Clinical Investigation of a New Bulk Fill Composite Resin in the Restoration of Posterior Teeth
Phase: NA
Conditions: Dental Restoration Failure of Marginal Integrity, Dental Caries, Unrepairable Overhanging of Dental Restorative Materials, Poor Aesthetics of Existing Restoration, Secondary Dental Caries Associated With Failed or Defective Dental Restorations, Fractured Dental Restorative Materials Without Loss of Materials, Fracture of Dental Restorative Materials With Loss of Material
Sponsor: University of North Carolina, Chapel Hill

 
CLINICAL INVESTIGATION OF 
A NEW BULK FILL COMPOSITE RESIN 
IN THE RESTORATION OF POSTERIOR TEETH 
 
 
 
NCT number NCT02572570 
Document Date 03/20/2015 
 

CLINICAL INVESTIGATION OF 
A NEW BULK FILL COMPOSITE RESIN 
IN THE RESTORATION OF POSTERIOR TEETH 
 
Protocol 03/20/2015 
 
UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL 
DEPARTMENT OF OPERATIVE DENTISTRY 
 
Version 7 
 
 
PRINCIPAL INVESTIGATOR: 
 
Ricardo Walter, DDS, MS 
Clinical Associate Professor 
Department of Operative Dentistry 
University of North Carolina 
445 Brauer Hall, CB# 7450 
NC 27599-7450 
USA 
Tel: 919 537-3442 
Fax: 919 537-3990 
Email: walterr@unc.edu 
 
FUNDING: 
 
 
 
 
3M ESPE 
 
 
 
 
 
 
St. Paul, MN, USA 
 
 
ABSTRACT 
Polymerization shrinkage remains one of the primary disadvantages of composite resin 
restorative materials.  To minimize the effects of polymerization shrinkage and consequently 
allow clinicians to expedite the restorative treatment, the 3M ESPE company has developed a 
bulk fill composite resin called Filtek™ Bulk Fill Posterior Restorative.  This clinical trial is 
designed to evaluate the performance of the new composite resin in Class II restorations.  A 
conventional composite resin material, Filtek™ Supreme Ultra Universal Restorative, will be 
used as the control.  Restorations will be placed and evaluated using defined criteria at one, 
two, three, and five years after placement. 

 
 
2
INTRODUCTION 
Polymerization of resin-based composite resin restoratives leads to shrinkage of the material 
on setting.  Conversion of monomers to long chain polymers results in a reduction in volume 
as the material sets.  The clinical effects of this shrinkage can include postoperative 
sensitivity, marginal gap formation and leakage, cuspal strain, and microcracks in enamel 
[1,2].  Since Bowen noted polymerization shrinkage of resin bonded to etched enamel [3], 
much research has been carried out to gain understanding of the kinetics of polymerization 
shrinkage.  Polymerization stress of composite resins during light-curing is considered to be 
an important factor in bond failure of an adhesive restoration [2].  Recent work has shown 
that the effects of polymerization shrinkage stress on tooth structure are highly complex.  
With direct composite resins, stress levels in the tooth increase with increasing restoration 
size [4,5], stresses in the restoration itself, and at the adhesive interface, tending to diminish 
with increasing cavity size [5].  Clinical methods to reduce the effects of shrinkage stress 
include sealing the restoration margins with unfilled resin [6], using a stress-absorbing liner 
[7,8], using reduced light intensity for curing the composite resin restoration [9-11], and 
placing the composite resin in increments [12]. 
The desirability of a reduced shrinkage restorative material is widely acknowledged 
[2,13-15].  The potential advantages of a low shrink composite resin would include less stress 
on the adhesive bond, leading to better margin adaptation, a reduction in postoperative 
sensitivity, and reduced stress build-up in the tooth itself [15], all features that might lead to 
enhanced longevity of the restoration in clinical service. 
The continuing development of direct composite resin restoratives has resulted in the 
availability of a new material from 3M ESPE with significantly reduced polymerization 
shrinkage and shrinkage stress level. 
 
AIM OF STUDY 
The aim of this randomized, controlled clinical investigation is to evaluate the performance 
of 3M ESPE Filtek™ Bulk Fill Posterior Restorative composite resin in the restoration of 
moderate-sized Class II cavities in the permanent teeth of adult patients.  This material will 
be compared with Filtek™ Supreme Ultra Universal Restorative (3M ESPE), an established 
and widely used composite resin restorative material.  Restorations performed with both 
composite resins will be bonded with Scotchbond Universal Adhesive. 
Dr. Ricardo Walter of the Department of Operative Dentistry, University of North 
Carolina (UNC) will be the principal investigator (PI) with overall responsibility for the 
conduct and reporting of the study.  Dr. Walter and other Operative Dentistry personnel at 
UNC will undertake the clinical elements of the study.  The study will be of five years 
duration. 

 
 
3
ETHICAL STANDARDS 
The study will be conducted in accordance with the Declaration of Helsinki (1964) as revised 
in Venice in 1983.  IRB approval will be obtained prior to commencing the study and written 
informed consent will be obtained from all patients prior to recruitment into the study.  
Implicit in giving informed written consent, each patient will reserve the right to withdraw 
from the study at any time. 
 
RISK ASSESSMENT 
Filtek™ Bulk Fill Posterior Restorative is assessed as minimal risk.  There is no anticipated 
clinical benefit of use of Filtek™ Bulk Fill Posterior Restorative over conventional composite 
resin materials except for the reduced time needed for the restorative procedure. 
 
