Clinical Evaluation of Kerr SonicFill™ 2 vs 3M ESPE Filtek™ Supreme Ultra Universal Restorative
Phase: NA
Conditions: Dental Caries
Sponsor: Tufts University

Confidential 
 
 
 
 
 
 
 
 
Clinical Evaluation of Kerr SonicFill™ 2 vs 3M ESPE Filtek™ 
Supreme Ultra Universal Restorative  
___________________________________________________________ 
 
 
 
Principal Investigator:   
Gerard Kugel, DMD, MS, PhD  
 
 
Co-Investigators: 
 
Mabi Singh, DMD, MS 
 
 
 
 
 
Britta Magnuson, DMD 
 
 
 
 
 
Yoon H. Kang, DMD, PhD 
 
 
 
 
 
Matthew Finkelman, PhD 
 
 
 
 
 
Duong Tran, DDS, MPH, PhD 
 
 
 
 
 
Ronald Perry, DMD, MS 
 
 
 
 
Study Location:  
 
Tufts University School of Dental Medicine 
One Kneeland Street  
Boston, MA 02111 
 
Sponsor:       
 
 
Kavo Kerr Group      
    
 
 
 
Protocol Version Date:   
11/2/2018 
 
 

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I) Introduction 
A) Aim/Hypothesis/Objective 
The primary objective of this study is to evaluate the clinical performance of a 
sonic-activated, bulk fill composite, SonicFill™ 2, by comparing it to Filtek™ 
Supreme Ultra in the following categories1:  
Esthetic Properties 
• 
Surface luster 
• 
Staining – surface  
• 
Staining – margin 
• 
Color match and translucency 
• 
Esthetic anatomical form 
 
Functional Properties 
• 
Fracture of material and retention 
• 
Marginal adaptation 
• 
Aproximal anatomical form – contact point 
• 
Radiographic examination (when applicable) 
• 
Patient’s view 
Biological Properties 
• Postoperative (hyper-)sensitivity and tooth vitality 
• Recurrence of caries, erosion, abfraction 
• Tooth integrity (enamel cracks, tooth fractures) 
• Adjacent mucosa 
 
The hypothesis to be tested is that the sonic-activated, bulk fill composite, 
SonicFill™ 2, will have comparable results to the traditional incremental 
technique composite, Filtek™ Supreme Ultra, in overall clinical acceptability 
and in all compared categories 
 
II) Background and Rationale 
Marginal leakage appears to be an inherent shortcoming of all dental restorations. 
2-6 Various techniques have been advocated to enhance the marginal adaptation 
and reduce the microleakage of composite restorations. Multilayer techniques, in 
contrast to bulk packing methods, have decreased marginal gap formations. 7,8The 
size reduction of the composite material, the diminution of polymerization 
shrinkage, and the enlargement of the free surface area in relation to the volume 
are of great importance in this context. 9 When the whole margin area is first filled 
with an increment, fewer contraction gaps at the margins can be expected.  
Traditional, incrementally filled dental composite material has been on the market 
for many years, and has been proven successful for use in posterior restorations.  
Traditional composite techniques require small amounts (up to 2mm) of composite 
be placed at a time and then light cured.  This process is pain staking and time 
consuming.  Newer products on the market are bulk fill – allowing increments of 
up to 5mm to be placed before light curing.  Many of these products then require 
a capping material to be placed over them.  The newer SonicFill™ 2 system is a 

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sonic-activated, bulk fill composite that allows placement of material up to 5mm 
without the need for a capping layer.10 The sonic activated technique allows for 
easy placement and good adaptation of the restoration. This process also shortens 
the time necessary to complete a restoration, which benefits both the dental 
practitioner and the dental patient. 
 
Standard of Care at TUSDM clinics 
The standard of care in the TUSDM clinics is to place composite following the 
incremental technique with Filtek™ Supreme Ultra (the resin composite used as a 
control in this study). 
 
III) Research Plan 
A) Experimental Design 
This study is a randomized, split-mouth, controlled, examiner-blinded clinical 
evaluation of Class II restorations using a new bulk-fill composite (SonicFill™ 
2) and comparing it to 3M ESPE Filtek™ Supreme Ultra resin composite placed 
in the traditional incremental technique. 
 
B) Sample Size and Statistical Analysis 
Sample size  
A sample size calculation was conducted using nQuery Advisor (version 7.0).  
The calculation determined that with a sample size of n=35 subjects, all 95% 
confidence intervals will have a margin of error of no more than 16.6%. Up to 
44 subjects will be treated to allow for 20% dropout. Up to 100 will be screened 
to have 35 qualifying subjects complete the study. 
 
Statistical analysis 
Tables of descriptive statistics (counts and percentages for categorical 
variables, means and standard deviations for continuous variables) will be 
prepared to summarize the demographic characteristics of the patients, the 
distribution of restorations and baseline data, and to illustrate the recall and 
data analysis findings.  Because the hypothesis of the study does not involve 
superiority of one technique over another, and comparable results between 
SonicFill™ 2 and Filtek™ Supreme Ultra are anticipated, confidence intervals 
will be used rather than p-values.  In particular, for each evaluation category, 
the percentage of times that SonicFill™ 2 outperforms Filtek™ Supreme Ultra, 
the percentage of times that Filtek™ Supreme Ultra outperform SonicFill™ 2, 
and the percentage of times with equal performance will be calculated along 
with 95% confidence intervals.  Frequency distributions will also be calculated 
for each combination of technique and evaluation category, along with 95% 
confidence intervals.  SPSS (Version 22) and R (Version 3.1.2) will be used in 
the analysis. 
 
Randomization 
A computerized randomization scheme will be developed to randomize which 
teeth will be in the study and which group each tooth will be in.  The “sample 
function” in R version 3.1.2 will be used. Assignment of study teeth and 
treatment allocation will be recorded in each subject’s Case Report Form (CRF). 

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Blinding  
The restoration grading investigator and the subject will be blinded as to which 
group each restoration is in.  
 
