Health TrialsbyHealthPanel

3M(TM) Filtek(TM) Supreme Flowable Composites for Class IV and Veneers

ConditionsDental RestorationDental Veneers
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorNew York University

About this trial

This clinical study aims to evaluate the clinical performance of 3M™ Filtek™ Supreme Flowable Composite in class IV and veneer indication. Follow-ups of 7 days, 6, 12, and 24 months will be conducted following an Fédération Dentaire Internationale (FDI) modified score (2023). A minimum of 50 Class IV and 25 veneers will be included in the evaluation. Research data and pictures will be provided for each patient pre-op and at 7 days (baseline, 6 months, 12 months and 24 months. Evaluation will be conducted by two calibrated evaluators different from the operator according to FDI clinical criteria.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age between 18 -75 years old

must be willing and able to provide informed consent to participate in the study

must be available for the required post-operative follow-up study visits

must be in good general health

Disqualifiers

Single tooth veneers

Canines

Periodontal disease

Pulpal diseases

Trial design

Design model

Parallel

Treatments tested in this trial

  • 3MTM FiltekTM Supreme Flowable Composite

    Device

    3M ™ Supreme Flowable Restorative contains BisGMA,TEGDMA and Procrylat resins. The fillers are a combination of ytterbium trifluoride filler with a range of particles sizes from 0.1 to 5.0 microns, a non-agglomerated/non-aggregated surface modified 20nm silica filler, a non-agglomerated/non/aggregated surface modified 75nm silica filler, and a surface modified aggregated zirconia/silica cluster filler (comprised of 20 nm silica and 4 to 11nm zirconia particles). The aggregate has an average cluster particle size of 0.6 to 10 microns. The inorganic filler loading is approximately 65% by weight (46% by volume). 3M (TM) Filtek(TM) Supreme Flowable Restorative is a modification of predicate device 3M(TM) Filtek(TM) XT Flowable Restorative (which was a modification of 3M(TM) Filtek(TM) Flow. 3M Filtek Supreme Flowable Composites are used per indication and its approved labeling in this study.

Treatment groups

75 Participants
are divided into 2 treatment groups
Group A: Class IV RestorationExperimental treatment 1 intervention
Group B: VeneersExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Survival of treated site over 24 months

Primary site survival will be based off of an Modified FDI criteria score greater or equal to 4.

Time frame
24 months

Secondary outcomes

1

Esthetic Properties evaluation

Esthetic quality scores measured on an ordinal scale of 1-5.

Time frame
24 months
2

Functional Properties evaluation

Functional Properties scores measured on an ordinal scale of 1-5.

Time frame
24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

New York University

Lead sponsor

Source ClinicalTrials.gov
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