Dental Restoration Failure of Marginal IntegrityNCT02572570

Clinical Investigation of a New Bulk Fill Composite Resin in the Restoration of Posterior Teeth

A study testing Filtek Bulk Fill Posterior and Filtek Supreme Ultra in people with Dental Restoration Failure of Marginal Integrity and Dental Caries, run by University of North Carolina, Chapel Hill at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 to 99 yearsHealthy volunteers can take part
Conditions the study is for: Dental Restoration Failure of Marginal Integrity, Dental Caries, Unrepairable Overhanging of Dental Restorative Materials
What is being tested?: Filtek Bulk Fill Posterior and Filtek Supreme Ultra
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 27 participants
Where: 1 siteUnited States
Study dates: Dec 2015to 5 Dec 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 99 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Be 18 years of age and older
Have a pair of similar cavities or failed dental fillings in vital permanent posterior teeth requiring treatment
Be capable of giving written informed consent.

Who cannot join

Have a self-reported history of any adverse reaction to materials of the types to be evaluated
Have a medical or dental history that could possibly complicate the provision of the proposed treatment and/or influence the behavior and performance of the treatment in clinical service.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of North Carolina at Chapel Hill School of Dentistry
Chapel Hill, North Carolina, 27599

Other trials in United States

About this study

Polymerization shrinkage remains one of the primary disadvantages of composite resin restorative materials (tooth-colored fillings). To minimize the effects of polymerization shrinkage in the restorative treatment, the 3M ESPE company has developed a composite resin called Filtek Bulk Fill Posterior Restorative. Its decreased polymerization shrinkage and properties allow the material to be inserted in one single increment, expediting treatment. This clinical trial is designed to evaluate the performance of the new bulk fill composite resin in Class II (two-surface posterior) fillings.

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
Being tested: Filtek Bulk Fill Posterior, Filtek Supreme Ultra
Keywords: Adult dental care
Medical subject headings: Dental Caries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Filtek Bulk Fill PosteriorDevice
Also called Dental filling
Tooth (teeth) affected by dental caries or with an existing defective filling restored using the materials listed (Filtek Bulk Fill Posterior). Procedures done using local anesthesia and following ordinary restorative techniques.
Filtek Supreme UltraDevice
Also called Dental filling
Tooth (teeth) affected by dental caries or with an existing defective filling restored using the materials listed (Filtek Supreme Ultra). Procedures done using local anesthesia and following ordinary restorative techniques.

Study groups in NCT02572570
Study group	Role	What they receive
Posterior Composite Resin Restoration	Experimental	Participants will receive two commercially available tooth-colored restorative materials used for direct restoration as per manufacturer's instructions. Receives: Device: Filtek Bulk Fill Posterior; Device: Filtek Supreme Ultra

What is being measured

The primary outcome is the main question the study is designed to answer.

