Form (ICF). A Subject is considered enrolled in this study at time the informed consent 
form is signed by the Subject. 
6.6.2 
Visits 
After informed consent has been obtained, the following study procedures and assessments will 
be performed. All applicable data are to be recorded in the applicable CRFs. 
 
SCHEDULE OF EVENTS 
A schedule of events is provided in Table 6.6.2.1-1 below: 

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Table 6.6.2.1-1. Schedule of procedures and assessments by study visit. 
Procedure Description &  
Visit Windows 
Visit 1 
Visit 2 
Visit 3 
Visit 4 
Visit 5 
Unscheduled 
Screening & 
Enrollment 
Teeth Restorations & 
Baseline Follow-up 
6-mo  
Follow-up 
1-yr  
Follow-up 
2-yr  
Follow-up 
 
 
Day -21 to 0 
Day 0 
(6 mos ± 14 d) 
(1 yr ± 30d) 
(2 yr ± 45d) 
 
Informed Consent 
X 
 
Inclusion/Exclusion Criteria 
X 
X1 
 
Demographics and Subject 
Characteristics 
X 
 
 
 
 
 
Teeth preparation 
 
X 
 
 
 
 
Randomization 
 
X 
 
 
 
 
Intra-oral photographs 
 
X2 
X3 
X3 
X3 
X3 
Restoration Procedure 
Treatment Application 
 
X 
 
 
 
 
Post-Restoration 
Assessments 
 
X4 
X 
X 
X 
X 
Adverse Events & Adverse 
Device Effects 
 
X 
X 
X 
X 
X 
End of Study 
 
 
 
 
X 
X5 
1 Confirm eligibility if screening visit and restoration occur on different days. 
2 Before teeth preparation and immediately after the restoration is finished and polished. 
3 Before clinical assessments are initiated. 
4 All assessments except Color Match and Translucency performed after removal of tooth isolation devices. Color 
Match and Translucency assessment performed at least 30 minutes after tooth isolation device removal. 
5 If the Subject is withdrawn early.

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VISIT 1 (SCREENING & ENROLLMENT VISIT – STUDY DAY -21 TO 0) 
The following procedures and assessments will be completed at Visit 1:  
1. Assessment of eligibility, as described in Section 6.3.1 
2. Informed consent, as described in Section 6.4.2 
3. Undergo screening and dental assessment to corroborate that the patient meets all 
eligibility criteria described in Sections 6.3.1 
4. Document Subject demographic and characteristics, as described in Section 6.4.3 
 
VISIT 2 (RESTORATION PROCEDURES & BASELINE ASSESSMENTS – 
STUDY DAY 0) 
The following procedures and assessments will be completed at Visit 2:   
1. Confirmation that Subject meets eligibility criteria, if Visit 2 occurs on different day 
than Visit 1 (rescreen if > 21 days) 
2. Teeth preparation, as described in Section 6.4.7.1 
3. Randomization of teeth into treatment arms, as described in Section 6.4.5 
4. Intra-oral photographs, as described in Section 6.4.6 
5. Restoration procedure for each tooth, including application of the study treatments, 
as described in Section 6.4.7 
6. All post-restoration assessments will be captured according to Section 6.4.8 
7. Assessment and documentation of adverse events and adverse device effects, as 
described in Section 6.4.9 
 
VISIT 3 (STUDY DAY – 6 MONTHS ± 14 DAYS) 
The following procedures and assessments will be completed at Visit 4:   
1. Intra-oral photographs, as described in Section 6.4.6 
2. All post-restoration assessments will be captured according to Section 6.4.8 
3. Assessment and documentation of adverse events and adverse device effects, as 
described in Section 6.4.9 
 
VISIT 4 (STUDY DAY – 1 YEAR ± 30 DAYS) 
The following procedures and assessments will be completed at Visit 5:   

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1. Intra-oral photographs, as described in Section 6.4.6 
2. All post-restoration assessments will be captured according to Section 6.4.8 
3. Assessment and documentation of adverse events and adverse device effects, as 
described in Section 6.4.9 
 
VISIT 5/FINAL VISIT (STUDY DAY – 2 YEAR ± 45 DAYS) 
The following procedures and assessments will be completed at Visit 6:   
1. Intra-oral photographs, as described in Section 6.4.6 
2. All post-restoration assessments will be captured according to Section 6.4.8 
3. Assessment and documentation of adverse events and adverse device effects, as 
described in Section 6.4.9 
4. Documentation of end of study, as described in Section 6.4.11 
 
UNSCHEDULED VISITS 
The following procedures and assessments will be completed at any unplanned visits 
involving symptoms related to the study teeth:   
1. Intra-oral photographs, as described in Section 6.4.6 
2. All post-restoration assessments will be captured according to Section 6.4.8 
3. Assessment and documentation of adverse events and adverse device effects, as 
described in Section 6.4.9 
4. Documentation of end of study, as described in Section 6.4.11, if necessary 
6.6.3 
Point of Exit 
For each Subject, the Investigator shall record the reason for withdrawal and discontinuation of 
the study in the applicable CRF, as described in Section 6.5.1. The Study Subject is considered 
to be exited from the study upon completion of the applicable CRF. 
6.7 
ROLE OF SPONSOR REPRESENTATION 
6.7.1 
Monitoring 
Study monitoring is conducted to ensure that (i) the rights, safety, and well-being of study 
participants are protected, (ii) the reported study data are accurate, complete, and verifiable, 
and (iii) the conduct of the study is in compliance with the currently approved CIP, with good 
clinical practice (GCP) principles, and with applicable regulatory requirement(s). 3M, as 

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Sponsor of this clinical investigation, is responsible for study oversight and for providing the 
PI and study staff with training regarding the proper conduct of the clinical investigation with 
regard to CIP adherence and validity of the data recorded on the CRFs. 3M, has therefore 
assigned study monitor(s) to this clinical investigation. The progress of the clinical investigation 
will be monitored by: 
 Periodic in-person and/or remote review of study documents 
 Telephone and electronic communications with the study staff and PI 
 Review of CRFs and source documents (eg, Subject records) 
The study monitor(s), other authorized representatives of the Sponsor, representatives of the 
IRB/EC, or regulatory authorities may inspect all documents and records required to be 
maintained by the Investigator, including but not limited to, Subject records (office, clinic, or 
hospital) for the participants in this study. The clinical study site personnel will permit access 
to such records. The Investigator will give 3M study monitor(s) direct access to source 
documents that support data on the CRFs, including any electronic records. If site policies 
restrict access to Subjects’ dental files to site personnel, the PI will designate a staff member to 
work with the Sponsor’s monitor to verify source documents on an as needed basis. This 
verification will be conducted in a way that will ensure that only study-related information is 
examined. 
6.7.2 
Other Sponsor Oversight 
In addition to study monitoring, the Sponsor, or their representatives may conduct the following 
tasks during this study: 
 Audits of the Investigator 
 Provision of technical support/product specific training for the study device 
Investigator non-compliance of required study responsibilities will require Sponsor sanctions 
to alleviate the non-compliance, including corrective and preventative actions up to and 
including disqualification. 
Details of clinical site monitoring are documented in a Monitoring Plan (MP). The MP 
describes in detail who will conduct the monitoring, at what frequency monitoring will be done, 
at what level of detail monitoring will be performed, and the distribution of monitoring reports. 
7. 
STATISTICAL DESIGN AND ANALYSIS 
A separate Statistical Analysis Plan (SAP) will not be generated for this study.  
 