C) Products 
All study materials – SonicFill™ 2, SonicFill™ 2 Handpiece and coupler, 
Optibond XRT, Scotchbond™ Universal and Filtek™ Supreme Ultra resin 
composite will be provided by Kavo Kerr Group and have received 510(k) 
clearance from the United States Food and Drug Administration (FDA) as Class 
II non-significant risk medical devices.  All products will be used according to 
their FDA clearance in this study. 
  
Group            Resin Composite 
Bonding Agent 
1 
SonicFill™ 2 
Optibond XRT 
2 
Filtek™ Supreme Ultra  
Scotchbond™ 
Universal 
Adhesive 
 
Receipt and usage of the clinical study supplies and products will be 
documented in the study file.  The study materials will be stored in a locked 
closet/cabinet and will be accessible only to the research team members.  
Products may be stored at room temperature. The sponsor may request that 
some supplies be returned at the end of the study. 
 
Restriction in Device Use 
The Principal Investigator is responsible for limiting access of the device to 
participants in this trial and ensuring it is used only as specified in the protocol. 
The device shall be stored as specified by the sponsor. 
 
SonicFill™ 211 
SonicFill™ 2 is, a sonic-activated, bulk fill dental composite system for 
posterior restorations that requires no additional capping layer. Proprietary 
sonic activation enables a rapid flow of composite into the cavity for placement 
and adaptation.  
 
OptiBond XTR12 
OptiBond XTR self-etch, light-cure universal dental adhesive Universal 
compatibility enables use for all direct and indirect restorations. The self-etch 
primer and adhesive in this 2-bottle system brings increased bond strengths 
to uncut enamel and dentin. OptiBond XTR uses GPDM (glycerophosphoric acid 
dimethacrylate, an phosphate based adhesive monomer) technology, ternary 
solvent system, filled adhesive and optimized formulation to produce adhesion 
for direct and indirect procedures.  
 
Filtek™ Supreme Ultra Universal Restorative13 Filtek™ Supreme Ultra is a 
Universal Nanocomposite dental restorative material that is visible-light 

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activated, designed for use in anterior and posterior restorations of any class.  
This restorative material is available in a wide variety of Dentin, Enamel, Body, 
Translucent shades, and all shades are radiopaque.  Filtek™ Supreme Ultra 
uses nanofiller technology to give restorations polish retention.   
 
 
Scotchbond™ Universal Adhesive14 
Scotchbond™ Universal is a single-bottle adhesive solution for all surfaces, and 
can be used in total-etch, self-etch or selective-etch mode for both direct and 
indirect restorations. Scotchbond™ Universal provides consistent bond 
strength to both moist and dry etched dentin, without additional primer.  
 
D) Subject Characteristics 
1) Inclusion Criteria 
To be considered eligible for this study, each patient must meet all criteria 
listed below: 
- 
Is at least 18 years of age 
- 
Is willing to provide voluntary written informed consent 
- 
Is in good medical health and able to tolerate the dental procedures 
- 
Has 1 pair of qualifying molars or premolars that require Class II 
restorations.  Patients with more than 2 cavities may be enrolled but the 
additional teeth will not be included in the study. 
- 
Restorations must have a buccal to lingual/palatal width equal to or 
greater than 1/3 the distance from buccal to lingual/palatal cusp tips 
- 
Study teeth must be in occlusal function and must also be in contact 
with the neighboring tooth on at least one surface 
- 
Study teeth must be vital (i.e., free of clinical signs and symptoms of 
periapical pathology) 
2) Exclusion Criteria 
Subjects will be considered ineligible for the study if they meet any criterion 
listed below: 
- 
Is currently taking part in an evaluation of other dental restorative 
materials 
- 
Has chronic periodontitis or rampant caries 
- 
Teeth exhibiting clinical signs of periapical pathology 
- 
Teeth with a history of self-reported preoperative pulpal problems 
- 
Women who are pregnant (self-reported). It is standard of care to post-
pone routine dental procedures and radiographed until after pregnancy. 
- 
Women who are breast feeding. 
- 
Known allergy to resin composites or local anesthetics. 
- 
An employee of the sponsor or members of their immediate family. 
- 
Condition affecting salivary flow (e.g., salivary gland disorder, 
Sjögren’s Syndrome)  
- 
Any restorative treatment of the teeth involved in the study in the last 
12 months. 
- 
Are unwilling or unable to have dental radiographs or photographs taken 
of their dentition and soft tissues 

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- 
Any other condition which is the view of the investigator may affect the 
ability of a patient to complete the study. 
 
3) Subject Withdrawal/Termination Criteria 
− Subjects who do not comply with the study procedures, such as 
returning for follow up visits may be withdrawn from the study. 
− Subjects who decide to stop participating in the study will be withdrawn. 
− Subjects who have a clinical pulp exposure during restoration visit will 
be withdrawn from study and standard of care procedures for pulp 
exposure and restoration placement will be followed and patient will be 
advised if they need further treatment and should be seen by a dentist 
outside the study (such as root canal therapy and/or crown).  
− Subjects who have external procedures or treatments performed on 
study teeth will be withdrawn from the study. However, if external 
treatment is only performed on one study tooth, the subject can still 
participate in the study and the remaining, unaffected study tooth will 
still be monitored for research purposes. 
− Unanticipated Adverse Device Effect  
 
The Principal Investigator will determine whether subjects (either 
withdrawn subjects or subjects completing the study) are in need of 
additional treatment and/or follow-up observation as a result of 
participation in this trial (such as if a restoration fails). Additional 
treatment may be needed for teeth that are not included in this study, 
but require a restoration. Subjects and/or their insurance will be 
responsible for the cost of any standard of care follow-up visits or 
additional treatment that is not part of this study. 
 