Restoration Percent Success at Day 1
The World Dental Federation (FDI) rates 16 categories on a scale of 1 to 5 with 1 being "Clinically Excellent" and 5 being "Clinically Poor". Scores 1-3 were considered clinically acceptable while scores 4 and 5 were considered failures. Cases were considered successful if each of the 16 following FDI criteria presented an individual score of 3 or less:
A.Esthetic Properties Surface lustre [Item 1] Surface staining [Item 2] Color stability and translucency [Item 3] Anatomic form [Item 4] B.Functional Properties Fractures and retention [Item 5] Marginal adaptation [Item 6] Wear [Item 7] Contact point/food impact [Item 8] Radiographic examination [Item 9] Patient's view [Item 10] C.Biological Properties Postoperative (hyper)sensitivity and tooth vitality [Item 11] Recurrence of caries, erosion, abfraction [Item 12] Tooth integrity [Item 13] Periodontal response [Item 14] Adjacent mucosa [Item 15] Oral and general health [Item 16]
Measured: Assessed immediately post restoration placement completion
Restoration Percent Success at Year 1
The World Dental Federation (FDI) rates 16 categories on a scale of 1 to 5 with 1 being "Clinically Excellent" and 5 being "Clinically Poor". Scores 1-3 were considered clinically acceptable while scores 4 and 5 were considered failures. Cases were considered successful if each of the 16 following FDI criteria presented an individual score of 3 or less:
A.Esthetic Properties
- Surface lustre [Item 1]
- Surface staining [Item 2]
- Color stability and translucency [Item 3]
- Anatomic form [Item 4]
B.Functional Properties
- Fractures and retention [Item 5]
- Marginal adaptation [Item 6]
- Wear [Item 7]
- Contact point/food impact [Item 8]
- Radiographic examination [Item 9]
- Patient's view [Item 10]
C.Biological Properties
- Postoperative (hyper)sensitivity and tooth vitality [Item 11]
- Recurrence of caries, erosion, abfraction [Item 12]
- Tooth integrity [Item 13]
- Periodontal response [Item 14]
- Adjacent mucosa [Item 15]
- Oral and general health [Item 16]
Measured: Year 1
Restoration Percent Success at Year 2
The FDI rates 16 categories on a scale of 1 to 5 with 1 being "Clinically Excellent" and 5 being "Clinically Poor". Scores 1-3 were considered clinically acceptable while scores 4 and 5 were considered failures. Cases were considered successful if each of the 16 following FDI criteria presented an individual score of 3 or less:
A.Esthetic Properties
- Surface lustre [Item 1]
- Surface staining [Item 2]
- Color stability and translucency [Item 3]
- Anatomic form [Item 4]
B.Functional Properties
- Fractures and retention [Item 5]
- Marginal adaptation [Item 6]
- Wear [Item 7]
- Contact point/food impact [Item 8]
- Radiographic examination [Item 9]
- Patient's view [Item 10]
C.Biological Properties
- Postoperative (hyper)sensitivity and tooth vitality [Item 11]
- Recurrence of caries, erosion, abfraction [Item 12]
- Tooth integrity [Item 13]
- Periodontal response [Item 14]
- Adjacent mucosa [Item 15]
- Oral and general health [Item 16]
Measured: Year 2
Restoration Percent Success at Year 3
The FDI rates 16 categories on a scale of 1 to 5 with 1 being "Clinically Excellent" and 5 being "Clinically Poor". Scores 1-3 were considered clinically acceptable while scores 4 and 5 were considered failures. Cases were considered successful if each of the 16 following FDI criteria presented an individual score of 3 or less:
A.Esthetic Properties
- Surface lustre [Item 1]
- Surface staining [Item 2]
- Color stability and translucency [Item 3]
- Anatomic form [Item 4]
B.Functional Properties
- Fractures and retention [Item 5]
- Marginal adaptation [Item 6]
- Wear [Item 7]
- Contact point/food impact [Item 8]
- Radiographic examination [Item 9]
- Patient's view [Item 10]
C.Biological Properties
- Postoperative (hyper)sensitivity and tooth vitality [Item 11]
- Recurrence of caries, erosion, abfraction [Item 12]
- Tooth integrity [Item 13]
- Periodontal response [Item 14]
- Adjacent mucosa [Item 15]
- Oral and general health [Item 16]
Measured: Year 3
Restoration Percent Success at Year 5
The FDI rates 16 categories on a scale of 1 to 5 with 1 being "Clinically Excellent" and 5 being "Clinically Poor". Scores 1-3 were considered clinically acceptable while scores 4 and 5 were considered failures. Cases were considered successful if each of the 16 following FDI criteria presented an individual score of 3 or less:
A.Esthetic Properties
- Surface lustre [Item 1]
- Surface staining [Item 2]
- Color stability and translucency [Item 3]
- Anatomic form [Item 4]
B.Functional Properties
- Fractures and retention [Item 5]
- Marginal adaptation [Item 6]
- Wear [Item 7]
- Contact point/food impact [Item 8]
- Radiographic examination [Item 9]
- Patient's view [Item 10]
C.Biological Properties
- Postoperative (hyper)sensitivity and tooth vitality [Item 11]
- Recurrence of caries, erosion, abfraction [Item 12]
- Tooth integrity [Item 13]
- Periodontal response [Item 14]
- Adjacent mucosa [Item 15]
- Oral and general health [Item 16]
Measured: Year 5