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7.1 
STATISTICAL HYPOTHESES 
The objective is to compare the clinical effectiveness and safety between SBU+ Adhesive and 
the control, SBU Adhesive. Although the study is not powered to assess the differences in any 
of the endpoints between the two adhesives, comparisons will be made for exploratory 
purposes. 
7.2 
SAMPLE SIZE DETERMINATION 
We estimate that 50 Subjects allocated to treatment are feasible in consideration of American 
Dental Association Guidelines31 and previously published literature.9, 13 The estimated sample 
size will account for 20% drop-outs or attrition to allow a minimum of 40 subjects completing 
the study. In addition, the sample size of 100 restorations (2 restorations per subject) will 
provide acceptable precision in estimating the overall restoration survival rate.  Given an 
expected annual restoration failure rate of 3.3%32, a one-sided 95% confidence interval will 
produce an upper confidence limit of 7.7%, using the Wilson score method. 
7.3 
POPULATION FOR ANALYSES 
The following analysis sets will be used: 
 Full Analysis Set (FAS) – Full Analysis Set will consist of all randomized Subjects who 
have post-baseline data available.  
 Safety Set (SS) – Safety Set includes all Subjects who receive either SBU+ Adhesive or 
SBU Adhesive for any length of time. 
Prior to any interim or final analysis, the Subject(s) excluded from any statistical sensitivity 
analyses will be determined based on deviations deemed to impact the primary and/or secondary 
analyses. Critical deviations will include deviations related to restorations procedures (eg, not 
using SE mode), a missing assessment, and study visits outside the pre-defined windows. 
Subjects excluded from sensitivity analyses may differ for each time point and for each 
endpoint. Documentation of these decisions will occur prior to any interim analyses.  
7.4 
STATISTICAL ANALYSES 
The analysis of all endpoints will be based on the FAS with and without imputation. Statistical 
sensitivity analyses will be performed on the primary and secondary endpoints excluding those 
subjects with critical deviations related to restoration procedures, missing endpoint of interest, 
or assessment occurring outside of scheduled follow-ups. The result of sensitivity analyses will 
be presented alongside the primary FAS findings. The analysis of the safety endpoint will be 
based on SS. There will not be any adjustment for multiplicity as the study is non-confirmatory. 
All analyses will be conducted using SAS software (release 9.4 or higher). Unless otherwise 

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specified, statistical tests will be two-sided and performed at a significance level of 5%. The 
corresponding p-values and 95% confidence intervals will be reported for all analyses. 
7.4.1 
Demographics and Baseline Characteristics 
Subject demographics, baseline characteristics, and other relevant clinical information and 
treatment history will be summarized for all Subjects, and if relevant, by each treatment arm 
using descriptive statistics (frequency and percentage for categorical variables; n, mean, 
standard deviation, median, minimum and maximum for continuous variables).   
7.4.2 
Analysis of Primary Endpoints 
The primary endpoints are the proportion of Subjects with partial or complete loss of the 
restoration materials, fracture grade, and marginal adaptation grade, based on the FDI World 
Dental Federation criteria, evaluated at 24 months. Descriptive statistics will be used to 
summarize the primary endpoints for overall and by the two adhesive products using FAS with 
imputed endpoints. The Wilcoxon signed-rank test and McNemar (or Cochran-Mantel-
Haenszel) test will be used to compare the retention rate, fracture grade and marginal adaptation 
grade, as appropriate.  
7.4.3 
Analysis of Secondary Endpoints 
The secondary endpoints (listed in Section 5.3.2) include the following: 
 the proportion of Subjects with partial or complete loss of the restoration materials at 
6 months and 12 months 
 time to restoration failure (ie, time to partial or complete loss of restoration) 
 fracture grade at 6 months and 12 months 
 marginal adaptation grade at baseline, 6 months, and 12 months  
 approximal anatomical form (contact point) grade at baseline, 6 months, 12 months, and 
24 months 
 incidence of recurrent caries at 6 months, 12 months, and 24 months 
 marginal staining grade at baseline, 6 months, 12 months, and 24 months 
 surface staining grade at baseline, 6 months, 12 months, and 24 months 
 color match and translucency grade at baseline, 6 months, 12 months, and 24 months 
 surface luster grade at baseline, 6 months, 12 months, and 24 months 

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 postoperative hypersensitivity and tooth vitality grade at 6 months, 12 months, and 24 
months 
These endpoints will be summarized using descriptive statistics. The Wilcoxon signed-rank test 
will be used to compare outcomes consisting of continuous data at each of the time points. 
McNemar (or Cochran-Mantel-Haenszel) test will be used to compare outcomes consisting of 
categorical data at each of the time points. Time to restoration failure is defined as the time 
between the restoration date and the first report of the presence of restoration failure. Censored 
observations will include surviving restorations at the date of last follow-up or completely 
random drop-outs. To account for multiple observations measured from the same Subjects and 
assume the underlying statistical assumptions are met, a marginal Cox model33, 34 utilizing a 
robust sandwich covariance matrix estimate will be fitted to compare restoration retention 
survival time between the two adhesives. 
7.4.4 
Analysis of Safety Endpoint 
The incidence of treatment-related adverse events throughout the study will be summarized 
using descriptive statistics per study arm. 
7.5 
PLANNED INTERIM ANALYSES AND CRITERIA FOR CLINICAL INVESTIGATION 
A full interim analysis will be conducted when the minimum number of FAS Subjects (Section 
7.2) have completed the 12-month follow-up assessments. After all Subjects in the FAS have 
completed baseline and 6-month follow-up assessments, descriptive statistics will be generated. 
The result from the interim analysis will be used for generating a formal interim report. Given 
there is one full interim analysis, the O'Brien Fleming adjusted type I error rate of α = 0.005, 
0.048 for statistical significance will be used in the analyses conducted at 12 months and 
24 months respectively.35, 36 
7.6 
PROCEDURES FOR MISSING, UNUSED OR SPURIOUS DATA 
Missing data will be displayed as missing, whereas Subjects whose data are not available (ie, 
“not reported”, “N/A” or “not available”) will be considered as a separate category and 
presented in the reports. Restoration failure will be information carried forward and will impact 
the calculation of retention rate at each subsequent visit, whereas all other endpoints under 
consideration that are missing will be imputed using the time-specific treatment mean for that 
endpoint. 
7.7 
PROCEDURES FOR REPORTING DEVIATIONS FROM STATISTICAL PLAN 
Any deviations from the planned statistical analyses described in the CIP will be documented 
in the final report. 

