3M Filtek Supreme Flowable Composite for front-tooth repairs and veneers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional clinical evaluation will place Filtek Supreme Flowable Composite restorations for class IV defects and paired veneers and follow patients at 7 days, 6, 12, and 24 months using a modified FDI scoring system. A minimum of 50 class IV restorations and 25 veneer cases will be included, with standardized photos taken pre-op and at each follow-up. Two calibrated evaluators, not the operator, will score outcomes according to FDI clinical criteria. All treatments and follow-up visits are planned at NYU College of Dentistry.

Why it matters

Who can join: the full rules

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).

Where it's running

• NYU College Of Dentistry
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Kenneth L Allen, DDS — NYU College of Dentistry
• Study coordinator: Mariana Bucovsky
• Email: mb10357@nyu.edu
• Phone: 2129989389

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.