Filtek™ Bulk Fill Restorative is considered safe when used as indicated.  The 
biocompatibility assessment for the material has been conducted in accordance with the 
testing guidelines outlined in (1) the FDA General Program Memorandum G95; (2) ISO 
10993-1:2009(E) Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing 
within a Risk Management Process with detailed guidance in ISO Standards 10993-3:2003 
(Tests for Genotoxicity, Carcinogenicity and Reproductive Toxicity), 10993-5:2009 (Tests for 
In Vitro Cytotoxicity), 10993-10:2010 (Tests for Irritation and Skin Sensitization), and 
10993-11:2006 (Tests for Systemic Toxicity); (3) ISO 7405:2008 Dentistry – Evaluation of 
Biocompatibility of Medical Devices in Dentistry; (4) Japan: PFSB/ELD/OMDE Notification 
No. 0301-1 from March 1, 2012; and (5) 3M ESPE Standard Operating Procedure 04-200.  
Filtek™ Bulk Fill Posterior Restorative was assessed as an external communicating device 
that is intended to be in contact with the body for greater than 30 days (ISO 10933 and ISO 
7405, G95) and a coupling instrument between the inside and outside of the body (PFSB). 
The data from these tests support the view that Filtek™ Bulk Fill Posterior 
Restorative is safe for its intended use. 
 
PRECLINICAL TESTING 
Extensive laboratory testing has been carried out to compare Filtek™ Bulk Fill Posterior 
Restorative with other composite resin materials.  Filtek™ Bulk Fill Posterior Restorative 
compares favorably with Filtek™ Supreme Ultra Universal Restorative (the control material 
to be used in this study) for physical properties such as flexural modulus, fracture toughness, 
and flexural strength.  Further internal data has shown wear and cusp deflection comparable 
to 3M ESPE Filtek™ Z250 Universal Restorative.  In regards to the ability to light cure the 
composite resin in bulk, a study from Oregon Health Sciences University (unpublished 
“internal” data) has indicated that additional 10 s light curing from buccal and lingual allow 
Class II restorations to be placed in 5-mm increments.  That should improve the physical 

 
 
4
properties (microhardness) of the composite resin that otherwise has a depth of 
polymerization of approximately 4 mm (internal data). 
 
HYPOTHESIS TO BE TESTED 
The hypothesis is that Filtek™ Bulk Fill Posterior Restorative composite resin, when used to 
restore posterior teeth, will exhibit similar clinical performance – in terms of wear 
resistance, marginal integrity, durability, and other clinical characteristics – to Filtek™ 
Supreme Ultra Universal Restorative composite resin, a restorative material in everyday use 
in dentistry. 
 
STUDY OBJECTIVES 
The purpose of this study is to compare the clinical performance of Filtek™ Bulk Fill 
Posterior Restorative with a commercially available conventional composite resin restorative 
material when used to restore Class II preparations in molar and premolar teeth. 
 
STUDY DESIGN 
The study design is a randomized, controlled, comparative effectiveness clinical trial 
investigation of the test materials used to restore moderate-sized Class II cavities in posterior 
permanent teeth in adult dental patients.  The study will be of five years duration. 
 
Primary outcome measures 
The primary endpoint is the clinical performance of the restorations measured according to 
the rating system published by Hickel et al. [16]. 
 
In the past, USPHS (or Ryge) criteria have been used to evaluate the clinical 
performance of restorative materials.  These criteria were developed as a standardized 
method to clinically evaluate the quality of an amalgam or resin restoration shortly after 
placement.  The word “quality” means the degree of excellence or degree of conformance to a 
standard.  The rating system is based on an operational approach to quality assessment, 
which a dentist would use when examining any restoration in the mouth of a new patient.  
The dentist must decide whether to retain or replace the restoration [17]. 
 
This rating system has been in use for over 30 years of clinical investigation.  Because 
the clinical performance of restorative materials has continuously improved, the original 
Ryge criteria have been modified frequently, which makes it difficult to compare studies on 
modern restorative materials. 
 
Hickel et al. have offered a new approach to controlled clinical studies of restorative 
materials.  Their publication deals with, among other issues, an adaptation of the established 
Ryge-criteria of restorative materials [16].  With this rating system, which will be used in this 

 
 
5
study, restorations are evaluated scoring for their esthetic, functional and biologic 
properties. 
 
Secondary outcome measures 
All (serious) adverse events or (serious) adverse device effects will be documented on the 
appropriate “Adverse event/Adverse device effect form.”  Safety parameters of this clinical 
trial are predominantly based on the documentation of adverse events, serious or non-
serious, as well as expected and unexpected reactions.  Also, near incidents will be reported. 
 
SUBJECT POPULATION AND SAMPLE SIZE 
Subjects in the study will be recruited within the UNC School of Dentistry Predoctoral and 
Graduate clinics.  Up to 50 adult subjects (18 years of age and older) will be recruited to 
provide at least 50 sets of matched or unmatched paired teeth in need of study restorations.  
Fifty restorations available at baseline and 40 at the 18-month follow-up visit are the 
minimum number recommended in the 2001 ADA guidelines for clinical trials on resin-
based composite resins for posterior restorations.  Subjects will be in need of two or four 
medium-sized Class II restorations in molar and/or premolar teeth. 
 
INCLUSION AND EXCLUSION CRITERIA 
To be included in the study, a potential subject must satisfy the criteria described below and 
be available for the various follow-up visits.  A record will be maintained of the reasons for 
the loss of subjects from the study. 
 
Inclusion Criteria 
To be considered for inclusion in the study, subjects must: 
• 
Be older than 18 years of age. 
• 
Have a pair of similar lesions or failed restorations in vital permanent molar or 
premolar teeth requiring Class II restorations of moderate size that extend between 
one-quarter and one-third of the way up one or more of the cuspal slopes.  Any Class 
II restoration must have a proximal portion with at least one margin that obviously 
extends into an interproximal embrasure.  (Note: A tooth will be considered vital for 
the purposes of the study if it is clinically and/or radiographically free of any signs 
and symptoms of periapical pathology and responds to routine vitality testing.)   
• 
Be capable of giving written informed consent. 
 