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 20155 Dec 2019

First posted9 Oct 2015 (estimated)
Study startDec 2015
Primary completion5 Dec 2019
Study completion5 Dec 2019

Why it stopped: Attrition rate complicated by COVID-19 led to termination.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Dental Restoration Failure of Marginal IntegrityStudies of the same condition, open and under way.
More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 27 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02572570
Sponsor's protocol ID: 14-3097
Status last verified: Oct 2020
First submitted: 21 Sep 2015
Last updated: 19 Dec 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Clinical Evaluation of Short Dentin Etching
Hypersensitivity Dentin, Dental Restoration Failure of Marginal Integrity
Active, not recruiting
Clinical Evaluation of Bulk Fill Composite Restorations Associated to Universal Adhesive System
Dental Restoration Failure of Marginal Integrity
Active, not recruiting
Different Application Strategies When Using Futurabond Universal in Class V Cavities
Dental Restoration Failure of Marginal Integrity
Recruiting
Clinical Performance of Full Coverage Hybrid Ceramic Crowns in the Aesthetic Zone: A Randomized Clinical Trial
Dental Restoration Failure of Marginal Integrity, Poor Aesthetic of Existing Restoration of Tooth
Active, not recruiting
Comparative Evaluation of Class V Restorations
Secondary Caries, Dental Restoration Failure of Marginal Integrity

All Dental Restoration Failure of Marginal Integrity trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Investigation of a New Bulk Fill Composite Resin in the Restoration of Posterior Teeth
ClinicalTrials.gov ID: NCT02572570
Acronym / sponsor ID: 14-3097
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
Keywords: Adult dental care
Study type: Interventional
Recruitment status: TerminatedReason stopped: Attrition rate complicated by COVID-19 led to termination.
Enrolment: 27 participants (actual)
Lead sponsor: University of North Carolina, Chapel HillUniversity, hospital or other
Collaborators: 3M ESPE
Study start: Dec 2015
Primary completion: 5 Dec 2019 (actual)
Study completion: 5 Dec 2019 (actual)
First posted: 9 Oct 2015 (estimated)
Results: Posted 19 Dec 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Posterior Composite Resin Restoration	Experimental	Device: Filtek Bulk Fill Posterior, Device: Filtek Supreme UltraParticipants will receive two commercially available tooth-colored restorative materials used for direct restoration as per manufacturer's instructions.

Who may qualify

Ages: 18 to 99 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Be 18 years of age and older
Have a pair of similar cavities or failed dental fillings in vital permanent posterior teeth requiring treatment
Be capable of giving written informed consent.

Key exclusion criteria (2 listed)

Have a self-reported history of any adverse reaction to materials of the types to be evaluated
Have a medical or dental history that could possibly complicate the provision of the proposed treatment and/or influence the behavior and performance of the treatment in clinical service.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Filtek Bulk Fill PosteriorAlso: Dental fillingTooth (teeth) affected by dental caries or with an existing defective filling restored using the materials listed (Filtek Bulk Fill Posterior). Procedures done using local anesthesia and following ordinary restorative techniques.	Device	Posterior Composite Resin Restoration
Filtek Supreme UltraAlso: Dental fillingTooth (teeth) affected by dental caries or with an existing defective filling restored using the materials listed (Filtek Supreme Ultra). Procedures done using local anesthesia and following ordinary restorative techniques.	Device	Posterior Composite Resin Restoration