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7.8 
VALIDATION PLAN 
Validation of the statistical programs, output and result for interim and final analyses will be 
performed by an independent Biostatistician. The Biostatistician will also review the statistical 
section of the Clinical Study Report for completeness and correct interpretations of the analysis 
results and provide comments.  
8. 
DATA MANAGEMENT 
Data collected for this study will be analyzed and stored at 3M or by an approved supplier for 
use by researchers including those outside of the study. Permission to transmit, store and use 
data outside of the study will be included in the informed consent. 
8.1 
DATA COLLECTION AND MANAGEMENT RESPONSIBILITIES 
Data collection is the responsibility of the clinical study staff at the site under the supervision 
of the site Investigator. The Investigator is responsible for ensuring the accuracy, completeness, 
legibility, and timeliness of the data reported. 
All source documents should be completed in a neat, legible, permanent (ie, non-editable) 
manner to ensure accurate interpretation of data. Data recorded in the electronic case report 
form (eCRF) derived from source documents must be consistent with the data recorded on the 
source documents.  
All data, including AEs and expected adverse event data, will be entered into a 21 CFR Part 
11-compliant data capture system provided by the Sponsor. The data system includes password 
protection and internal quality checks, such as automatic range checks, to identify data that 
appear inconsistent, incomplete, or inaccurate. 
The Sponsor is responsible for compilation and verification of the clinical study data, retention 
of the clinical study database, performance of statistical analysis, and preparation of the clinical 
study report. 
8.2 
STUDY RECORDS RETENTION 
The study participant’s information will be securely stored at each clinical site for internal use 
during the study. At the end of the study, all records will continue to be kept in a secure location 
for as long a period as dictated by the reviewing IRB, Institutional policies, regulatory 
authorities, or Sponsor requirements, as outlined in the study contract. 
The Investigator is to contact the Sponsor prior to the destruction of any study records, and no 
records are to be destroyed without the written consent of the Sponsor. It is the responsibility 
of the Sponsor to inform the Investigator when these documents no longer need to be retained. 

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8.3 
SPONSOR OVERSIGHT 
The Investigator will allow access to clinical study records for periodic on-site or remote 
monitoring visits by a designated Sponsor representative, with the understanding that the 
representative is bound by professional secrecy and will not disclose the identity of any Subject 
or personal medical information. The representative will review eCRFs for completeness during 
monitoring visits and after the eCRFs are submitted; any discrepancies will be resolved with 
the Investigator or designee, as appropriate. The data will be entered into the clinical study 
database and verified for accuracy. 
In addition to on-site or remote monitoring, routine review of submitted study information will 
be conducted by the Sponsor to ensure compliance with the CIP. Items reviewed include but 
are not limited to adverse events, deviations, number of withdrawn/terminated Subjects, which 
all may impact the completion of the study. Appropriate measures may be taken to ensure 
Investigator compliance with the CIP. 
9. 
AMENDMENTS TO THE CIP 
In the event that modifications to this CIP are necessary (eg, to protect the safety of the Subjects 
and/or the integrity of the data), the CIP will be amended and approved by the Sponsor. All 
changes will be evaluated for impact per the Sponsor's standard operating procedures (SOPs). 
In collaboration with the Investigator(s), the CIP modifications will then be documented and 
submitted for ethical and regulatory approval (as required) prior to implementation. 
Modifications will be considered implemented after all ethical and regulatory approvals (as 
required) are received and all key Sponsor personnel, Investigators, and Investigator designees, 
including key site staff, have been trained regarding the modified CIP.  
10. 
DEVIATIONS FROM THE CIP 
The Investigator is not allowed to deviate from the CIP except as specified in Section 5.6.4 of 
the International Standard, ISO/FDIS14155:2020(E). Briefly, deviations from the CIP to 
protect the rights, safety, and well-being of human subjects under emergency circumstances 
may proceed without prior approval of the Sponsor and the IRB; however, such deviations shall 
be documented and reported to the Sponsor and the IRB in accordance with IRB requirements. 
All deviations shall be documented on a deviation report form or appropriate CRF, and a 
deviation report form shall be completed for each event per individual Subject. The Investigator 
is responsible for reporting all deviations to the Sponsor and the reviewing IRB, per local 
requirements.  

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10.1 
DEVIATION REPORTING TIMELINES 
The timelines and methods for reporting the different types of deviations to the Sponsor are 
provided in Table 10.1-1. 
Table 10.1-1: Timeline and method for reporting deviations 
Type of Deviation 
Report to Sponsor 
Method 
Subject safety, rights, or welfare; OR 
Data integrity; OR 
Compromise the statistical analysis of 
the study; OR 
Lack of Informed Consent; OR 
Inclusion/Exclusion 
Within 24 hours of 
study staff becoming 
aware of event 
Initial: Phone/Email to 
Sponsor 
Complete CRF 
All other protocol deviations 
Per protocol visits 
Complete CRF 
11. 
DEVICE ACCOUNTABILITY 
The device(s) under investigation and additional study-specific devices and equipment to be 
used in both arms of the study (listed in Table 11-1) will not be distributed to the investigational 
site until all agreements between the site and 3M are finalized and IRB approval has been 
obtained. 3M requires that Investigators maintain device accountability and security of the 
devices at all times. The Investigator or designee will:  
 Maintain and account for devices at the Investigator site, including: 
o the name(s) of person(s) who received, used, returned, or disposed of the device; 
o the date of receipt, identification, and quantity of each investigational device 
(batch number/serial number or unique code); 
o the expiration date of the device, if applicable. 
 Keep devices in a secure storage area, accessible only to authorized individuals. 
 Dispense devices only to Subjects properly enrolled in and eligible for the study, 
including the following: 
o Subject identification; 
o the date or dates of use; 
o the date on which the investigational device was returned/explanted from 
Subject, if applicable. 

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 Return all unused investigational materials to the Sponsor at the end of the study or 
dispose of as agreed upon, including: 
o the date of return of unused, expired, or malfunctioning investigational devices, 
if applicable; 
o the date and documentation of disposal of the investigational devices as per 
instructions of the Sponsor, if applicable. 
The Sponsor shall have instructions in place and make packaging materials available, if 
applicable, for the safe return or disposal of investigational devices. 
Table 11-1: Device Information 
Device Name 
Type of Product
Catalogue 
Number 
3M™ Scotchbond™ Universal Plus 
Dental Adhesive 
(new) 
41297  
3M™ Scotchbond™ Universal  
Dental Adhesive 
(control) 
41254 
3M™ Filtek™ Universal Restorative 
Filling material  
6555 (syringe)  
6550 (capsule)
3M™ Sof-Lex Diamond Polishing System 
Pre-polishing 
and polishing 
5092 
3M™ Sof-Lex Extra-Thin Contouring and 
Polishing Discs 
Finishing and 
polishing 
XT 
3M™ Vitrebond™ Plus Light Cure Glass Ionomer 
Liner & Base 
Liner 
7572  
3M™ Elipar™ Deep Cure-S Curing Light 
Light curing 
device 
76976  
Colgate™ Cavity Protection Toothpaste or 
Crest™ Cavity Protection Toothpaste 
Toothpaste 
 
11.1 
DEVICE LABELING 
The devices under investigation will be labeled according to applicable regulations. A sample 
label will be retained, along with other study-related documents, at the site (eg, in the 
Investigator Site File). 