 
E) Assessment 
1) Risk 
The patient may expect the usual post-operative pain or sensitivity that is 
typically associated with the standard of care placement of dental 
restorations, (the risks for both groups is anticipated to be the same and 
are not greater than standard of care risks), including: tooth pain, bite 
pain/sensitivity, gingival sensitivity/tenderness/redness, discomfort from 
the anesthetic, or allergic reaction to the anesthetic.  These events are 
expected to be localized and transient in nature.   
Another potential risk is partial loss, chipping, or fracture of the restoration, 
trauma to restored or adjacent teeth, or total loss of the restoration.  
However, the rate of occurrence is anticipated to be very low (no higher 
than for other restorations).   
The risk of radiographs will be kept to a minimum using standard of care 
procedures (lead apron, digital radiographs, etc.). It is standard of care to 
have bitewing radiographs annually for caries detection. It is standard of 
care to have periapical radiographs prior to class II restorations to ensure 
there are no signs of periapical pathology. These risks are not beyond 

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standard of care risks. At radiograph time, all female subjects will be 
questioned regarding pregnancy. Any responding positively at the time of 
screening will be excluded in accordance with the inclusion/exclusion 
criteria. If a subject becomes pregnant during the course of the study, 
radiographs will be delayed until after delivery. 
 
There is the risk of loss of confidentiality to the subject by participating in 
this study.  This risk will be kept to a minimum by following procedures 
listed under confidentiality section. 
 
2) Benefits 
There is no direct medical benefit to the subject for participation in this 
study.  
 
3) Alternatives 
Patients may choose not to participate in the study. A patient may choose 
to have the procedure completed at the TUSDM or their private dentist at 
normal clinic fees. 
 
F) Study Procedures 
 
Visit 1 (Approximately 1 hour): Screening 
The subjects will be instructed to read the informed consent form (ICF). 
Subjects will be given ample time to have any questions answered. If a subject 
decides to participate, he or she will be instructed to sign the ICF. A copy of 
the ICF will be given to the subject. 
 
Subject will be asked to complete demographic information and a medical 
history. 
 
An oral exam, including evaluation of oral cavity, soft and hard tissues, will be 
completed following standard of care procedures in US dentistry using a mouth 
mirror and dental explorer. 
 
Radiographs (bitewings) will be taken if none exist that are less than 1 year 
old and of diagnostic quality. It is within standard of care to take radiographs 
for caries detection if none less than 1 year old exist. 
 
Inclusion/exclusion criteria will be evaluated. 
 
If you are eligible to continue in the study, randomization will occur. 
 
Periapical radiographs will be taken on the randomized teeth (if none exist that 
are less than 1 year old and of diagnostic quality). It is standard of care to 
have periapical radiographs prior to class II restorations to ensure there are 
no signs of periapical pathology. 
 
 

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Visit 2 (May occur same day as Visit 1 and up to 1 month after Visit 1)(1.5-2 
hours):Restoration Placement 
 
Medical history will be reviewed and any changes will be noted.  
 
Eligibility and subject withdrawal criteria will be reviewed to ensure the subject 
still qualifies for the study.  
 
Oral exam will occur as at Visit 1. 
 
 
Intraoral photographs will be taken (photographs will only be intraoral, no 
facial photographs will be taken). 
 
Sensitivity will be assessed on randomized teeth. Subjects will be asked if they 
experience any sensitivity on the randomized teeth. If yes, they will be asked 
to rate their sensitivity on a scale of 1-100. 
 
Group 1: SonicFill™ 2 Restoration 
Local anesthesia will be achieved following standard of care. 
Composite shade will be chosen. 
Rubber dam or other appropriate isolation will be placed following standard of 
care. 
Tooth will be prepared for restoration following standard of care (using 
handpieces, burs, hand instruments, etc. as needed).  All decay will be 
removed. 
Etching and bonding will be achieved using Optibond XRT following 
manufacturer’s instructions. 
Restoration will be placed and cured using SonicFill 2 following manufacturer’s 
instructions. 
Finishing and polishing steps will be completed using Axis ProGloss Polishing 
System. 
 
Group 2: Filtek™ Supreme Ultra: 
Local anesthesia will be achieved following standard of care. 
Composite shade will be chosen. 
Rubber dam or other appropriate isolation will be placed following standard of 
care. 
Tooth will be prepared for restoration following standard of care (using 
handpieces, burs, hand instruments, etc. as needed).  All decay will be 
removed. 
Etching and bonding will be achieved using Scotchbond Universal following 
manufacturer’s instructions. 
Restoration will be placed and cured using Filtek™ Supreme Ultra following 
manufacturer’s instructions. 

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Finishing and polishing steps will be completed using Axis ProGloss Polishing 
System. 
 
Intraoral photographs will be taken. 
 
Restorations will be evaluated by the grading investigator (an investigator 
other than who placed the restorations) according to Hickel criteria (Appendix 
A).1 
 
 
Visit 3 (6 months +/- 1 month after Visit 2) (Approximately 30 mins): Follow-
Up 
 
Medical history will be reviewed and any changes will be noted.  
 
Eligibility and subject withdrawal criteria will be reviewed to ensure the subject 
still qualifies for the study.  
 
Oral exam will occur as at Visit 1. 
 
Restorations will be evaluated by the grading investigator (an investigator 
other than who placed the restorations) according to Hickel criteria.1 
 
Intraoral photographs will be taken. 
 
 
Visit 4 (1 year +/- 1 month after Visit 2) (Approximately 45 mins): Follow Up 
 
Medical history will be reviewed and any changes will be noted.  
 
Eligibility and subject withdrawal criteria will be reviewed to ensure the subject 
still qualifies for the study.  
 
Oral exam will occur as at Visit 1. 
 
Radiographs (periapical radiographs) will be taken.  It is within standard of 
care to take radiographs yearly after restoration placement. 
 
Restorations will be evaluated by the grading investigator (an investigator 
other than who placed the restorations) according to Hickel criteria.1 
 
Intraoral photographs will be taken. 
 
Visit 5 (2 years +/- 2 months after Visit 2) (Approximately 1 hour): Follow Up 
 
A new medical history form will be completed by the subject.  
 

