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

Not Applicable

Completed

Interventions: Device: Conventional composite restorative
Device: Flowable composite

Brief 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.

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.

Recruitment & Eligibility

Inclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
Conventional composite	Conventional composite restorative	Highly filled conventional composite restorative
Flowable composite	Flowable composite	Flowable composite

Primary Outcome Measures

Name	Time	Method
Clinical Performance by VAS (Pain Scale)	baseline, 6, 12 and 24 months	Sensitivity to cold was measured by applying a cotton pellet soaked with pulp vitality refrigerant spray (Endo Ice, Coltene/ Whaledent, Cuyahoga Falls, OH, USA) to the tooth for three seconds. Sensitivity to biting was measured by having the patient bite on a cotton roll for five seconds. After each test, the subject was asked to place an ''X'' on a 10-mm line labeled ''1'' on the left and ''10'' on the right. Patients were told that a ''10'' represents the worst pain they can imagine (ie, childbirth, major surgery, or kidney stone) and that ''1'' represents no sensation at all.
Clinical Performance by Cvar & Ryge Scores	baseline, 6, 12 and 24 months	Clinical performance reported on 6 parameters as the % of teeth with perfect scores ("A" rating). Cvar \& Ryge scores measure 6 parameters: Anatomic form (rated A,B= satisfactory, C=unsatisfactory); Color Match (A=match, B=mismatch, but within normal, C=mismatch outside normal); Marginal Adaptation (A=no visible crevice, B=no exposure of dentin, C=defect to enamel-dentine junction, D= fracture, missing); Marginal Discoloration (A=none, B= marginal discoloration, C=marginal discoloration to pulpal direction); Surface Integrity (A=smooth, B=slight rough, C=Pitted, D=fracture)'Secondary caries (A=none, D=present).

Secondary Outcome Measures

Name	Time	Method

Locations (1): University of Alabama at Birmingham School of Dentistry, 605 School of Dentistry Building, 1919 7th Avenue South
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Birmingham, Alabama, United States