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11.2 
ADDITIONAL STUDY-SPECIFIC EQUIPMENT/DEVICE(S) 
Additional study-specific equipment/devices used in this study shall be maintained, calibrated 
(if applicable) and ensured to be functioning correctly during the study, in accordance with this 
study CIP or applicable site policy and regulatory requirements. The Sponsor should be notified 
of any anticipated or known issues with the device functionality that may impact the study 
conduct or outcome. 
12. 
STATEMENTS OF COMPLIANCE  
12.1 
ETHICAL CONSIDERATIONS 
This study will be conducted in accordance with ethical principles founded in the Declaration 
of Helsinki. In addition, this clinical investigation shall be conducted in accordance with ISO- 
14155:2011 and future versions, US FDA 21 CFR parts 812, 50, 54, 56, and any regional or 
national regulations, as appropriate.  
Approving IRBs will be provided all relevant study documentation in order to safeguard the 
rights, safety, and well-being of Subjects as mandated. The participating Investigator will obtain 
IRB approval of the study prior to initiation of the study at the site. The protocol, Instructions 
for Use, informed consent, written information given to Subjects, safety updates, and any 
revisions to these documents will be provided to the IRB by the Investigator. 
12.2 
PERIODIC REVIEWS 
Ongoing reviews by IRB are required for the duration of the clinical study. The Investigator 
will comply with IRB requirements for ongoing reviews, at a minimum annually.  
12.3 
PARTICIPANT CONFIDENTIALITY 
Participant confidentiality and privacy is strictly held in trust by the participating Investigators, 
their staff, and the Sponsor(s) and their authorized representatives. Information collected about 
Subjects during the study will be kept confidential and managed according to the requirements 
of the IRB and Health Insurance Portability and Accountability Act of 1996 (HIPAA). This 
confidentiality is extended to cover all clinical information relating to participants. Therefore, 
the Clinical Investigation Plan, documentation, data, and all other information generated will 
be held in strict confidence. No information concerning the study, or the data will be released 
to any unauthorized third party without prior written approval of the Sponsor.  
In the event that a Subject revokes authorization to collect or use Personal Health Information 
(PHI), the Investigator retains the ability to use all information collected prior to the revocation 
of Subject authorization. 

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Study data, which is for purposes of statistical analysis and scientific reporting, will be 
transmitted to and stored at 3M or approved supplier. This will not include the participant’s 
contact or identifying information. Rather, individual participants and their research data will 
be identified by a unique study identification number (see Section 6.4.2). The electronic data 
capture system used by clinical sites and by 3M research staff will be secured and password 
protected. At the end of the study, all study databases will be archived at 3M. 
12.4 
CONFLICT OF INTEREST 
The independence of this study from any actual or perceived influence, such as by the medical 
device industry, is critical. Therefore, any actual conflict of interest of persons who have a role 
in the design, conduct, analysis, publication, or any aspect of this trial will be disclosed and 
managed. Furthermore, persons who have a perceived conflict of interest will be required to 
have such conflicts managed in a way that is appropriate to their participation in the design and 
conduct of this trial. 
IRB/EC procedures should have provisions that the IRB/EC avoids any bias and conflict of 
interest, including proof of independent review of Sponsor-Investigator clinical investigations. 
The Sponsor can request that the IRB document that persons with conflict of interest or potential 
bias (eg, members of the investigation site team) were not part of the voting. 
The Sponsor has established procedures for all Investigators to disclose all conflicts of interest 
and will establish a mechanism for the management of all reported dualities of interest. The 
Sponsor will receive disclosures of conflict of interest from the PI prior to commencing the 
clinical investigation. 
12.5 
INSURANCE 
The Sponsor shall provide clinical study-related insurance covering the reasonable and 
necessary costs of diagnostic, therapeutic, and medical treatment including hospitalization costs 
(treatment costs) for such participant injuries following the administration or use of the study 
device(s) in accordance with this clinical investigational plan and in accordance with the 
national regulations. 
The Sponsor may reimburse the institution and/or study participants for treatment costs 
depending on who incurred such treatment costs. The Sponsor will not be responsible for paying 
for or reimbursing treatment costs if (i) the injury is attributable to the negligence or misconduct 
of any agent or employee of the institution or Investigator, or the failure of such persons to 
comply with a study protocol, (ii) the treatment costs are covered by the study participant’s 
medical or hospital insurance coverage, or (iii) the treatment costs arose as a result of the 
treatment of normal progression of the study participant’s disease or injuries resulting from 

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interventions that the study participants would have incurred had they not participated in the 
study. 
13. 
ADVERSE EVENTS, ADVERSE DEVICE EFFECTS, AND DEVICE 
DEFICIENCIES  
Investigators are responsible for ensuring that all safety events are recorded in the Subject 
record(s). Events defined in Section 13.1 will be reported to the Sponsor, as applicable, per the 
timelines in Section 13.3. 
13.1 
SAFETY AND EVENT REPORTING DEFINITIONS 
This study utilizes the terms and definitions related to safety and event reporting listed in 
Table 13.1-1 below. 
Table 13.1-1: Safety Definitions 
Term 
Definition 
Adverse Event 
(AE) 
Any untoward medical occurrence, unintended disease or injury, or 
untoward clinical signs (including abnormal laboratory findings) in 
subjects, users, or other persons, whether or not related to the 
investigational medical device. 
Adverse Device 
Effect (ADE)  
An adverse event related to the use of an investigational medical 
device. This includes any adverse events resulting from insufficient or 
inadequate instructions for use, deployment, implantation, installation, 
or operation, or any malfunction of the investigational medical device. 
This includes any event that is a result of a user error or intentional 
misuse of the investigational device.  
Serious Adverse 
Event (SAE) 
Any adverse event that: 
 Led to death 
 Led to serious deterioration in the health of the subject, that 
either resulted in 
o a life-threatening illness or injury 
o a permanent impairment of a body structure or a body 
function 
o in-patient or prolonged hospitalization 
o medical or surgical intervention to prevent life-threatening 
illness or injury or permanent impairment to a body 
structure or a body function 

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Term 
Definition 
 Led to fetal distress, fetal death or a congenital anomaly or 
birth defect  
Serious Adverse 
Device Effect 
(SADE)  
An adverse device effect that has resulted in any of the consequences 
characteristic of a serious adverse event 
Unanticipated 
Serious Adverse 
Device Effect 
(USADE)  
A serious adverse device effect, which by its nature, incidence, 
severity, or outcome has not been identified in the current version of 
the risk analysis report 
Device Deficiency 
(DD)  
An inadequacy of a medical device with respect to its identity, quality, 
durability, reliability, safety, or performance, such as malfunctions, use 
errors, and inadequate labelling 
Complaint  
Any written, electronic, or oral communication that alleges 
deficiencies related to the identity, quality, durability, reliability, 
safety, effectiveness, or performance of a device after it is released for 
distribution 
13.2 
CLASSIFICATION OF EVENTS 
13.2.1 
Severity Ratings 
The severity ratings for events are defined in Table 13.2.1-1. The Investigator shall ensure 
rating of reportable events on the applicable Case Report Form. 
Table 13.2.1-1: Severity Ratings Definitions 
Term  
Definition 
Mild 
An event that is easily tolerated by the subject, causing minimal 
discomfort, and not interfering with everyday activities 
Moderate 
An event that is sufficiently discomforting to interfere with normal 
everyday activities 
Severe 
An event that prevents normal everyday activities 
13.2.2 
Relatedness to Study Treatment 
Table 13.2.2-1 defines the relatedness definitions for events. The Investigator shall ensure rating 
of reportable events on the applicable Case Report Form. 