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Eligibility and subject withdrawal criteria will be reviewed to ensure the subject 
still qualifies for the study.  
 
Oral exam will occur as at Visit 1. 
 
Radiographs (periapical radiographs) will be taken.  It is within standard of 
care to take radiographs yearly after restoration placement. 
 
Restorations will be evaluated by the grading investigator (an investigator 
other than who placed the restorations) according to Hickel criteria.1 
 
Intraoral photographs will be taken. 
 
 
Radiographs 
 
All radiographs will be taken digitally following standard of care procedures, 
including the subject wearing a lead apron. The radiographs used in this study 
contain no more radiation than would be used in a customary dental procedure. 
It is within standard of care to take radiographs for caries screening if 
radiographs that are of diagnostic quality from within the past 1 year do not 
exist.  It is within standard of care to take radiographs yearly for evaluation 
after restoration placement. Radiographs will be taken at the one-year and two 
year recalls. In the event an adverse event is suspected, it is clinically 
necessary, or due to a dental emergency a radiograph may be taken at the 
time of the AE or emergency, but it is not the norm for this trial.  
 
At radiograph time, all female subjects will be questioned regarding pregnancy. 
Any responding positively at the time of screening will be excluded in 
accordance with the inclusion/exclusion criteria. If a subject becomes pregnant 
during the course of the study, radiographs will be delayed until after delivery. 
Subjects unwilling or unable to have dental radiographs will be excluded from 
the study.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Table 1. Subject Timeline 
 
 
                        Appointment 
 
 
Procedures 
Visit 1 
Screening 
Visit 2 
Baseline 
Visit 3 
6 month 
 
Visit 4 
1 year 
 
Visit 5 
2 year 
Informed Consent Form 
X 
 
 
 
 
Demographics 
X 
 
 
 
 
Medical History 
X 
X 
X 
X 
X 
Evaluate eligibility and 
withdrawal criteria 
X 
X 
X 
X 
X 
Oral Mucosal Tissue 
Examination 
X 
X 
X 
X 
X 
Radiographs 
If needed 
 
 
X 
X 
Randomization 
X 
 
 
 
 
Intraoral Photographs 
 
X 
X 
X 
X 
Sensitivity Assessment 
 
X 
 
 
 
Restoration Placement 
 
X 
 
 
 
Hickel Criteria Grading 
 
X 
X 
X 
X 
Adverse Event Assessment 
 
X 
X 
X 
X 
Stipend 
X 
X 
X 
X 
X 
 
 
G) Subject Safety  
1) Adverse Event Reporting 
 
Any adverse reactions to the treatment provided as part of the study will 
be fully investigated and recorded, including details of the appropriate 
clinical action taken, and reported to both the IRB and contact person at 
Kerr Corporation. 
 
Adverse Events 
An adverse event is any untoward or unfavorable medical occurrence in a 
human subject, including any abnormal physical exam or laboratory 
finding, symptom, or disease, temporally associated with a subject’s 
participation in the research.  
 
Adverse events will be recorded in source documents and on case report 
forms. All adverse events and non-serious situations will be recorded, 
monitored, and reported to the IRB at time of continuing review or at the 
study’s termination if this occurs before the study’s next continuing review.  
 
Serious Adverse Events  
A serious adverse event is one that results in death, or is life-threatening, 
or results in hospitalization or prolongation of existing hospitalization, or 
results in a persistent or significant disability/incapacitation, or results in a 

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congenital anomaly/birth defect, or may jeopardize the subject’s health and 
may require medical or surgical intervention to prevent one of the other 
outcomes listed above. 
 
Serious adverse events will be recorded in source documents and on case 
report forms. Serious Adverse Events that meet the criteria of an 
unanticipated problem will be reported to the IRB within 5 business days 
following the Reportable New Information Policy. Serious Adverse Events 
not meeting the criteria for an unanticipated problem will be reported to 
the IRB at time of continuing review or at the study’s termination if this 
occurs before the study’s next continuing review. 
 
Unanticipated Problems 
An unanticipated problem is an incident, experience, or outcome that meets 
all of the following criteria: 1) The nature, severity, or frequency is 
unexpected for the subject population or research activities as described in 
the current IRB approved protocol, supporting documents, and the ICF(s); 
2) it is related or possibly related to participation in the research; 3) it 
suggests the research may place the subject or others at a greater risk of 
harm then was previously recognized. 
 
Unanticipated problems will be recorded in source documents and on case 
report forms. Unanticipated problems will be reported to the IRB within 5 
business days after the PI/study team becomes aware of the problem. A 
Reportable New Information Form will be submitted to the IRB no later than 
5 business days after the PI/study team becomes aware of the problem. 
 
Unanticipated Adverse Device Effects (UADEs)  
Unanticipated adverse device effect means any serious adverse effect on 
health or safety or any life-threatening problem or death caused by, or 
associated with, a device, if that effect, problem, or death was not 
previously identified in nature, severity, or degree of incidence in the 
investigational plan or application (including a supplementary plan or 
application), or any other unanticipated serious problem associated with a 
device that relates to the rights, safety, or welfare of subjects.  
 
UADEs will be documented in source documents and on case report forms 
as to onset, severity, duration, management, outcome and relatedness to 
the test device. UADEs will be reported to the IRB within 5 business days 
after learning of the effect. 
 
H) Ethical Standards 
1) Institutional Review Board (IRB) approval will be obtained prior to 
commencing the study. The Principal Investigator will ensure that this study 
is conducted in full conformance with the US Federal laws and regulations, 
as well as the ICH’s Good Clinical Practice Guidelines.15 
 
I) Subject Participation 

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1) Screening 
The PI or Co-Is will conduct screening examinations to identify subjects 
who meet the inclusion / exclusion criteria for enrollment into the study. 
 
2) Informed Consent 
Dr. Kugel and/or his representative will introduce the study.   
 
Consenting will take place in a private clinic bay area and the patient will 
be given as much time as he/she needs to consider participation. The 
participant will be invited to include or exclude any associates (e.g., loved 
ones) in the consent process.  
 
