Overview

This trial is active, not recruiting.

Condition dental caries
Treatments flowable composite, conventional composite restorative
Sponsor 3M
Start date January 2011
End date September 2013
Trial size 60 participants
Trial identifier NCT01369108, CR-10-013

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Experimental)
Flowable composite
flowable composite Filtek Supreme Ultra Flowable Restorative 3M ESPE)
Restoration of small Class V and I cavities in molar and premolar teeth
(Active Comparator)
Highly filled conventional composite restorative
conventional composite restorative
Restoration of small Class V and I cavities in molar and premolar teeth

Primary Outcomes

Measure
Clinical performance
time frame: 24 months

Eligibility Criteria

Male or female participants at least 19 years old.

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

Additional Information

Official title Clinical Evaluation of a Low Shrinkage Flowable Resin Composite in Adult Teeth
Principal investigator John O Burgess, DDS, MS
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2013.
Information provided to ClinicalTrials.gov by 3M.