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Table 13.2.2-1: Relatedness Definitions 
Term  
Definition 
Not Related 
Relationship to the device or procedure can be excluded 
Possible 
Relationship with the use of the study device is weak but cannot be 
ruled out completely. 
Causal 
The event is associated with the study device or with the procedures 
beyond a reasonable doubt when: 
 The event is a known side effect of the device 
 The event has a temporal relationship with the study 
device/application procedures 
 The event involves a body/site or organ that 
o The device or procedures are applied to; 
o The device or procedures have an effect on 
 The event follows a known response pattern to the device 
13.3 
REPORTING TIMELINES 
Table 13.3-1 below indicates the reporting timelines and methods for reporting different types 
of AEs to the Sponsor. The Investigator shall also report Events to IRB/EC and local regulatory 
authorities, per local requirements. Reporting to Sponsor begins when study staff are aware of 
the event. For any event listed in the Table 13.3-1 below, the study Sponsor may request 
additional information from the Investigator, including but not limited to medical records, 
laboratory testing, or radiological results regarding the event. 
Table 13.3-1. Methods and Times for Reporting Safety Events.  
Type of event 
Report to Sponsor 
Method 
Adverse Events (AE) deemed by 
the Investigator to be related to 
participation in the study and 
considered to be due to the study 
intervention or comparator product. 
Per protocol visits 
Complete CRF 
Unanticipated Adverse Device 
Effect (UADE) 
Per protocol visits 
Complete CRF 
Serious Adverse Event 
(SAE)/Serious Adverse Device 
Effect (SADE) 
Within 24 hours of 
study staff becoming 
aware of event 
Initial: Phone/Email to 
Sponsor 
Followed by: Complete CRF 

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Type of event 
Report to Sponsor 
Method 
Unanticipated Serious Adverse 
Device Effect (USADE) 
Within 24 hours of 
study staff becoming 
aware of event 
Initial: Phone/Email to 
Sponsor 
Followed by: Complete CRF 
Device Deficiency (DD) 
Within 3 business 
days of becoming 
aware of event 
Complete CRF 
Product Complaints on 3M 
Marketed Product 
Within 3 business 
days of becoming 
aware of event 
Complete CRF 
13.4 
DETAILS CONCERNING SAFETY RECORDING AND REPORTING REQUIREMENTS 
13.4.1 
Investigator 
It is the responsibility of each participating Investigator to ensure all safety events (eg, AEs, 
SAEs, device effects, or DDs) are recorded in the Subject’s record. The collection/reporting 
period for safety events will begin after the teeth of the Subject have been randomized. 
Investigators should assess for AEs at each visit, and study Subjects should be instructed to 
report any AE that they experience to the Investigator. 
All AEs, regardless of perceived relationship to study product, will be documented in a timely 
manner and reported according to the methods and timelines in Section 13.3. In addition, the 
worsening of an underlying medical condition should also be recorded as an AE.  
The AE description will include the nature of the experience (AE term), the start date, the end 
date, the severity of each sign or symptom, the seriousness of the event or experience, 
relationship to study treatment, the course of action taken, and the outcome of the experience. 
It will be indicated if the AE caused the Subject to be discontinued from the study. 
Any AEs that are ongoing at the end of the study but are not safety-related should be marked as 
“persistent’ per the study-specific CRF. Any Events which are related to safety OR are 
persistent and deemed related to the study device should be followed for up to an additional 30 
calendar days or stabilization. Events reported by Subjects after the last study visit may be 
reported to the Sponsor up to 30 calendar days from the date of the last visit.  
13.4.2 
Sponsor 
Safety oversight will be under the direction of the Dental Director(s) of 3M, which is composed 
of individuals with the appropriate expertise. The Dental Director(s) routinely reviews and 
assesses the safety data of the study. Emergency contact information for reporting SAEs or 

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SADEs will be provided to the Investigator or Investigator designee, as well as the IRB, before 
initiating the study. 
The Sponsor will conduct an evaluation of the received AEs and if an event is confirmed to be 
a SAE/UADE, will report the results of the evaluation to all regulatory agencies overseeing the 
project and to participating Investigators. If the Sponsor determines that the event presents an 
unreasonable risk to the study Subjects, the Sponsor will terminate all clinical studies or parts 
of studies presenting risk as soon as possible. 
13.5 
ANTICIPATED ADVERSE EVENTS AND ADVERSE DEVICE EFFECTS 
Scotchbond™ Universal Plus Adhesive contains substances that may cause an allergic reaction 
by skin contact in certain individuals. To mitigate this potential adverse event, Subjects with a 
known allergy to acrylate will be excluded. In addition, the time of contact between the 
adhesive, especially uncured adhesive, and the Subject's oral soft tissue will be minimized. If 
prolonged contact with oral soft tissue occurs, the region will be flushed with large amounts of 
water. 
14. 
VULNERABLE POPULATION 
This study is intended to be conducted using a non-vulnerable population between the ages of 
18-years old and 70-years old with no expectations of benefits associated with participation or 
of retaliatory response from senior members of a hierarchy in case of refusal to participate. In 
addition, the study includes only Subjects that are capable of providing informed consent. 
However, the study does not exclude economically/educationally disadvantaged persons. The 
protection of rights, well-being, and safety of vulnerable populations is the most important 
consideration and should take precedent over the interests of the study. In addition, the 
protection of rights, well-being, and safety of vulnerable populations, and ascertaining 
appended safeguards, are the prerogative of the IRB, and the Investigator should comply with 
all institutional guidelines related to vulnerable populations.  
In recruitment process, the Investigator will ensure that Subject recruitment is free from 
pressure and will respect the Subject’s expectations of privacy. Participation will be presented 
as a voluntary option. In addition, the screening process will contain procedures to assess the 
pregnancy status of females of childbearing age as well as the decisional capacity of potential 
study Subjects. The study will be described to all potential Subjects by the Investigator in non-
technical terms, and the ICF will be written in an essentially non-technical manner to suit the 
solicited community. The study will be presented in a manner that permits ample time for 
consideration of participation, with no undue pressure related to the timing of the request. 