Exclusion Criteria 
Subjects will be excluded from participating in the study if they: 

 
 
6
• 
Have a history of any adverse reaction to clinical materials of the types to be 
evaluated. 
• 
Have a medical or dental history that could possibly complicate the provision of the 
proposed restorations and/or influence the behavior and performance of the 
restorations in clinical service. 
• 
Have advanced periodontitis affecting the mobility of the teeth. 
• 
Have xerostomia caused by medications, Sjögren’s syndrome, etc.  
• 
Are individuals with special needs. 
 
Distribution of restorations 
Each subject shall have a minimum of one pair and a maximum of two pairs of permanent 
molar or premolar teeth requiring moderate sized Class II restorations.  No tooth shall 
require more than one restoration.  Sufficient subjects will be recruited to ensure 50 pairs of 
test and control study restorations are placed.  Although desirable, the pairs are not required 
to be precisely matched.  For example, for purposes of the study, paired restorations can be 
placed in teeth #15 and #31 (upper left second molar and lower right second molar).  
 
All teeth and restorations in the study will have occlusal contacts.  All restorations, 
with the exception of disto-occlusal restorations in the most distal molars, will have a 
proximal contact with the adjacent tooth.  No two test restorations of either material will be 
in occlusal or proximal contact with each other. 
 
Selection of Teeth 
In addition to the above criteria, the following will apply in tooth selection: 
• 
The tooth must be vital, as determined by thermal test (Hygenic Endo-Ice, 
Coltène/Whaledent AG). 
• 
The tooth must be of typical size, appearance and morphology. 
• 
The tooth must share, where appropriate, sound proximal contacts with adjacent 
teeth. 
• 
The tooth must be free of cracks and other defects and lesions necessitating operative 
intervention other than the restoration to be undertaken as part of the study. 
• 
Proper isolation must be possible. 
 
MATERIALS 
The test material is Filtek™ Bulk Fill Posterior Restorative, a bulk fill, low-shrink, light-
cured, radiopaque composite resin restorative indicated for use in direct posterior situations.  
The control material is Filtek™ Supreme Ultra Universal Restorative, a conventional 
composite resin.  Restorations will be bonded with Scotchbond Universal Adhesive. 

 
 
7
Manufacturers’ instructions for use will be followed for all restoration placements 
included in the study.  Manufacturers’ instructions for use for Filtek™ Supreme Ultra 
Universal Restorative and Filtek™ Bulk Fill Posterior Restorative, and Scotchbond Universal 
Adhesive are given in the Investigator’s Brochure. 
 
PRE-OPERATIVE PROCEDURES 
In the screening visit, written informed consent will be obtained from each subject.  Each 
subject will be allowed to ask questions concerning the evaluation and to consider the 
answers given before signing the consent form. 
The pre-operative status and a periapical radiograph (where clinically indicated) of 
each tooth to be included in the study will be evaluated and a pre-treatment status form will 
be completed (Patient Registration Form).  The condition of the gingival tissue adjacent to 
each tooth to be restored will be assessed (four sites: facial, lingual, mesial and distal) and 
recorded as pre-treatment measurements (Patient Registration Form).  Oral hygiene status 
including plaque index will be determined after periodontal evaluation.  Appropriate vitality 
and radiographic assessments will be completed where indicated clinically, and will be 
recorded.  A pre-operative photographic record will be made. 
The restorative material to be used will be allocated by means of a randomization 
scheme based on computer generated random numbers (Appendix 1).  Before starting the 
study, the PI will decide, by means of a toss of a coin, whether even or odd numbers indicate 
the test or control treatment.  For each set of paired teeth, the lowest numbered tooth 
(Universal Numbering System) will be selected first.  Before cavity preparation, the first 
randomization number in the sequence will be noted and the allocated treatment procedure 
carried out as indicated by the random number obtained.  The second cavity is then prepared 
and restored using the second treatment option (next number in the row).  Restorative 
treatments will be randomly assigned to the study teeth at the same visit at which pre-
treatment gingival condition, vitality, etc., are determined. 
The treating clinician will complete the preparation and placement of restorations, 
and the arrangements for the subsequent follow-up of the patients. 
 
OPERATIVE PROCEDURES 
Local anesthesia will be administered unless declined by the patient.  The teeth to be 
restored will be prepared using conventional instruments and techniques, and no bevels will 
be placed on any of the cavosurface margins.  Shades will be selected before the procedure is 
started and the tooth is still moist.  Rubber dam will be used. 
A sectional metal matrix (Garrison Dental or similar) and bitine ring will be placed 
along with plastic or wooden wedges.  At the operator’s discretion (e.g., if the preparation is 

 
 
8
too wide for a sectional matrix), a thin circumferential metal matrix (Convexi-T, Clinician’s 
Choice or similar) may be used.  The bonding system will be used in the selective etch mode 
according to manufacturer’s instructions. 
Restoration placement will be completed in accordance with the recommended 
procedure for the materials under investigation and in a standardized fashion.  After 
application of the adhesive, a bulk increment (up to 5 mm in thickness) of Filtek™ Bulk Fill 
Posterior Restorative will be placed and adapted with suitable instruments.  Additional 
increments will be placed as needed.  Filtek™ Supreme Ultra Universal Restorative will be 
incrementally placed in layers (no thicker than 2 mm).  The composite resin (each increment 
of Filtek™ Supreme Ultra Universal Restorative) will be light cured following the 
recommended exposure time using a device provided by the sponsor.  Additional light curing 
will be performed from facial and lingual for Filtek™ Bulk Fill Posterior Restorative after 
matrix removal per instructions for use. 
Excess material will be removed with suitable instrumentation.  Occlusion will be 
checked and adjusted as needed.  Restorations will be polished with diamond abrasives, 
flexible polishing discs and finishing strips with progressively decreasing grit size (e.g. Sof-
Lex™, 3M ESPE), ultra-fine grain diamonds, and/or silicone polishers at the clinicians’ 
discretion.  Impressions of restorations using the 3M True Definition Scanner and Imprint™ 
3 VPS Impression Material will be taken at each follow-up visit for evaluation of wear over 
time.  Models will be poured and wear determined using the Leinfelder method [18].  The 
models will also be assessed for wear via optical profiling at the Minnesota Dental Research 
Center for Biomaterials and Biomechanics.  Digital impressions of the restored teeth will be 
taken at each follow-up visit using the 3M True Definition Scanner.  The digital data will be 
analyzed for wear at 3M ESPE. 
The placements and baseline assessments will be completed within 6-12 months of 
the agreed starting date of the evaluation. 
 
