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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Clinical Evaluation of a Low Shrinkage Flowable Resin Composite in Adult Teeth

Conditions
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Dental Caries

Intervention / Treatment
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* Device: Flowable composite
* Device: Conventional composite restorative


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Flowable composite<br>Flowable composite | Device: Flowable composite<br>* Restoration of small Class V and I cavities in molar and premolar teeth<br>* Other names: Filtek Supreme Ultra Flowable Restorative 3M ESPE);|
| Active Comparator: Conventional composite<br>Highly filled conventional composite restorative | Device: Conventional composite restorative<br>* Restoration of small Class V and I cavities in molar and premolar teeth<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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. | baseline, 6, 12 and 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adult, small Class I, molar and premolar, low stress flowable composite, Restoration, small caries lesions