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Lastly, it is not anticipated that any special dental/medical care will be needed for any Subject 
enrolled for the study.  
15. 
SUSPENSION OR PREMATURE TERMINATION OF THE CLINICAL 
INVESTIGATION PLAN 
Both the Sponsor and the PI reserve the right to terminate the clinical investigation at any time. 
Should this be necessary, procedures will be arranged on an individual basis after review and 
consultation by both parties. If the study is terminated prematurely or suspended, study Subjects 
and the IRB will be informed promptly and provided with the reason(s) for the termination or 
suspension by the Sponsor or by the Investigator. If applicable, regulatory authorities and the 
personal dentist of the Subjects will also be informed. In terminating the clinical investigation, 
the 3M study team personnel and the PI will assure that adequate consideration is given to the 
protection of the Subjects' interests. 
This study may be suspended or prematurely terminated if there is sufficient reasonable cause. 
Written notification, documenting the reason for study suspension or termination, will be 
provided by the suspending or terminating party to all study participants, participating 
Investigators, IRB and regulatory authorities, and the Sponsor. If the study is prematurely 
terminated or suspended, the PI will promptly inform study participants, the IRB, and Sponsor 
and will provide the reason(s) for the termination or suspension. Study participants will be 
contacted, as applicable, and be informed of changes to study visit schedule. 
Circumstances that may warrant termination or suspension include, but are not limited to: 
 Determination of unexpected, significant, or unacceptable risk to participants 
 Demonstration of efficacy that would warrant stopping 
 Insufficient compliance to Clinical Investigation Plan requirements 
 Data that are not sufficiently complete and/or evaluable 
 Determination that the primary endpoint has been met 
 Determination of futility 
Suspended studies may resume once concerns about safety, Clinical Investigation Plan 
compliance, and data quality are addressed, and satisfy the Sponsor, IRB/EC and regulatory 
authorities. 

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15.1.1 
By Sponsor 
The Sponsor reserves the right to discontinue the clinical study for business or ethical reasons 
at any time, such as, but not limited to: 
 Information regarding the study product causes doubt as to the benefit/risk ratio 
 Changes in medical practice limit utility of the data obtained from the study 
 Investigator(s) lack of compliance with the approved CIP, lack of oversight, and/or not 
following applicable regulatory or IRB/EC guidelines in conducting the study 
 Incidence or severity of AEs indicates a potential health hazard or poses an unreasonable 
risk to the study participants 
 Subject enrollment is unsatisfactory 
 Fraud or misconduct 
15.1.2 
By IRB 
The IRB/EC may choose to discontinue the study at the site for which they granted approval. 
If the IRB/EC discontinues the study, the Investigator will report a withdrawal of IRB/EC 
approval to the study Sponsor within five (5) working days. 
16. 
REGISTRATION AND PUBLICATION POLICY 
16.1 
PUBLIC REGISTRATION 
The Sponsor shall ensure that this study will comply with any required national registration 
requirements. This study will be conducted in accordance with the applicable publication and 
data sharing policies and regulations. A description of this study will be available on 
http://www.ClinicalTrials.gov, as required by U.S. law. This website will not include 
information that identifies Subjects. At most, the website will include a summary of the results 
of the study and will be available for public review at any time. 
16.2 
PUBLICATIONS RESULTING FROM STUDY 
When applicable, attempts will be made to publish the results of the study, and a publication 
policy for this study will be addressed in a separate agreement between the PI and the Sponsor. 
17. 
BIBLIOGRAPHY 
1. 
Jeong, C.; Jeong, D., Must-know classifications of dental caries for the national dental 
hygiene boards. Dentistry iQ May 14th, 2016, 2016, pp 1-6. 

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2. 
Stewart, C. A.; Finer, Y., Biostable, antidegradative and antimicrobial restorative 
systems based on host-biomaterials and microbial interactions. Dent Mater 2019, 35 (1), 36-
52. 
3. 
Moraschini, V.;  Fai, C. K.;  Alto, R. M.; Dos Santos, G. O., Amalgam and resin 
composite longevity of posterior restorations: A systematic review and meta-analysis. J Dent 
2015, 43 (9), 1043-1050. 
4. 
Opdam, N. J.;  van de Sande, F. H.;  Bronkhorst, E.;  Cenci, M. S.;  Bottenberg, P.;  
Pallesen, U.;  Gaengler, P.;  Lindberg, A.;  Huysmans, M. C.; van Dijken, J. W., Longevity of 
posterior composite restorations: a systematic review and meta-analysis. J Dent Res 2014, 93 
(10), 943-9. 
5. 
Kopperud, S. E.;  Tveit, A. B.;  Gaarden, T.;  Sandvik, L.; Espelid, I., Longevity of 
posterior dental restorations and reasons for failure. Eur J Oral Sci 2012, 120 (6), 539-48. 
6. 
Opdam, N. J.;  Bronkhorst, E. M.;  Loomans, B. A.; Huysmans, M. C., 12-year 
survival of composite vs. amalgam restorations. J Dent Res 2010, 89 (10), 1063-7. 
7. 
De Munck, J.;  Van Landuyt, K.;  Peumans, M.;  Poitevin, A.;  Lambrechts, P.;  
Braem, M.; Van Meerbeek, B., A critical review of the durability of adhesion to tooth tissue: 
methods and results. J Dent Res 2005, 84 (2), 118-32. 
8. 
Baracco, B.;  Perdigao, J.;  Cabrera, E.; Ceballos, L., Two-year clinical performance 
of a low-shrinkage composite in posterior restorations. Oper Dent 2013, 38 (6), 591-600. 
9. 
Carvalho, A. A.;  Leite, M. M.;  Zago, J. K. M.;  Nunes, C.;  Barata, T. J. E.;  Freitas, 
G. C.;  Torres, E. M.; Lopes, L. G., Influence of different application protocols of universal 
adhesive system on the clinical behavior of Class I and II restorations of composite resin - a 
randomized and double-blind controlled clinical trial. BMC Oral Health 2019, 19 (1), 252. 
10. 
Perdigao, J.;  Dutra-Correa, M.;  Anauate-Netto, C.;  Castilhos, N.;  Carmo, A. R.;  
Lewgoy, H. R.;  Amore, R.; Cordeiro, H. J., Two-year clinical evaluation of self-etching 
adhesives in posterior restorations. J Adhes Dent 2009, 11 (2), 149-59. 
11. 
Sundfeld, R. H.;  Scatolin, R. S.;  Oliveira, F. G.;  Machado, L. S.;  Alexandre, R. S.; 
Sundefeld, M. L., One-year clinical evaluation of composite restorations in posterior teeth: 
effect of adhesive systems. Oper Dent 2012, 37 (6), E1-8. 
12. 
Vinagre, A.;  Ramos, J.;  Marques, F.;  Chambino, A.;  Messias, A.; Mata, A., 
Randomized clinical trial of five adhesive systems in occlusal restorations: One-year results. 
Dent Mater J 2020, 39 (3), 397-406. 
13. 
Balkaya, H.;  Arslan, S.; Pala, K., A randomized, prospective clinical study evaluating 
effectiveness of a bulk-fill composite resin, a conventional composite resin and a reinforced 
glass ionomer in Class II cavities: one-year results. J Appl Oral Sci 2019, 27, e20180678. 
14. 
Bayne, S. C.; Schmalz, G., Reprinting the classic article on USPHS evaluation 
methods for measuring the clinical research performance of restorative materials. Clin Oral 
Investig 2005, 9 (4), 209-14. 
15. 
Hickel, R.;  Peschke, A.;  Tyas, M.;  Mjor, I.;  Bayne, S.;  Peters, M.;  Hiller, K. A.;  
Randall, R.;  Vanherle, G.; Heintze, S. D., FDI World Dental Federation: clinical criteria for 
the evaluation of direct and indirect restorations-update and clinical examples. Clin Oral 
Investig 2010, 14 (4), 349-66. 