FOLLOW-UP ASSESSMENT 
During the follow-up investigation, two examiners will evaluate the restorations relative to 
the criteria provided by Hickel.  The two examiners who undertake the reviews will work 
independently and will be masked to the treatment conditions.  In the event of disagreement 
between the examiners, agreement will be reached based on discussion.  The final result will 
be marked on the Case Report Form. 
 
To determine the clinical acceptability of the restoration they are evaluated scoring for 
their esthetic, functional and biologic properties, which are shown in Table 1.  The test requires 
a sharp explorer plus visual inspection, aided by a mouth mirror as needed.  A photographic 
record will be made of each restoration.  For evaluation of marginal adaptation a set of 

 
 
9
explorers with different blunt tips of 50, 150 and 250 µm is recommended by Hickel et al. [16]. 
For assessment of contact point metal strips of different thicknesses of 25 µm, 50 µm and 100 
µm can be used.  The explorers and metal strips will be provided by the sponsor. 
 
The two masked examiners will use a two-step approach for assigning scores for each 
parameter.  The first step is to assess the restoration and to determine the level of clinical 
acceptability for each parameter in each of the categories.  The result becomes unacceptable 
whenever re-treatment is necessary. 
 
If a parameter is judged to be acceptable, as a second step, a further distinction can 
be made between an excellent, good, or clinically satisfactory result.  Score 1 means that the 
quality of the restoration is excellent and fulfils all quality criteria and the tooth and/or 
surrounding tissues are adequately protected.  Score 2 should be selected when the quality of 
the restoration is still highly acceptable, although one or more criteria deviate from the ideal.  
The restoration could be modified by polishing and upgraded to an “excellent” rating, but 
this is not normally necessary.  There is no risk of damage to the tooth and/or surrounding 
tissue.  Score 3 means that the quality of the restoration is sufficiently acceptable but with 
minor shortcomings.  Because of their location/extent, however these cannot be eliminated 
without damage to the tooth, although no adverse effects are anticipated.  Scores 1 and 2 
would correspond to Ryge´s Alfa rating; Score 3 is equivalent to Bravo. 
 
If a parameter is judged to be unacceptable, a further distinction can be made 
between a clinically unsatisfactory and clinically poor result.  Scores 4 and 5 correspond to 
Ryge´s Charlie and Delta scoring, which means that a restoration scored 4 is unacceptable 
but repairable whereas a restoration scored 5 must be replaced [16]. 
 
In the event of a restoration being considered to be clinically unsatisfactory, this 
restoration will be excluded from the study and arrangements made to replace or, if 
appropriate, repair the defective or failed restoration.  The mode of failure of the restoration 
will be documented (Failed Restoration Form). 
 
The examiners assigned to review the restorations will have been trained in the 
evaluation system to be used, and will be capable of achieving at least 85% reproducibility in 
their assessments. 
 
The reviews will take place at one, two, three, and five years ± 1 month after placement. 
 
Adverse events or adverse device effects 
The Investigators are responsible for identifying adverse events, any untoward medical 
occurrence, that occurs to each subject throughout the study.  Adverse events must be 
documented on the (Serious) Adverse Event Form (Appendix 2).  Serious adverse events 
must be reported to the Sponsor within 24 h.  Study subjects who have experienced an 
adverse event may remain in the study as long as the safety, rights and /or welfare of subjects 

 
 
10 
are not put at risk and/or the restoration is unaffected concerning its quality and function.  
Serious adverse events are adverse events that (a) led to a death; (b) led to a serious 
deterioration in the health of the subject, or (c) led to fetal distress, fetal death or a 
congenital abnormality or birth defect.   
A device-related adverse event is one considered by the investigator to have a 
reasonable likelihood of being associated with the investigational device and is called an 
adverse device effect.  Adverse device effects must be documented on the Adverse Device 
Effect Form.  Serious adverse device effects must be reported within 24 h to the contact 
person at 3M ESPE, telephone number (651) 733-3384.  A serious adverse device 
effect is an effect that resulted in any of the consequences characteristic of a serious adverse 
event. 
 
(Near) Incident is any malfunction or deterioration in the characteristics and/or 
performance of a device, as well as any inadequacy in the labelling or instruction for use, 
which might lead or might have led to the death of a patient or user or to a serious 
deterioration in his state of health. 
 
Any incident that led to any hazard for the patient has to be regarded as adverse 
device effect and documented accordingly.  The Investigator reports serious (near) incidents 
as soon as possible and no later than 24 h to 3M ESPE.  
 
SUBJECT INCENTIVES 
All restorations carried out in this study will be at no cost to the subjects.  Subjects will be 
expected to attend the one-, two-, three-, and five-year follow up visits.  Compensation of 
$50 will be paid to each subject at baseline and each follow-up visit (total of $250). 
 
MONITORING 
The study will be monitored at appropriate intervals by Dr. Rolf H. Halvorson, Scientific 
Affairs Manager, 3M ESPE Dental Products, 3M Center, Bldg. 275-2SE-03, St. Paul, MN, 
55144 [rhhalvorson@mmm.com], or his designee, by means of regular contact to evaluate 
study data and photographs. 
 
