NCT07128589 3M(TM) Filtek(TM) Supreme Flowable Composites for Class IV and Veneers
| NCT ID | NCT07128589 |
| Status | Recruiting |
| Phase | — |
| Sponsor | New York University |
| Condition | Dental Restoration |
| Study Type | INTERVENTIONAL |
| Enrollment | 75 participants |
| Start Date | 2025-08-07 |
| Primary Completion | 2028-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 75 participants in total. It began in 2025-08-07 with a primary completion date of 2028-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria: * 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 * must be in good oral health hygiene (FMPS \< 20%) * have at least 6 anterior maxillary teeth * Central and lateral incisors with class IV or Veneer indications. Veneers will be performed exclusively with its contralateral teeth (pairs). Exclusion Criteria: * Single tooth veneers * Canines * Periodontal disease * Pulpal diseases * Occlusal dysfunctions (end-to-end bite) * Lack of occlusal stability * Missing posterior teeth, affecting the occlusal distribution * Study tooth, adjacent tooth, or opposing tooth with mobility \> grade 2 using the Miller's tooth mobility index * Systemic or local disorders that contra-indicate the dental procedures needed in this study * Rampant, uncontrolled caries * Heavy use of smoking tobacco (1 pack or equivalent a day) or chewing tobacco * Evidence of xerostomia * Evidence of severe bruxing or clenching, or in need of Temporomandibular Joint (TMJ) related therapy * Known allergic reaction and/or sensitivity to research materials being used * Condition or history of chronic use of anti-inflammatory, analgesic (pain), and/or mind altering drugs for medical (including psychiatric) and pharmacotherapeutic therapies that might alter the perception of pain * Tooth surface loss (attrition, erosion, abrasion, or abfraction) on study tooth or adjacent teeth that could impact the perception of pain. * Taking part in a clinical evaluation of any other dental material * In the opinion of the Investigator, unsuitable for enrollment in the study for reasons other than those specified in the above exclusion criteria * Pregnant at the time of enrollment or procedure visit (determined by urine pregnancy test).
Contact & Investigator
Kenneth L Allen, DDS
PRINCIPAL INVESTIGATOR
NYU College of Dentistry
Frequently Asked Questions
Who can join the NCT07128589 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Dental Restoration. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07128589 currently recruiting?
Yes, NCT07128589 is actively recruiting participants. Contact the research team at mb10357@nyu.edu for enrollment information.
Where is the NCT07128589 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT07128589 clinical trial?
NCT07128589 is sponsored by New York University. The principal investigator is Kenneth L Allen, DDS at NYU College of Dentistry. The trial plans to enroll 75 participants.