RECRUITING

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

Description

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.

Conditions

Dental RestorationDental Veneers
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Related Conditions:

Dental RestorationDental Veneers

Study Overview

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Study Details

Study overview

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.

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

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

Condition
Dental Restoration
Intervention / Treatment

-

Contacts and Locations

New York

NYU College Of Dentistry, New York, New York, United States, 10010

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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).
  • * 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).

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

New York University,

Kenneth L Allen, DDS, PRINCIPAL_INVESTIGATOR, NYU College of Dentistry

Study Record Dates

2028-09