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

Solventum US LLC60 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Dental Caries

Interventions

Flowable compositeDEVICE

Restoration of small Class V and I cavities in molar and premolar teeth

Conventional composite restorativeDEVICE

Restoration of small Class V and I cavities in molar and premolar teeth

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Alabama at Birmingham School of Dentistry, 605 School of Dentistry Building, 1919 7th Avenue South

Birmingham, Alabama, United States

Outcomes

Primary Outcomes

Clinical Performance by Cvar & Ryge Scores

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).

Time frame: baseline, 6, 12 and 24 months

Clinical Performance by VAS (Pain Scale)

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.

Time frame: baseline, 6, 12 and 24 months

Data from ClinicalTrials.gov

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