DATABASE MANAGEMENT 
Each subject recruited into the study will be given a unique identifying code number and the 
subject’s identity will be kept confidential as far as is practical. 
 

 
 
11 
ANALYSIS OF THE RESULTS 
The demographic and baseline measurements, and the study data obtained, will be analyzed 
by means of tables of percentages to summarize the characteristics of the patients and the 
baseline data.  Tables of percentages will be prepared to illustrate the follow-up and 
retrospective analysis findings.  Cross tabulation will be prepared as necessary. 
 
Statistical analyses 
Chi-square (x2), McNemar and Mann-Whitney-U tests will be applied as appropriate to 
compare the baseline and follow-up/review findings regarding the two types of restorations. 
 
PROBLEM CASES  
In the case of an experimental Filtek™ Bulk Fill Posterior Restorative or Filtek™ Supreme 
Ultra Universal Restorative composite resin restoration being found to have failed or to be 
clinically unsatisfactory on review, the investigator will: 
• 
Complete the failed restoration form. 
• 
Make a photographic and silicone impression record of the failed restoration. 
• 
Make arrangements to replace or, if appropriate, repair the restoration. 
Replacements of failed restorations will not form part of the study. 
In the case of failure of restorations placed using either restorative system, the tooth will be 
re-restored at no cost to the subject or investigator.  The contact person at 3M ESPE (Rolf H. 
Halvorson, (651) 733-3384) should be notified before this treatment is done.  
 
ADVERSE EVENTS 
If an adverse event occurs any decision as to whether to prematurely stop the study will be 
taken jointly by the PI, 3M ESPE, and IRB.  Changes to the protocol will be by arrangement 
between the PI, IRB, and 3M ESPE, and will take the form of a signed amendment. 
In the event of an adverse reaction being shown to be related to the proposed use of 
any restorative material, any indemnity will be borne by 3M ESPE in accordance with the 
contract. 
 
REPORTS TO SPONSOR 
The PI will be responsible for the preparation and submission of the one-, two-, three-, and 
five-year reports to the Sponsor. 
 
PUBLICATION OF FINDINGS 
The investigators will be entitled to publish the study findings; the data also may be 
presented as an abstract or oral presentation at appropriate Dental Research meetings.  Any 

 
 
12 
manuscript, abstract or other form of presentation prepared for submission or public 
presentation will be submitted to the Sponsor for comment according to the contract.  The 
data will be communicated internally in 3M ESPE to appropriate members of the Business 
Team, Research and Development, Marketing, Regulatory and Professional Services 
personnel. 

 
 
13 
REFERENCES 
[1] 
Eick JD, Welch FH. Polymerization shrinkage of posterior composite resins and its 
possible influence on postoperative sensitivity. Quintessence Int 1986; 17:103-111. 
[2] 
Condon JR, Ferracane JL. Assessing the effect of composite formulation on 
polymerization stress. J Am Dent Assoc 2000; 131:497-503. 
[3] 
Bowen RL. Adhesive bonding of various materials to hard tooth tissues. VI. Forces 
developing in direct-filling materials during hardening. J Am Dent Assoc 1967; 
74:439-445. 
[4] 
Meredith N, Setchell DJ. In vitro measurement of cuspal strain and displacement in 
composite restored teeth. J Dent 1997; 25:331-337. 
[5] 
Versluis A, Tantbirojn D, Pintado MR, DeLong R, Douglas WH. Residual shrinkage 
stress distribution in molars after composite restoration. Dent Mater 2004; 20:554-
564. 
[6] 
Kemp-Scholte CM, Davidson CL. Marginal sealing of curing contraction gaps in Class 
V composite resin restorations. J Dent Res 1988; 67:841-845. 
 [7] 
Tolidis K, Nobecourt A, Randall RC. Effect of a resin-modified glass ionomer liner on 
volumetric polymerisation shrinkage of various composites. Dent Mater 1998; 
14:417-423. 
[8] 
Alomari QD, Reinhardt JW, Boyer DB. Effect of liners on cups deflection and gap 
formation in composite restorations. Oper Dent 2001; 26:406-411. 
[9] 
Davidson-Kaban SS, Davidson CL, Feilzer AJ, de Gee AJ, Erdilek N. The effect of 
curing light variations on bulk curing and wall-to-wall quality of two types and 
various shades of resin composites. Dent Mater 1997; 13:344-352. 
[10] 
Sakaguchi RL, Berge HX. Reduced light energy density decreases post-gel contraction 
while maintaining degree of conversion in composites. J Dent 1998; 26:695-700. 
[11] 
Kuijs RH, Fennis WMM, Kreulen CM, Barink M, Verdonschot N. Does layering 
minimize shrinkage stresses in composite restorations? J Dent Res 2003; 82:967-
971. 
[12] 
Deliperi S, Bardwell DN. An alternative method to reduce polymerization shrinkage 
in direct posterior composite restorations. J Am Dent Assoc 2002; 133:1387-1398. 
[13] 
Davidson CL, de Gee AJ, Feilzer A. The competition between the composite-dentin 
bond strength and the polymerization contraction stress. J Dent Res 1984; 63:1396-
1399. 
[14] 
Eick DJ, Robinson SJ, Byerley TJ, Chappelow CC. Adhesives and non shrinking 
dental resins of the future. Quintessence Int 1993; 24:632-640. 
[15] 
Davidson CL, Feilzer AJ. Polymerisation shrinkage and polymerisation shrinkage 
stress in polymer-based restoratives. J Dent 1997; 25:435-440. 