Patients will be asked to read the consent form and given ample opportunity 
to have their questions answered.  To avoid coercion, the consenting 
investigator will read through the copy of the consent form with the 
participant section by section, making sure the participant understands 
each section and has an opportunity to ask questions.  If at any time the 
participant indicates s/he is not interested in participation, the meeting will 
end.   
 
If after going through the consent form, the participant indicates s/he would 
like to discuss the study with associates or think about participating, then 
the meeting will be ended and the participant will be asked to contact the 
study when s/he makes her decision. If the participant contacts the study 
in the future for participation, s/he will be invited back to the clinic, and if 
informed consent is given at that time, study activities will begin then. 
 
If the participant indicates s/he may be interested in participating after 
going through the consent form with the investigator, and the investigator 
determines the participant has the capacity to provide informed consent, 
the participant will be asked to provide informed consent at that time. 
Patients will certify their willingness to participate in the study by signing 
and dating the IRB approved informed consent document.  The subject will 
be given a copy of the consent form.    
 
If any new finding requires any change to the informed consent form, the 
subject will be re-consented. 
 
Non-English speaking subjects will not be enrolled in the study because 
study staff at this time are not certified, prepared, or trained to translate 
or communicate in any language other than English. The study budget does 
not allow for the payment of translation services at this time. There are no 
direct benefits to this population by participating in this study. 
 
3) Study Location 
Tufts University School of Dental Medicine 
 

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4) Personnel 
Ongoing communication with the IRB and sponsor – The PI 
Obtaining consent – The PI or his representative 
Conducting screenings – The PI or Co-Is 
Placement of restorations – The PI or Co-Is 
Evaluation of restorations – The PI or Co-Is (who did not place 
restoration) 
Maintaining paperwork – The PI and/or study coordinator 
 
 
 
 
5)  Anticipated Study Timeline* 
- 
Protocol and ICF Submission to the IRB: September 2016 
-   Approval by the IRB: October 2016 
- 
Subject Recruitment, Screening, Enrollment and Randomization:  
 
June 2017-December 2017  
- 
Placement of Restorations- June 2017-January 2018  
- 
Initial Report- January 2018-February 2018  
- 
Six Months Follow up- December 2017- June 2018 
- 
Six Months Report- July 2018-August 2018 
- 
One year follow up- June 2018-December 2018 
- 
One year Report- January 2019- February 2019 
- 
Two year follow up- June 2019-December 2019 
- 
Final Clinical Study Report- December 2019- January 2020 
 
*this timeline is subject to change depending on completion of study enrollment 
 
 
6) Payment for Participation 
(a) Compensation 
Restorations will be provided free of charge.  A total stipend of up to 
$245 in gift-card form will be awarded per subject in the manner as 
follows: $25 at screening; $50 at baseline; $50 at six month recall; $50 
at one year; and $70 at two years. Gift cards to Target will be given. 
The subject will not receive compensation for any missed recall 
appointments. Subjects will be responsible for paying all procedural 
costs not study related, as well as costs incurred after the study expires.  
 
(b) Transportation 
No travel reimbursement or transportation costs will be paid. Expenses, 
such as parking and transportation costs, will be paid by the subject at 
all times. 
 
(c) Payment and Insurance 
Neither the subject, nor their insurance company, will be billed for any 
study procedures. 
 

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(d) Provision for Care in Case of Accident or Injury 
In the unlikely event that a study patient becomes ill or is injured as a 
result of participating in this study and medical care is necessary, such 
medical care will be provided by a physician chosen by the patient. In 
the event of a research-related injury, compensation will be determined 
on a case-by-case basis by KaVo Kerr Group and Tufts University. 
 
7) Study Results 
If interested, study results will be presented to a subject upon their 
request, either in person or via mail according to their preference, upon 
completion of the study. A log will be kept of the participants who are 
interested in receiving study results. 
 
8) Confidentiality 
To ensure confidentiality of subject information, each subject enrolled in 
the study will be assigned a unique alphanumeric code. Subjects’ files and 
all study paperwork will be kept in a secure, locked cabinet in a secure room 
when the documentation is not being reviewed. The information will only 
be shared between the researchers. Source documents and case report 
forms will be coded and free of subject names. Photographs will be taken 
of subject’s teeth only (no facials). All HIPAA requirements will be followed. 
All electronic files will be kept on a password protected computer in a 
secure, locked office. 
 
(a) Coding 
Each will be assigned a subject identification number.  Alphanumeric 
identification numbers will be assigned sequentially. The full subject 
identification number will consist of the three letters from the subject’s 
initials and their enrollment number.  This will be accessible by study 
personnel only. 
 
(b) Access 
Only study personnel will have access to data.  Investigators will permit 
monitoring, audits, and regulatory inspections and will provide direct 
access to study related documentation. 
 
9) Data Safety Monitoring Plan: 
The study will be monitored at appropriate intervals by a trained member 
of the Kavo Kerr R&D clinical Research group (or qualified designee) by 
means of visits to the study clinic to evaluate patient charts, study data, 
and study photographs. Study monitoring visits will involve review of the 
study status and any issues related to the study. All Informed Consent 
forms will be reviewed for signatures and dates. Patient charts/records will 
be reviewed to ensure that all enrolled subjects meet the study inclusion 
and exclusion criteria. All CRFs will be reviewed for completeness of data 
entry to ensure that the study protocol is being followed, and to perform 
source data verification against information contained in the patient charts. 

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Materials will be checked for adequate storage and sufficient quantity to 
meet the study needs. 
 
Study personnel will monitor this trial for all safety related issues to 
determine whether an unreasonable risk to subjects develops. Quality 
control measures include routine inspection of case report forms, source 
documents, data tabulations, and tracking of adverse events. 
 
Complaints  
Complaint means any written, electronic or oral communication that alleges 
deficiencies related to the identity, quality, durability, reliability, safety, 
effectiveness, or performance of a device. Complaints will be reported in 
source documents and on case report forms. 
 