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16. 
Canali, G. D.;  Ignacio, S. A.;  Rached, R. N.; Souza, E. M., One-year clinical 
evaluation of bulk-fill flowable vs. regular nanofilled composite in non-carious cervical 
lesions. Clin Oral Investig 2019, 23 (2), 889-897. 
17. 
Haak, R.;  Hahnel, M.;  Schneider, H.;  Rosolowski, M.;  Park, K. J.;  Ziebolz, D.; 
Hafer, M., Clinical and OCT outcomes of a universal adhesive in a randomized clinical trial 
after 12 months. J Dent 2019, 90, 103200. 
18. 
Lawson, N. C.;  Robles, A.;  Fu, C. C.;  Lin, C. P.;  Sawlani, K.; Burgess, J. O., Two-
year clinical trial of a universal adhesive in total-etch and self-etch mode in non-carious 
cervical lesions. J Dent 2015, 43 (10), 1229-34. 
19. 
Lenzi, T. L.;  Pires, C. W.;  Soares, F. Z. M.;  Raggio, D. P.;  Ardenghi, T. M.; de 
Oliveira Rocha, R., Performance of Universal Adhesive in Primary Molars After Selective 
Removal of Carious Tissue: An 18-Month Randomized Clinical Trial. Pediatr Dent 2017, 39 
(5), 371-376. 
20. 
Loguercio, A. D.;  de Paula, E. A.;  Hass, V.;  Luque-Martinez, I.;  Reis, A.; Perdigao, 
J., A new universal simplified adhesive: 36-Month randomized double-blind clinical trial. J 
Dent 2015, 43 (9), 1083-1092. 
21. 
Mena-Serrano, A.;  Kose, C.;  De Paula, E. A.;  Tay, L. Y.;  Reis, A.;  Loguercio, A. 
D.; Perdigao, J., A new universal simplified adhesive: 6-month clinical evaluation. J Esthet 
Restor Dent 2013, 25 (1), 55-69. 
22. 
Munoz, M. A.;  Luque, I.;  Hass, V.;  Reis, A.;  Loguercio, A. D.; Bombarda, N. H., 
Immediate bonding properties of universal adhesives to dentine. J Dent 2013, 41 (5), 404-11. 
23. 
Olegario, I. C.;  Hesse, D.;  Bonecker, M.;  Imparato, J. C. P.;  Braga, M. M.;  Mendes, 
F. M.; Raggio, D. P., Effectiveness of conventional treatment using bulk-fill composite resin 
versus Atraumatic Restorative Treatments in primary and permanent dentition: a pragmatic 
randomized clinical trial. BMC Oral Health 2017, 17, 34. 
24. 
Perdigao, J.;  Ceballos, L.;  Giraldez, I.;  Baracco, B.; Fuentes, M. V., Effect of a 
hydrophobic bonding resin on the 36-month performance of a universal adhesive-a 
randomized clinical trial. Clin Oral Investig 2020, 24 (2), 765-776. 
25. 
Perdigao, J.;  Kose, C.;  Mena-Serrano, A. P.;  De Paula, E. A.;  Tay, L. Y.;  Reis, A.; 
Loguercio, A. D., A new universal simplified adhesive: 18-month clinical evaluation. Oper 
Dent 2014, 39 (2), 113-27. 
26. 
Shinohara, M. S.;  Carvalho, P. R. M.;  Neves Marcon, L.;  Goncalves, D. F. M.;  
Ramos, F. S. E.; Fagundes, T. C., Randomized clinical trial of different adhesion strategies in 
noncarious cervical lesion restorations: 1-year follow-up. Quintessence Int 2020, 51 (5), 352-
363. 
27. 
Souza, M. Y.;  Jurema, A. L. B.;  Caneppele, T. M. F.; Bresciani, E., Six-month 
performance of restorations produced with the ethanol-wet-bonding technique: a randomized 
trial. Braz Oral Res 2019, 33, e052. 
28. 
Zanatta, R. F.;  Silva, T. M.;  Esper, M.;  Bresciani, E.;  Goncalves, S.; Caneppele, T., 
Bonding Performance of Simplified Adhesive Systems in Noncarious Cervical Lesions at 2-
year Follow-up: A Double-blind Randomized Clinical Trial. Oper Dent 2019, 44 (5), 476-
487. 

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29. 
de Paris Matos, T.;  Perdigao, J.;  de Paula, E.;  Coppla, F.;  Hass, V.;  Scheffer, R. F.;  
Reis, A.; Loguercio, A. D., Five-year clinical evaluation of a universal adhesive: A 
randomized double-blind trial. Dent Mater 2020. 
30. 
Demirci, M.;  Tuncer, S.; Yuceokur, A. A., Prevalence of caries on individual tooth 
surfaces and its distribution by age and gender in university clinic patients. Eur J Dent 2010, 
4 (3), 270-9. 
31. 
Association, A. D. Tooth-Colored Restorative Materials for Posterior Teeth; 2003. 
32. 
Manhart, J.;  Chen, H.;  Hamm, G.; Hickel, R., Buonocore Memorial Lecture. Review 
of the clinical survival of direct and indirect restorations in posterior teeth of the permanent 
dentition. Operative Dentistry 2004, 29 (5), 481-508. 
33. 
Lee, E. W.;  Wei, L. J.;  Amato, D. A.; Leurgans, S., Cox-Type Regression Analysis 
for Large Numbers of Small Groups of Correlated Failure Time Observations. In Survival 
Analysis: State of the Art, Kluwer Academic Publishers: 1992; pp 237-247. 
34. 
Lin, D. Y., Cox regression analysis of multivariate failure time data: the marginal 
approach. Stat Med 1994, 13 (21), 2233-47. 
35. 
Geller, N. L.; Pocock, S. J., Interim analyses in randomized clinical trials: 
ramifications and guidelines for practitioners. Biometrics 1987, 43 (1), 213-23. 
36. 
Piantadosi, S., Clinical trials: a methodologic perspective. John Wiley and Sons: New 
York, 1997; p 928. 
 