Primary outcome

Restoration Percent Success at Day 1
Time frame: Assessed immediately post restoration placement completion
The World Dental Federation (FDI) rates 16 categories on a scale of 1 to 5 with 1 being "Clinically Excellent" and 5 being "Clinically Poor". Scores 1-3 were considered clinically acceptable while scores 4 and 5 were considered failures. Cases were considered successful if each of the 16 following FDI criteria presented an individual score of 3 or less: A.Esthetic Properties Surface lustre [Item 1] Surface staining [Item 2] Color stability and translucency [Item 3] Anatomic form [Item 4] B.Functional Properties Fractures and retention [Item 5] Marginal adaptation [Item 6] Wear [Item 7] Contact point/food impact [Item 8] Radiographic examination [Item 9] Patient's view [Item 10] C.Biological Properties Postoperative (hyper)sensitivity and tooth vitality [Item 11] Recurrence of caries, erosion, abfraction [Item 12] Tooth integrity [Item 13] Periodontal response [Item 14] Adjacent mucosa [Item 15] Oral and general health [Item 16]
Restoration Percent Success at Year 1
Time frame: Year 1
The World Dental Federation (FDI) rates 16 categories on a scale of 1 to 5 with 1 being "Clinically Excellent" and 5 being "Clinically Poor". Scores 1-3 were considered clinically acceptable while scores 4 and 5 were considered failures. Cases were considered successful if each of the 16 following FDI criteria presented an individual score of 3 or less: A.Esthetic Properties * Surface lustre [Item 1] * Surface staining [Item 2] * Color stability and translucency [Item 3] * Anatomic form [Item 4] B.Functional Properties * Fractures and retention [Item 5] * Marginal adaptation [Item 6] * Wear [Item 7] * Contact point/food impact [Item 8] * Radiographic examination [Item 9] * Patient's view [Item 10] C.Biological Properties * Postoperative (hyper)sensitivity and tooth vitality [Item 11] * Recurrence of caries, erosion, abfraction [Item 12] * Tooth integrity [Item 13] * Periodontal response [Item 14] * Adjacent mucosa [Item 15] * Oral and general health [Item 16]
Restoration Percent Success at Year 2
Time frame: Year 2
The FDI rates 16 categories on a scale of 1 to 5 with 1 being "Clinically Excellent" and 5 being "Clinically Poor". Scores 1-3 were considered clinically acceptable while scores 4 and 5 were considered failures. Cases were considered successful if each of the 16 following FDI criteria presented an individual score of 3 or less: A.Esthetic Properties * Surface lustre [Item 1] * Surface staining [Item 2] * Color stability and translucency [Item 3] * Anatomic form [Item 4] B.Functional Properties * Fractures and retention [Item 5] * Marginal adaptation [Item 6] * Wear [Item 7] * Contact point/food impact [Item 8] * Radiographic examination [Item 9] * Patient's view [Item 10] C.Biological Properties * Postoperative (hyper)sensitivity and tooth vitality [Item 11] * Recurrence of caries, erosion, abfraction [Item 12] * Tooth integrity [Item 13] * Periodontal response [Item 14] * Adjacent mucosa [Item 15] * Oral and general health [Item 16]
Restoration Percent Success at Year 3
Time frame: Year 3
The FDI rates 16 categories on a scale of 1 to 5 with 1 being "Clinically Excellent" and 5 being "Clinically Poor". Scores 1-3 were considered clinically acceptable while scores 4 and 5 were considered failures. Cases were considered successful if each of the 16 following FDI criteria presented an individual score of 3 or less: A.Esthetic Properties * Surface lustre [Item 1] * Surface staining [Item 2] * Color stability and translucency [Item 3] * Anatomic form [Item 4] B.Functional Properties * Fractures and retention [Item 5] * Marginal adaptation [Item 6] * Wear [Item 7] * Contact point/food impact [Item 8] * Radiographic examination [Item 9] * Patient's view [Item 10] C.Biological Properties * Postoperative (hyper)sensitivity and tooth vitality [Item 11] * Recurrence of caries, erosion, abfraction [Item 12] * Tooth integrity [Item 13] * Periodontal response [Item 14] * Adjacent mucosa [Item 15] * Oral and general health [Item 16]
Restoration Percent Success at Year 5
Time frame: Year 5
The FDI rates 16 categories on a scale of 1 to 5 with 1 being "Clinically Excellent" and 5 being "Clinically Poor". Scores 1-3 were considered clinically acceptable while scores 4 and 5 were considered failures. Cases were considered successful if each of the 16 following FDI criteria presented an individual score of 3 or less: A.Esthetic Properties * Surface lustre [Item 1] * Surface staining [Item 2] * Color stability and translucency [Item 3] * Anatomic form [Item 4] B.Functional Properties * Fractures and retention [Item 5] * Marginal adaptation [Item 6] * Wear [Item 7] * Contact point/food impact [Item 8] * Radiographic examination [Item 9] * Patient's view [Item 10] C.Biological Properties * Postoperative (hyper)sensitivity and tooth vitality [Item 11] * Recurrence of caries, erosion, abfraction [Item 12] * Tooth integrity [Item 13] * Periodontal response [Item 14] * Adjacent mucosa [Item 15] * Oral and general health [Item 16]