 
10) New Findings 
The subject will be informed of any significant new findings discovered 
during the course of this study that might influence the subject’s 
continuation and participation in the study.  Subjects will be told at a study 
appointment or via telephone of new findings during the study.   
 
Cost of treatment for any new findings will not be covered by the study. 
 
If new findings require revisions to the ICF, the subject will be re-
consented. 
 
11) Policy Regarding Replacement of Restorations 
 
All subjects will be pre-screened by the two examiners.  Participants will be 
advised of any dental pathology diagnosed (periapical lesions, caries, 
periodontal problems, etc) at that time and advised of the specific 
treatment(s) needed (root canal treatment, restoration, core build-up, 
periodontal therapy, etc).  If any pathology is found, each individual must 
arrange to have the pathology treated at their own expense.  A second 
examination will be scheduled to assess that treatment before these 
candidates are considered for inclusion in this study.  
 
If conditions arise in which the subject requires endodontic treatment after 
the restoration is placed and is within the study duration (two years), the 
subject will be responsible for any root canal and/or post and core 
treatment.  However, Kavo Ker Group will reimburse the School of Dental 
Medicine for the cost of the restoration (up to $175 per unit depending on 
the type of the restoration) which will be credited to the subject towards 
the cost of his/her new restoration.   In order to receive this level of 

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support, study participants must attend all initial appointments and all 
recall appointments for the duration of the study, otherwise this policy is 
voided. 
 
Before any re-treatment is initiated, a second dentist not associated with 
the study, will be selected by the Investigator in consultation with Kavo 
Kerr Group.  That individual will evaluate the cause of failure and determine 
the need for a new restoration.  The study sponsor or the School of Dental 
Medicine at Tufts University will not be held responsible for any re-
treatment when trauma or injury are determined to be the cause of failure 
and said failure is unrelated to participation in the study.    
 
I) Record Retention 
1) Study Records 
The Investigator will maintain all study records and documents during 
the study period.  All paper files and documents will be kept in a locked 
file cabinet, within a locked room.  Electronic records will be kept on a 
password protected computer and only be accessible to study personnel. 
  
2) Long Term Retention 
The investigator will maintain all study records following completion or 
termination of this study in accordance to state law and institutional policy 
(at least 7 years after the study is completed or terminated). 
 
K) Reporting 
 
Progress reports on the investigation shall be submitted to the sponsor and 
the IRB at regular intervals, but in no event less often than yearly. Progress 
reports to the sponsor should follow baseline, 6 month, 1 year, and 2 year 
evaluations. A final study report shall be submitted to the sponsor and IRB 
following termination or completion of the study. Study completion will be 
defined as completing assessments on the last subject and presentation of final 
report 
Unanticipated problems and adverse events will be reported per the Tufts 
MC/TUHS IRB Reportable New Information Policy.  
 
The IRB will be notified of any deviations from the protocol in cases of medical 
emergencies when the change is necessary to eliminate an apparent 
immediate hazard to the subject  
Progress reports on the investigation shall be submitted to the IRB at regular 
intervals, but in no event less often than yearly, e.g., at continuing review. 
 
 
L) Protocol Deviations 

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No protocol changes or deviations will be made without prior agreement by the 
IRB and the study sponsor unless implemented to prevent an immediate 
hazard to subjects.  All other protocol changes or deviations will be made by a 
formal amendment subject to IRB approval and with sponsor agreement.  All 
such changes or deviations will be reported to the IRB as they occur and 
included in the final study report. 
M) Study Termination 
This study may be terminated for the following reasons:  
Discovery of unforeseen risk that could jeopardize the dental/physical 
well-being of subjects. 
Enrollment or recall rates that are not likely to produce sufficient data 
for evaluation of safety and efficacy 
Non-compliance with the clinical investigational plan, the Investigator 
Agreement, applicable FDA regulations or conditions of approval 
imposed by the reviewing IRB 
Withdrawal of IRB approval  
Any other reasons allowed by study agreements/contracts between the 
sponsor and the institution. 
In the event of study termination, the Principal Investigator will determine 
whether subjects are in need of additional treatment and/or follow-up 
observation as a result of participation in this trial. 
 
N) Subject Recruitment/Advertising 
Investigators may also inform clinic patients about the study.  
Investigators may send messages to colleagues via axiUm asking for their help 
in recruiting eligible subjects.  
Likewise, e-mails and/or newsletters that alert the TUSDM community to 
ongoing studies may include information on this study for recruiting purposes.  
Forms of electronic media such as twitter, university websites, Facebook, 
Craiglist, etc. may also be used to recruit. Print media such as the Metro may 
also be used. 
Study personnel may reach out to individuals that have previously expressed 
interest in dental research studies using a phone screening script.  
All of the forms of recruitment will be submitted for IRB approval prior to use.  
A screening interview/questionnaire or screening script will be used for 
recruitment.  
Screen failure data will be retained by PI. Screening ID number and 
demographic information will be recorded.  Identifiable information will not be 
recorded in the screening log. 

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O) References 
1.) Hickel R, Peschke A, Tyas M, Mjör I, Bayne S, Peters M, Hiller KA, Randall 
R, Vanherle G, Heintze SD. FDI World Dental Federation: clinical criteria 
for the evaluation of direct and indirect restorations-update and clinical 
examples. Clin Oral Investig. 2010 Aug;14(4):349-66. Epub 2010 Jul 14. 
 
