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

Solventum US LLC

Status

Completed

Conditions

Dental Caries

Treatments

Device: Flowable composite

Device: Conventional composite restorative

Study type

Interventional

Funder types

Industry

Identifiers

NCT01369108

CR-10-013

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

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 Temporomandibular Joint (TMJ) related therapy
is pregnant at time of screening or tooth restoration
has known sensitivity to acrylates or related materials