Results and safety

Results posted to the registry on 19 Dec 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Posterior Composite Resin Restoration	27	0

Primary outcome: Restoration Percent Success at Day 1

Time frame: Assessed immediately post restoration placement completion. Number. Unit: percentage of scores =/<3

Measure	Filtek Bulk Fill Posterior n = 27	Filtek Supreme Ultra n = 27
Value	100	100

Primary outcome: Restoration Percent Success at Year 1

Time frame: Year 1. Number. Unit: percentage of scores =/<3

Measure	Filtek Bulk Fill Posterior n = 20	Filtek Supreme Ultra n = 20
Esthetic Properties	100	96
Functional Properties	96	96
Biological Properties	96	100

Population analysed: Esthetic and Functional Property data not collected for 1 restoration that was replaced due to sensitivity prior to assessment visit.

Primary outcome: Restoration Percent Success at Year 2

Time frame: Year 2. Number. Unit: percentage of scores =/<3

Measure	Filtek Bulk Fill Posterior n = 13	Filtek Supreme Ultra n = 13
Esthetic Properties	94	100
Functional Properties	100	88
Biological Properties	100	100

Population analysed: Esthetic and Biological Property data not collected for 1 restoration due to tooth fracture resulting in full coverage restoration.

Primary outcome: Restoration Percent Success at Year 3

Time frame: Year 3. Number. Unit: percentage of scores =/<3

Measure	Filtek Bulk Fill Posterior n = 5	Filtek Supreme Ultra n = 5
Esthetic Properties	67	100
Functional Properties	100	67
Biological Properties	100	100

Population analysed: Esthetic and Biological Property data not collected for 1 restoration due to tooth fracture resulting in full coverage restoration prior to Year 2 assessment.

Adverse events

Time frame: From time of restoration through last follow-up visit, a planned total of up to 5 years although the trial was terminated early, thus the maximum participant follow-up was through Year 3.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Filtek Bulk Fill Posterior	3 of 27 (11.1%)	7 of 27 (25.9%)	0 of 27
Filtek Supreme Ultra	3 of 27 (11.1%)	6 of 27 (22.2%)	0 of 27
All Participants	3 of 27 (11.1%)	7 of 27 (25.9%)	0 of 27

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Rick Walter, DDS principal investigator

University of North Carolina, Chapel Hill

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 19 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Restoration Percent Success at Day 1 (time frame: Assessed immediately post restoration placement completion). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02572570.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2020.