RECRUITING

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

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Conditions

Dental RestorationDental Veneers

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-08
Study Completion:2028-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07128589

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.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age between 18 -75 years old
  2. * must be willing and able to provide informed consent to participate in the study
  3. * must be available for the required post-operative follow-up study visits
  4. * must be in good general health
  5. * must be in good oral health hygiene (FMPS \< 20%)
  6. * have at least 6 anterior maxillary teeth
  7. * Central and lateral incisors with class IV or Veneer indications. Veneers will be performed exclusively with its contralateral teeth (pairs).
  1. * Single tooth veneers
  2. * Canines
  3. * Periodontal disease
  4. * Pulpal diseases
  5. * Occlusal dysfunctions (end-to-end bite)
  6. * Lack of occlusal stability
  7. * Missing posterior teeth, affecting the occlusal distribution
  8. * Study tooth, adjacent tooth, or opposing tooth with mobility \> grade 2 using the Miller's tooth mobility index
  9. * Systemic or local disorders that contra-indicate the dental procedures needed in this study
  10. * Rampant, uncontrolled caries
  11. * Heavy use of smoking tobacco (1 pack or equivalent a day) or chewing tobacco
  12. * Evidence of xerostomia
  13. * Evidence of severe bruxing or clenching, or in need of Temporomandibular Joint (TMJ) related therapy
  14. * Known allergic reaction and/or sensitivity to research materials being used
  15. * 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
  16. * Tooth surface loss (attrition, erosion, abrasion, or abfraction) on study tooth or adjacent teeth that could impact the perception of pain.
  17. * Taking part in a clinical evaluation of any other dental material
  18. * In the opinion of the Investigator, unsuitable for enrollment in the study for reasons other than those specified in the above exclusion criteria
  19. * Pregnant at the time of enrollment or procedure visit (determined by urine pregnancy test).

Contacts and Locations

Study Contact

Mariana Bucovsky
CONTACT
2129989389
mb10357@nyu.edu
Leticia Arbex
CONTACT
212-998-9202
la1669@nyu.edu

Principal Investigator

Kenneth L Allen, DDS
PRINCIPAL_INVESTIGATOR
NYU College of Dentistry

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: New York University

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08
Study Completion Date2028-09

Study Record Updates

Study Start Date2025-08
Study Completion Date2028-09

Terms related to this study

Additional Relevant MeSH Terms

  • Dental Restoration
  • Dental Veneers