 
 
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[16] 
Hickel R, Roulet JF, Bayne S, Heintze SD, Mjör IA. Peters M, Roussons V, Randall R, 
Schmalz G, Tyas M Vanherle G. Recommendations for conducting controlled clinical 
studies of dental restorative materials. Clin Oral Invest 2007; 11:5-33. 
[17] 
Ryge G, Snyder M. Evaluating the clinical quality of restorations. J Am Dent Assoc 
1973; 87:369-377. 
[18] 
Leinfelder KF, Taylor DF, Barkmeier WW, Goldberg AJ. Quantitative wear 
measurement of posterior composite resins. Dent Mater 1986; 2:198-201. 

 
 
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Table 1.  FDI World Dental Federation criteria for evaluation of restorations. 
 
 
a) Aesthetic properties 
 
1. Surface luster 
2. Surface staining 
3. Color stability and 
translucency 
4. Anatomic form 
 
1. Clinically excellent / 
very good 
 
 
1.1. Luster comparable to 
enamel. 
 
 
2.1. No surface staining. 
 
 
3.1. Good color match, no 
difference in shade and 
translucency. 
 
 
4.1. Form is ideal. 
 
 
2. Clinically good 
(very good after polishing) 
 
 
1.2. Slightly dull, not noticeable 
from speaking distance. 
 
 
2.2. Minor surface staining, 
easily removable. 
 
 
3.2. Minor deviations. 
 
 
4.2. Form is only slightly 
affected. 
 
 
3. Clinically sufficient / 
satisfactory 
(minor shortcomings, no 
unacceptable effects but not 
adjustable without damage 
to the tooth) 
 
 
1.3. Dull surface but acceptable 
if covered with film of saliva. 
 
 
2.3. Moderate surface 
staining, also present on 
other teeth, not 
aesthetically unacceptable. 
 
 
3.3. Clear deviation but 
acceptable.  Does not affect 
aesthetics. 
3.3.1. More opaque. 
3.3.2. More translucent. 
3.3.3. Darker. 
3.3.4. Brighter. 
 
 
4.3. Form differs but is not 
aesthetically displeasing. 
 
 
4. Clinically 
unsatisfactory 
(but repairable) 
 
 
1.4. Rough surface, cannot be 
masked by saliva film, simple 
polishing is not sufficient.  
Further intervention necessary. 
 
 
 
2.4. Surface staining 
present on the restoration 
and is unacceptable.  Major 
intervention necessary for 
improvement. 
 
 
3.4. (Localized) clinically 
unsatisfactory but can be 
corrected by repair. 
3.4.1. Too opaque. 
3.4.2. Too translucent. 
3.4.3. Too dark. 
3.4.4. Too bright. 
 
 
4.4. Form is affected and 
unacceptable aesthetically.  
Intervention (correction) 
necessary. 
 
 
5. Clinically poor 
(replacement necessary) 
 
 
1.5. Quite rough, unacceptable 
plaque, retentive surface. 
 
 
2.5. Severe staining and / or 
subsurface staining 
(generalized or localized), 
not accessible for 
intervention. 
 
 
3.5. Unacceptable.  
Replacement necessary. 
 
 
4.5. Form is completely 
unsatisfactory and / or lost.  
Repair not feasible / 
reasonable, replacement 
needed. 

 
 
16
 
 
b) Functional 
properties 
 
 
5. Fractures and 
retention 
 
6. Marginal 
adaptation 
7. Wear 
 
8. Contact point 
/ food impact 
 
 
9. Radiographic 
examination (when 
applicable) 
 
10. Patient’s view 
 
 
1. Clinically 
excellent 
/ very good 
 
 
5.1. Restoration 
retained, no fractures 
/ cracks. 
 
 
6.1. Harmonious 
outline, no gaps, no 
discoloration. 
 
 
7.1. Physiological wear 
equivalent to enamel 
(80-120% of 
corresponding 
enamel). 
 
 
8.1. Normal contact 
point (floss or 25 
μm metal blade can 
be inserted but not 
50 μm blade). 
 
 
9.1. No pathology, 
harmonious transition 
between restoration and 
tooth. 
 
 
10.1. Entirely satisfied. 
 
 
2. Clinically good 
(very good after 
polishing) 
 
 
5.2. Small hairline 
crack. 
 
 
6.2.1. Marginal gap 
(50 μm). 
6.2.2. Small 
marginal fracture 
removable by 
polishing. 
 
 
7.2. Normal wear with 
only slight difference 
to enamel (50-80 % or 
120-150 % of 
corresponding 
enamel). 
 
 
8.2. Slightly too 
strong but no 
disadvantage. 
 
 
9.2.1. Acceptable excess 
present. 
9.2.2. Positive / negative 
step present at margin 
< 150 μm. 
 
 
10.2. Satisfied. 
 
 
3. Clinically 
sufficient 
/ satisfactory 
(minor 
shortcomings, 
no 
unacceptable 
effects but not 
adjustable 
without damage to 
the tooth) 
 
 
5.3. Two or more or 
larger hairline cracks 
and / or chipping 
(not affecting the 
marginal integrity or 
proximal contact). 
 
 
6.3.1. Gap < 150 μm 
not removable. 
6.3.2. Several small 
enamel or dentin 
fractures. 
 
 
7.3. Differing wear 
rate to enamel but 
within the biological 
variation (< 50 % or 
150-300 % of 
corresponding 
enamel). 
 
 
8.3. Slightly too 
weak, no indication 
of damage to tooth, 
gingiva or 
periodontal 
structures (50 μm 
metal blade can 
pass easily but not 
100 μm). 
 
 
9. 3. 1. Marginal gap < 
200 μm. 
9. 3. 2. Negative steps 
visible < 250 μm.  No 
adverse effects noticed. 
9.3.3. Poor radiopacity 
of filling material. 
 