2.) Bergenholtz G, Cox CF, Loesche WJ, Syed SA. Bacterial leakage around 
dental restorations. Its effect on the pulp. J Oral Pathol 1982: 11(6); 439-
450 
3.) Brannstrom M. communication between the oral cavity and the dental pulp 
associated with restorative treatment. Oper Dent 1984; 9(2);57-68 
4.) Cheung GS. Reducing marginal microleakage of posterior composite resin 
restorations: A review of clinical techniques. J Prothet Dent 1990;63(3): 
286-288. 
5.) Eriksen HM, Pears G. In vitro caries related to marginal leagage around 
composite resin restorations. J Oral Rehabil 1978; 5(1):15-20 
6.) Qvist V. Correlation between marginal adaptation of composite restorations 
and bacterial growth in cavities. Scand J Dent 1980;88:296-300 
7.) Navarro Majo JL. Marginal adaptation of posterior resins: Effect of 
hygroscopic expansion and layer placement technique on Class II and V 
fillings. Stoma (LISB) 1991;2:47-48. 
8.) Saunders WP, Strang R , Ahmad I. effect of composite resin placement and 
use of an unfilled resin on the microleakage of two dentin bonding agents. 
AM J Dent 1990;3(4) :153-156 
9.) Lutz F, Krejci I, Oldenburg TR. Elimination of polymerization stresses at the 
margins of posterior composite resin restorations: A new restorative 
technique. Quint Int 1986;17(12):777-784 
10.) 
Kavo Kerr Group. http://www.kerrdental.com/sonicfill2. Accessed 
August 10, 2015. 
11.) 
Kavo Kerr Group. http://www.kerrdental.com/kerrdental-composites-
sonicfill-2. Accessed August 10, 2015. 
12.) 
Kavo Kerr Group. http://offers.kerrdental.com/optibond-xtr-request-
info?utm_campaign=Optibond+XTR&utm_content=ad2&utm_medium=pp
c&utm_. Accessed August 10, 2015. 
13) 
3M 
ESPE 
http://www.3m.com/3M/en_US/company-us/all-3m-
products/~/filtek-supreme-ultra-Filtek-Supreme-Ultra-Universal-
Restorative?N=5002385+3294736391&rt=rud. Accessed March 30, 2017. 
14)     3M 
ESPE 
http:// 
ww.3m.com/3M/en_US/company-us/all-3m-
products/~/scotchbond-universal-Scotchbond-Universal-
Adhesive?N=5002385+3294776545&rt=rud. Accessed March 30, 2017. 
15) 
ICH Topic 6 (R1) Guideline for Good Clinical Practice CPMP/ICH/135/95 
July 2002. 
 
 

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Appendix A- Hickel Grading Criteria  
 
 
 
 
 
Esthetic Properties 
Functional Properties 
Surface Luster 
Surface 
Staining 
Marginal 
Staining 
Color Match 
and 
Translucency 
Esthetic anatomical 
form 
 
Fracture of 
material and 
retention 
 
Marginal 
adaptation 
 
1. Clinically 
excellent/ very 
good 
 
 
1. Luster 
comparable to 
enamel. 
 
1. No surface 
staining. 
 
 
1. No marginal 
staining. 
 
 
1. Good color 
match, no 
difference in 
shade and/or 
translucency. 
 
 
1. Form is ideal. 
 
 
1. No 
fractures 
/cracks. 
 
 
1. Harmonious 
outline, no 
gaps, no white 
or discolored 
lines. 
 
 
2. Clinically 
good 
(after polishing 
probably very 
good) 
 
 
2.1 Slightly dull, 
not noticeable 
from speaking 
distance. 
2.2 Some 
isolated pores. 
 
2. Minor surface 
staining, easily 
removable by 
polishing. 
 
 
2. Minor 
marginal 
staining, easily 
removable by 
polishing. 
 
 
2. Minor 
deviations in 
shade and/or 
translucency. 
 
2. Form is only slightly 
deviated from the 
normal. 
 
2. Small 
hairline crack. 
 
 
2.1 Marginal 
gap (<150 
μm), white 
lines. 
2.2 Small 
marginal 
fracture 
removable by 
polishing. 
2.3 Slight 
ditching, slight 
step/flashes, 
minor 
irregularities. 
 
 
3. Clinically 
sufficient / 
satisfactory 
(minor 
shortcomings, 
no 
unacceptable 
effects but not 
adjustable w/o 
damage to the 
tooth) 
 
 
3.1 Dull surface 
but acceptable 
if covered with 
film of saliva. 
3.2 Multiple 
pores on more 
than one third 
of surface . 
 
3. Moderate 
surface staining 
that may also 
present on 
other teeth, not 
esthetically 
unacceptable. 
 
 
3. Moderate 
marginal 
staining, not 
esthetically 
unacceptable. 
 
 
3. Distinct 
deviation but 
acceptable. 
Does not affect 
esthetics: 
3.1 more 
opaque 
3.2 more 
translucent 
3.3 darker 
3.4 brighter 
 
3. Form deviates from 
the normal but is 
esthetically 
acceptable. 
 
3. Two or 
more or 
larger hairline 
cracks and/or 
material chip 
fracture not 
affecting the 
marginal 
integrity or 
approximal 
contact. 
 
 
3.1 Gap <250 
μm not 
removable. 
3.2. Several 
small marginal 
fractures. 
3.3 Major 
irregularities, 
ditching or 
flash,steps. 
 
 
4. Clinically 
unsatisfactory 
(but reparable) 
 
 
4.1 Rough 
surface, cannot 
be masked by 
saliva film, 
simple polishing 
is not sufficient. 
Further 
intervention 
necessary. 
4.2 Voids. 
 
4. 
Unacceptable 
surface staining 
on the 
restoration and 
major 
intervention 
necessary for 
improvement. 
 
 
4. Pronounced 
marginal 
staining; major 
intervention 
necessary for 
improvement. 
 
 
4. Localized 
clinically 
deviation that 
can be 
corrected by 
repair: 
4.1 too opaque 
4.2 too 
translucent 
4.3 too dark 
4.4 too bright 
 
4. Form is affected 
and unacceptable 
esthetically. 
Intervention/correction 
is necessary. 
 
4. Material 
chip fractures 
which 
damage 
marginal 
quality or 
approximal 
contacts. 
4.2 Bulk 
fractures with 
partial loss 
(less than 
half of the 
restoration). 
 
