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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: June 12, 2012
Last verified: June 2012
History of Changes
  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:

MedlinePlus related topics: Tooth Decay
U.S. FDA Resources

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
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: June 12, 2012
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
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on May 23, 2013