 
10.3. Minor criticism of 
aesthetics. 
10.3.1. Aesthetic 
shortcomings. 
10.3.2. Some lack of 
chewing comfort. 
10.3.3. Time consuming 
procedure and / or 
similar. 
No adverse clinical 
effects. 
 
 
4. Clinically 
unsatisfactory 
(but repairable) 
 
 
5.4. Chipping that 
damage marginal 
quality or proximal 
contacts, bulk 
 
6.4.1. Gap > 250 μm 
or dentin / base 
exposed. 
 
7.4. Wear 
considerably exceeds 
normal enamel wear, 
or occlusal contact 
 
8.4. Too weak (100 
μm metal blade can 
pass) and possible 
damage (food 
 
9.4.1. Marginal gap > 
250 μm. 
9.4.2. Excess accessible 
but not removable. 
 
10.4. Desire for 
improvement 
(reshaping of anatomic 

 
 
17
fractures with or 
without partial loss 
(less than half of the 
restoration). 
 
6.4.2. Chipping 
damaging margins. 
6.4.3. Notable enamel 
or dentin wall 
fracture. 
 
points are lost 
(restoration > 300 % 
of enamel wear or 
antagonist > 300 %). 
 
impaction).  Repair 
possible. 
 
9.4.3. Negative steps > 
250 μm and repairable. 
 
form or refurbishing, 
etc.). 
 
 
 
 
 
 
5. Clinically poor 
(replacement 
necessary) 
 
 
5.5. (Partial or 
complete) loss of 
restoration. 
 
 
6.5. Filling is loose but 
in situ. 
 
 
7.5. Wear is excessive 
(restoration or 
antagonist > 500 % of 
corresponding 
enamel). 
 
 
8.5. Too weak and / 
or clear damage 
(food impaction) 
and / or pain / 
gingivitis.  Requires 
replacement. 
 
 
9.5.1. Secondary caries, 
large gaps. 
9.5.2. Apical pathology. 
9.5.3. Fracture / loss of 
restoration or tooth. 
 
 
10.5. Completely 
dissatisfied and / or 
adverse effects 
including pain. 
 
 
 
c) Biological 
properties 
 
11. Postoperative 
(hyper) sensitivity 
and tooth vitality 
 
12. Recurrence of 
caries, erosion, 
abfraction 
 
13. Tooth 
integrity 
(enamel cracks) 
 
 
14. Periodontal 
response (always 
compared to a 
reference tooth) 
 
15. Adjacent 
mucosa 
 
16. Oral and general 
health 
 
 
1. Clinically very 
good 
 
 
11.1. No 
hypersensitivity, normal 
vitality. 
 
 
12.1. No secondary or 
primary caries. 
 
 
13.1. Complete 
integrity. 
 
 
14.1. No plaque, no 
inflammation, no 
pockets. 
 
 
15.1. Healthy mucosa 
adjacent to 
restoration. 
 
 
16.1. No oral or general 
symptoms. 
 
 
2. Clinically good 
(after correction very 
good) 
 
 
11.2. Low 
hypersensitivity for a 
limited period of time, 
normal vitality. 
 
 
12.2. Very small and 
localized areas of: 
1. Demineralization, 2. 
Erosion, or  
3. Abfraction.   
No operative treatment 
required. 
 
 
13.2.1. Small 
marginal enamel 
split (< 150 μm). 
13.2.2. Hairline 
crack in enamel (< 
150 μm not 
probable). 
 
 
14.2. Little plaque, no 
inflammation 
(gingivitis), no pocket 
development. 
 
 
15.2. Healthy after 
minor removal of 
mechanical 
irritations (sharp 
edges, etc.). 
 
 
16.2. Minor transient 
symptoms of short 
duration (of known or 
unknown origin) local 
or generalized. 
 
 
 
 
12.3. Larger areas of: 
 
 
 
 

 
 
18
3. Clinically 
sufficient / 
satisfactory 
(minor shortcomings 
with no adverse 
effects but not 
adjustable without 
damage to the tooth) 
 
11.3.1. Premature / 
slightly more intense. 
11.3.2. Delayed 
/ weak sensitivity.  
No subjective 
complaints, no 
treatment needed. 
 
1. Demineralization, 
2. Erosion, or 
3. Abrasion / abfraction. 
Only preventive 
measures necessary 
(dentin not exposed). 
 
13.3.1. Enamel split 
< 250 μm. 
13.3.2. Crack < 250 
μm. 
No adverse effects. 
 
14.3.1. Plaque 
accumulation at 
acceptable level. 
14.3.2. Gingival 
bleeding acceptable. 
14.3.3. Pocket 
formation acceptable. 
 
15.3. Alteration of 
mucosa but no 
suspicion of causal 
relationship with 
filling material. 
 
16.3. Transient 
symptoms, local and / 
or general. 
 
 
 
 
4. Clinically 
unsatisfactory 
(repair for 
prophylactic reasons) 
 
 
11.4.1. Premature / very 
intense. 
11.4.2. Extremely 
delayed / weak with 
subjective complaints. 
11.4.3. Negative 
sensitivity. 
Intervention necessary 
but not replacement. 
 
 
12.4.1. Caries with 
cavitation. 
12.4.2. Erosion in dentin. 
12.4.3. Abrasion / 
abfraction in dentin. 
Localized and 
accessible and can 
be repaired. 
 
 
13.4.1. Major 
enamel split (gap > 
250 μm or dentin 
or base exposed). 
13.4.2. Crack > 250 
μm (probe 
penetrates). 
 
 
14.4.1. Plaque 
accumulation not 
acceptable. 
14.4.2. Gingival 
bleeding not 
acceptable. 
14.4.3. Pocket depth 
increase > 1 mm. 
 
 
15.4. Suspected mild 
allergic, lichenoid, or 
toxicological reaction. 
 
 
16.4. Persisting local or 
general symptoms of 
oral contact stomatitis, 
lichen planus, or 
allergic reactions (or 
remitting).  
Intervention necessary 
but no replacement. 
 