 
4.1 Gap >250 
μm or 
dentine/base 
exposed. 
4.2. Severe 
ditching or 
marginal 
fractures. 
4.3 Larger 
irregularities or 
steps (repair 
necessary) 
 
 
5. Clinically 
poor 
(replacement 
necessary) 
 
 
5. Very rough, 
unacceptable 
plaque retentive 
surface. 
 
5. Severe 
surface staining 
and/or 
subsurface 
staining, 
generalized or 
localized, not 
accessible for 
intervention. 
 
 
5. Deep 
marginal 
staining, not 
accessible for 
intervention. 
 
 
5. 
Unacceptable. 
Replacement 
necessary. 
 
 
5. Form is 
unsatisfactory and/or 
lost. Repair not 
feasible/ reasonable. 
Replacement needed. 
 
 
5. (Partial or 
complete) 
loss of 
restoration or 
multiple 
fractures. 
 
5.1 
Restoration 
(complete or 
partial) is 
loose but in 
situ. 
5.2 
Generalized 
major gaps or 
irregularities. 
 

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Functional Properties cont. 
Biological Properties 
 
Radiographic 
examination 
(when 
applicable) 
Patient’s View 
 
Postoperative 
(hypersensitivity 
and tooth 
vitality 
 
Recurrence of 
caries (CAR), 
erosion, 
abfraction 
Tooth integrity 
(enamel cracks, 
tooth fractures) 
Adjacent 
mucosa 
 
1. Clinically 
excellent/ very 
good 
 
 
1. No pathology, 
harmonious 
transition between 
restoration and 
tooth. 
 
 
1. Entirely 
satisfied with 
esthetics and 
function.  
 
 
1. No 
hypersensitivity, 
normal vitality. 
 
 
1. No secondary or 
primary caries. 
 
 
1. Complete 
integrity. 
 
1. Healthy 
mucosa adjacent 
to restoration. 
 
 
2. Clinically 
good 
(after polishing 
probably very 
good) 
 
 
2.1 Acceptable 
material excess 
present.  
2.2 Positive/ 
negative step 
present at margin 
<150 μm. 
 
 
2. Satisfied. 
2.1 Esthetics. 
2.2 Function, 
e.g., minor 
roughness  
 
2. Minor 
hypersensitivity 
for a limited 
period of time, 
normal vitality. 
 
2. Small and 
localized 
1. Demineral-ization 
2. Erosion or 
3. Abfraction. 
 
 
2.1 Small 
Marginal enamel 
fracture (<150 
μm). 
2.2 Hairline crack 
in enamel 
(<150 μm). 
 
 
2. Healthy after 
minor removal of 
mechanical 
irritations 
(plaque, 
calculus, sharp 
edges etc.) 
 
 
3. Clinically 
sufficient / 
satisfactory 
(minor 
shortcomings, no 
unacceptable 
effects but not 
adjustable w/o 
damage to the 
tooth) 
 
 
3. 1 Marginal gap 
< 250 μm. 
3. 2 Negative 
steps visible  
< 250 μm. No 
adverse effects 
noticed. 
3.3 Poor 
radiopacity of 
filling material. 
 
 
3. Minor criticism 
but no adverse 
clinical affects. 
3.1 Esthetic 
shortcomings. 
3.2 Some lack of 
chewing comfort. 
3.3 Unpleasant 
treatment 
procedure.  
 
3.1 Moderate 
hypersensitivity. 
3.2 Delayed/mild 
sensitivity; no 
subjective 
complaints, no 
treatment 
needed. 
 
 
3. Larger areas of  
1.Demineral-ization 
2. Erosion or 
3. 
Abrasion/abfraction, 
dentine not 
exposed. Only 
preventive 
measures 
necessary. 
 
 
3.1 Marginal 
enamel defect 
<250μm 
3.2 Crack 
<250μm; 
3.3 Enamel 
chipping. 
3.4 Multiple 
cracks compared 
to control tooth. 
 
 
3. Alteration of 
mucosa but no 
suspicion of 
causal 
relationship with 
restorative 
material. 
 
4. Clinically 
unsatisfactory 
(but reparable) 
 
 
4.1 Marginal gap 
>250 μm. 
4.2 Material 
excess accessible 
but not 
removable. 
4.3 Negative 
steps >250μm 
and reparable. 
 
 
4. Desire for 
improvement. 
4.1. Esthetics 
4.2 Function, 
e.g., tongue 
irritation. 
Reshaping of 
anatomic form or 
refurbishing is 
possible.  
 
 
4.1 Intense 
hypersensitivity. 
4.2 Delayed with 
minor subjective 
symptoms. 
4.3 No clinical 
detectable 
sensitivity. 
Intervention 
Necessary but 
not replacement. 
 
 
4.1 Caries with 
cavitation and 
suspected 
undermining caries 
4.2 Erosion in 
dentine 
4.3 Abrasion/ 
abfraction in 
dentine. Localized 
and accessible can 
be repaired. 
 
 
4.1 Major 
marginal enamel 
defects; gap >250 
μm or dentine or 
base exposed. 
4.2 Large cracks 
>250 μm, probe 
penetrates. 
4.3. Large enamel 
chipping 
or wall fracture 
 
4. Suspected 
mild allergic, 
lichenoid or toxic 
reaction. 
 
 
5. Clinically 
poor 
(replacement 
necessary) 
 
 
5.1 Secondary 
caries, large gaps, 
large overhangs 
5.2 Apical 
pathology 
5.3 Fracture/loss 
of restoration or 
tooth. 
 
 
5. Completely 
dissatisfied 
and/or adverse 
effects, including 
pain.  
 
 
 
5. Intense, acute 
pulpitis or non 
vital tooth. 
Endodontic 
treatment is 
necessary and 
restoration has to 
be replaced. 
 
 
5. Deep caries or 
exposed 
dentine that is not 
accessible for 
repair of 
restoration. 
 
5. Cusp or tooth 
fracture. 
 
 
5. Suspected 
severe allergic, 
lichenoid or toxic 
reaction.