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Clinical Study on a New Flowable Composite as a Restorative in Adult Teeth

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
3M
ClinicalTrials.gov Identifier:
NCT01369108
First received: June 7, 2011
Last updated: July 10, 2013
Last verified: July 2013
  Purpose

Study hypothesis: a new, low polymerization stress flowable composite performs no differently to a conventional, highly filled composite filling material when used as a restorative in small cavities in back teeth.

Study will evaluate the clinical performance of a low shrinking flowable composite filling material, compared with a conventional, highly filled composite restorative when used to permanently fill small cavities in molar and premolar teeth in adult patients.


Condition Intervention
Dental Caries
Device: Flowable composite
Device: Conventional composite restorative

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of a Low Shrinkage Flowable Resin Composite in Adult Teeth

Resource links provided by NLM:


Further study details as provided by 3M:

Primary Outcome Measures:
  • Clinical performance [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Efficiency of flowable composite in clinical service in restoration of small Class I lesions over a 24 month time frame


Estimated Enrollment: 60
Study Start Date: January 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Flowable composite
Flowable composite
Device: Flowable composite
Restoration of small Class V and I cavities in molar and premolar teeth
Other Name: Filtek Supreme Ultra Flowable Restorative 3M ESPE)
Active Comparator: Conventional composite
Highly filled conventional composite restorative
Device: Conventional composite restorative
Restoration of small Class V and I cavities in molar and premolar teeth

Detailed Description:

The study will evaluate clinical performance of a low shrink flowable composite filling material and compare it with a conventional, highly filled composite. The study materials will be used to restore small cavities in molar and premolar teeth in adult patients.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 19 years or older
  • must give written consent
  • be in good general health
  • be available for required follow-up visits
  • have at least 28 teeth

Exclusion Criteria:

  • has rampant, uncontrolled caries
  • has advanced, untreated periodontal disease
  • heavy use of smoking tobacco (2 packs or equivalent a day)or chewing tobacco
  • has systemic or local disorders that contra-indicate the dental procedures needed in this study
  • has evidence of xerostomia
  • has evidence of severe bruxing or clenching, or in need of TMJ related therapy
  • is pregnant at time of screening or tooth restoration
  • has known sensitivity to acrylates or related materials
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01369108

Locations
United States, Alabama
University of Alabama at Birmingham School of Dentistry, 605 School of Dentistry Building, 1919 7th Avenue South
Birmingam, Alabama, United States, 35233-2005
Sponsors and Collaborators
3M
Investigators
Principal Investigator: John O Burgess, DDS, MS Unversity of Alabama at Birmingam Dental School
  More Information

No publications provided

Responsible Party: 3M
ClinicalTrials.gov Identifier: NCT01369108     History of Changes
Other Study ID Numbers: CR-10-013
Study First Received: June 7, 2011
Last Updated: July 10, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by 3M:
small Class I
molar and premolar
low stress flowable composite
adult
Restoration
small caries lesions

Additional relevant MeSH terms:
Dental Caries
Stomatognathic Diseases
Tooth Demineralization
Tooth Diseases

ClinicalTrials.gov processed this record on November 20, 2014