Clinical Study on a New Flowable Composite as a Restorative in Adult Teeth
This trial is active, not recruiting.
|Treatments||flowable composite, conventional composite restorative|
|Start date||January 2011|
|End date||September 2013|
|Trial size||60 participants|
|Trial identifier||NCT01369108, CR-10-013|
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|
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||single blind (subject)|
time frame: 24 months
Male or female participants at least 19 years old.
- 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
- 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
|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.|
Call for more information