 
5. Clinically poor 
(replacement 
necessary) 
 
 
11.5. Very intense, acute 
pulpitis or non-vital.  
Endodontic treatment is 
necessary and 
restoration has to be 
replaced. 
 
 
12.5. Deep secondary 
caries or exposed dentin 
that is not accessible for 
repair of restoration. 
 
 
13.5. Cusp or tooth 
fracture. 
 
 
14.5. Severe / acute 
gingivitis or 
periodontitis. 
 
 
15.5. Suspected 
severe allergic, 
lichenoid, or 
toxicological reaction. 
 
 
16.5. Acute / severe 
local and / or general 
symptoms. 
 
 

 
 
19
APPENDIX 1 
 
Clinical investigation of a new bulk fill composite resin  
in the restoration of posterior teeth 
 
RANDOM NUMBERS TABLE 
 
30 
89 
 
34 
43 
 
98 
79 
 
50 
49 
98 
07 
 
53 
64 
 
54 
23 
 
87 
50 
91 
54 
 
58 
41 
 
06 
79 
 
69 
90 
13 
38 
 
59 
44 
 
46 
25 
 
38 
19 
65 
48 
 
27 
62 
 
58 
51 
 
79 
30 
78 
05 
 
73 
70 
 
42 
19 
 
74 
41 
75 
26 
 
79 
66 
 
12 
05 
 
88 
07 
15 
62 
 
76 
89 
 
23 
14 
 
38 
65 
63 
40 
 
79 
60 
 
02 
89 
 
31 
50 
10 
55 
 
17 
44 
 
07 
76 
 
62 
37 
05 
34 
 
19 
54 
 
27 
96 
 
52 
47 
27 
70 
 
88 
07 
 
10 
45 
 
77 
28 
71 
66 
 
24 
27 
 
16 
73 
 
03 
98 
43 
04 
 
83 
14 
 
13 
96 
 
53 
98 
65 
28 
 
89 
34 
 
06 
75 
 
17 
70 
51 
46 
 
21 
60 
 
13 
84 
 
32 
47 
06 
71 
 
33 
46 
 
59 
78 
 
29 
16 
21 
82 
 
98 
23 
 
75 
90 
 
10 
63 
69 
01 
 
90 
21 
 
57 
14 
 
98 
64 
92 
43 
 
88 
01 
 
29 
12 
 
45 
58 
16 
81 
 
70 
31 
 
43 
02 
 
93 
10 
35 
12 
 
65 
24 
 
50 
71 
 
43 
04 
72 
79 
 
96 
25 
 
39 
14 
 
21 
88 
20 
31 
 
03 
98 
 
60 
51 
 
93 
62 
89 
68 
 
51 
28 
 
99 
30 
 
67 
48 
46 
81 
 
92 
79 
 
93 
02 
 
71 
26 
19 
98 
 
34 
59 
 
48 
29 
 
03 
22 
46 
93 
 
59 
42 
 
41 
42 
 
13 
74 
07 
30 
 
41 
50 
 
11 
80 
 
23 
78 
06 
22 
 
74 
23 
 
59 
70 
 
18 
05 
36 
97 
 
60 
89 
 
07 
24 
 
48 
17 
06 
31 
 
70 
27 
 
37 
18 
 
53 
94 
05 
08 
 
53 
09 
 
70 
88 
 
63 
02 
20 
82 
 
16 
77 
 
29 
58 
 
37 
50 
17 
60 
 
07 
20 
 
21 
10 
 
90 
13 
94 
09 
 
87 
30 
 
12 
53 
 
62 
91 
31 
26 
 
50 
29 
 
52 
19 
 
41 
98 
70 
07 
 
17 
36 
 
92 
21 
 
14 
29 
81 
18 
 
51 
12 
 
67 
04 
 
21 
72 
03 
44 
 
27 
40 
 
58 
17 
 
32 
01 
29 
78 
 
41 
60 
 
37 
88 
 
51 
02 

 
 
APPENDIX 2 
 
Clinical investigation of a new bulk fill composite resin  
in the restoration of posterior teeth 
 
ADVERSE EVENT REPORT FORM 
 
Subject #: _______________ 
Date:           /         /          . 
Examiner: ___________________ 
Tooth #: _______ 
Number of surfaces:  ☐ 2        ☐ 3        ☐ 4        Specify: ☐ M        ☐ D        ☐ O        ☐ F        ☐ L 
Material: 
☐ 3M ESPE Filtek™ Bulk Fill Posterior Restorative 
 
 
☐ 3M ESPE Filtek™ Supreme Ultra Universal Restorative 
Radiograph(s) taken: ☐ Yes     ☐ No 
 
Photographs taken: ☐ Yes     ☐ No 
 
Describe the Adverse Device Effect; provide chronology of events, actions taken and outcome.   
Use another form if needed. 
 
 
 
 
 
 
 
 
 
 
 
 
 
Did the adverse device effect increase in severity?  ☐ Yes     ☐ No 
If yes, to what degree?  ☐ Moderate     ☐ Severe 
 
Document the provision made for subjects in the event of injury arising from participation in 
the study:  
 
Signature of clinician:  
 
 
 
 
Date:          /         /          . 
Fax completed form within five days of incidence of Adverse Event to study monitor 
Rolf H. Halvorson at (651) 733-3384. 
 
 
 

 
 
APPENDIX 3 
 
 
AGREEMENT TO PROTOCOL 
 
 
 
 
 
 
 
 
 
____________________________ 
____________________________ 
 
Dr. Ricardo Walter 
Dr. Andreas Syrek 
Principal Investigator 
Scientific Affairs Manager 
UNC School of Dentistry 
3M ESPE Europe 
 
Date  ________________ 
Date  ________________