18. 
STUDY-SPECIFIC APPENDICES 
Appendix 
Title 
Appendix A American Society of Anesthesiologists (ASA) Physical Status Classification 
System
Appendix B
Grace & Smales Mobility Index
Appendix C
ICDAS Radiographic Scoring System 
Appendix D
Revision History 
 

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18.1 
APPENDIX A. AMERICAN ASSOCIATION OF ANESTHESIOLOGISTS (ASA) PHYSICAL STATUS CLASSIFICATION SYSTEM 
Last approved by the ASA House of Delegates on October 15, 2014, amended October 23, 2019 
ASA PS 
Classification  
Definition  
Examples, including, but not limited to:  
ASA I  
A normal healthy patient  
Healthy, non-smoking, no or minimal alcohol use  
ASA II  
A patient with mild systemic 
disease  
Mild diseases only without substantive functional limitations. Examples include (but not limited to): 
current smoker, social alcohol drinker, pregnancy, obesity (30<BMI<40), well- controlled DM/HTN, 
mild lung disease  
ASA III  
A patient with severe systemic 
disease  
Substantive functional limitations; One or more moderate to severe diseases. Examples include (but 
not limited to): poorly controlled DM or HTN, COPD, morbid obesity (BMI ≥40), active hepatitis, 
alcohol dependence or abuse, implanted pacemaker, moderate reduction of ejection fraction, ESRD 
undergoing regularly scheduled dialysis, premature infant PCA < 60 weeks, history (>3 months) of 
MI, CVA, TIA, or CAD/stents.  
ASA IV  
A patient with severe systemic 
disease that is a constant threat 
to life  
Examples include (but not limited to): recent (<3 months) MI, CVA, TIA, or CAD/stents, ongoing 
cardiac ischemia or severe valve dysfunction, severe reduction of ejection fraction, sepsis, DIC, ARD 
or ESRD not undergoing regularly scheduled dialysis  
ASA V  
A moribund patient who is not 
expected to survive without the 
operation  
Examples include (but not limited to): ruptured abdominal/thoracic aneurysm, massive trauma, 
intracranial bleed with mass effect, ischemic bowel in the face of significant cardiac pathology or 
multiple organ/system dysfunction  
ASA VI  
A declared brain-dead patient 
whose organs are being 
removed for donor purposes  
 
*The addition of “E” denotes Emergency surgery: 
(An emergency is defined as existing when delay in treatment of the patient would lead to a significant increase in the threat to life or body part)  

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18.2 
APPENDIX B. GRACE AND SMALES MOBILITY INDEX 
Grace & Smales Mobility Index: 
 Grade 0: No apparent mobility 
 Grade 1: Perceptible mobility < 1 mm in buccolingual direction 
 Grade 2: Mobility > 1 mm but < 2 mm buccolingually 
 Grade 3: Mobility > 2 mm buccolingually or depressibility in the socket 
 
 

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18.3 
APPENDIX C. ICDAS RADIOGRAPHIC SCORING SYSTEM  
 
 
 
 

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18.4 
APPENDIX D.   REVISION HISTORY  
 
Overall summary of changes 
Version 3.  Modified Marginal Gap Adaptation grading scale to eliminate probes.  Added additional 
detail to sample size determination and analysis of primary endpoints. 
Section 
modified 
Original text 
Updated text 
6.4.8.3 Marginal 
Adaptation 
2. Good: Marginal integrity deviates 
from the ideal but could be 
upgraded to ideal by polishing. 
Small marginal chip fracture of 
the restoration can be eliminated 
by polishing and/or a localized 
gap is just perceptible with a 
dental probe < 150 µm. Sub-
grading 
of 
good 
marginal 
adaptation should be applied as 
follows: 
a. Marginal gap (<150 µm), 
white lines. 
b. ... 
c. ... 
3. Sufficient/satisfactory: 
Leakage/discoloration is present 
but limited to the marginal area. 
Generalized marginal gap >150 
µm but <250 µm, is easily 
perceptible on probing but cannot 
be 
modified 
without 
minor 
damage 
to 
the 
tooth 
or 
surrounding tissue and is not 
considered to result in long-term 
negative consequences for the 
tooth or surrounding tissue if left 
untreated. Presence of several 
small marginal fractures that are 
unlikely 
to 
cause 
long-term 
effects. Sub-grading should be 
applied as follows: 
a. Gap < 250 µm not removable, 
no dentin exposure. 
b. ... 
c. ... 
2. Good: Marginal integrity deviates 
from the ideal but could be upgraded 
to ideal by polishing. Small marginal 
chip fracture of the restoration can be 
eliminated by polishing and/or a 
localized gap is just perceptible. Sub-
grading of good marginal adaptation 
should be applied as follows: 
a. Marginal gap, white lines. 
b. ... 
c. ... 
 
 
 
 
3. Sufficient/satisfactory: 
Leakage/discoloration is present but 
limited 
to 
the 
marginal 
area. 
Generalized marginal gap is easily 
perceptible 
based 
on 
clinical 
judgement and analysis of clinical 
photographs but cannot be modified 
without minor damage to the tooth or 
surrounding 
tissue 
and 
is 
not 
considered to result in long-term 
negative consequences for the tooth 
or surrounding tissue if left untreated. 
Presence of several small marginal 
fractures that are unlikely to cause 
long-term 
effects. 
Sub-grading 
should be applied as follows: 
a. Gap not removable, no dentin 
exposure. 
b. ... 
c. ... 
 

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Overall summary of changes 
Version 3.  Modified Marginal Gap Adaptation grading scale to eliminate probes.  Added additional 
detail to sample size determination and analysis of primary endpoints. 
Section 
modified 
Original text 
Updated text 
4. Unsatisfactory: Localized gap 
larger than 250 µm, may result in 
exposure of dentine or base. 
Repair 
is 
necessary 
for 
prophylactic 
reasons. 
Sub-
grading 
of 
unsatisfactory 
marginal adaptation should be 
applied as follows: 
a. Gap > 250 µm or dentine/base 
exposed. 
b. ... 
c. ... 
5. Poor: Generalized gap larger than 
250 µm or the restoration is loose 
but in situ, re-placement is 
necessary 
to 
prevent further 
damage 
or 
there 
are 
large 
fractures at the margins and loss 
of material is too extensive to be 
repaired.
 
4. Unsatisfactory: Localized major gap 
that may result in exposure of dentine 
or base. Repair is necessary for 
prophylactic reasons. Sub-grading of 
unsatisfactory marginal adaptation 
should be applied as follows: 
a. Major gap, dentine/base exposed. 
b. ... 
c. ... 
 
 
5. Poor: Generalized major gap or 
irregularities; or the restoration is 
loose but in situ. Replacement is 
necessary to prevent further damage 
or there are large fractures at the 
margins and loss of material is too 
extensive to be repaired. 
7.2 Sample Size 
Determination 
NA 
Added: 
In addition, the sample size of 100 
restorations (2 restorations per 
subject) will provide acceptable 
precision in estimating the overall 
restoration survival rate.  Given an 
expected annual restoration failure 
rate of 3.3%32, a one-sided 95% 
confidence interval will produce an 
upper confidence limit of 7.7%, 
using the Wilson score method. 
7.4.2 Analysis of 
Primary 
Endpoints 
Descriptive statistics will be used 
to summarize the primary 
endpoints for the two adhesive 
products using FAS with imputed 
endpoints. 
Descriptive statistics will be used to 
summarize the primary endpoints for 
overall and by the two adhesive 
products using FAS with imputed 
endpoints.