Effect of Silane Coupling on the Clinical Performance of Repaired Composite

Study Overview
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Brief Summary
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Research Problem : Advances in adhesive technologies have introduced several surface treatment concepts that enable the clinician to adhere resin-based composite restorations onto new composite materials. The service life of faulty direct composite restorations can be prolonged by composite repair wherein durable adhesion between old and new resin-based composite materials is established.

Detailed Description
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Objectives : A randomized controlled clinical trial was designed to apply the latest results of evidence-based in vitro studies regarding resin-based repair protocol. The study aimed to assess the effect of adding silane coupling agent as a separate step on the clinical performance of repaired composite restorations and compare the results with those of using the usual etch and bond protocol. Materials and Methods : 45 patients were recruited for this study from patients attending the restorative dentistry clinics for postgraduate students, Jordan University of Science and Technology. Each patient had at least two defected posterior composite restorations that are indicated for repair. With this selection, 116 restorations with localized anatomical deficiencies and/or secondary caries were randomly assigned into three groups according to the type of surface treatment each tooth will receive before the application of the new composite material (Filtek Z250,3M,USA). The teeth in the control group (n = 45): were treated with 37% phosphoric acid etching and conventional one step adhesive (Single Bond,3M,USA). In the Silane-Adhesive group (n = 26): teeth were treated with acid etching and silane coupling agent application (Bis-silane) prior to adhesive bond (Adper single bond). In the Sandblast-Silane-Adhesive group (n = 45): teeth were treated with intra-oral sandblasting and silane coupling agent application (Bis-silane) prior to (Adper Single Bond). The reason of repair, age of old restorations and the location of the restoration-repair interfaces were recorded for every failed restorations. Two examiners followed-up and evaluated the restoration quality after an average of 6 months using modified USPHS criteria. The results of clinical performance were assessed using Chi-square test.

Official Title
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Effect of Silane Coupling Treatment on the Clinical Performance of Direct Repaired Resin-based Composite: A Randomized Controlled Trial.

Conditions
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Defective Composite Restorations

Intervention / Treatment
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* Procedure: composite restoration repair by traditional acid etch treatment procedure and adhesive.
* Procedure: Composite restoration repair by acid etching, silane solution application, and then adhesive.
* Procedure: Composite restoration repair by sandblasting first, then acid etching, silane solution application, and then adhesive.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Deciduous tooth Sustained dentin hypersensitivity Irreversible pulpitis , necrotic, or inadequately-treated endodontic teeth Grossly defective composite restorations that were indicated for replacement. Teeth with compromised periodontal status. Patients with poor oral hygiene Exclusion Criteria: Patients older than 18 years. Asymptomatic restored premolars or molars. Vital or endodontically treated teeth Patients with localized, marginal, anatomical deficiencies and/or carious lesions adjacent to composite restorations or esthetically unpleasant restorations. Teeth with marginal gingivitis but healthy periodontium. Tooth in normal occlusion with antagonist and at least one adjacent tooth.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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
Interventional Model Description: Three groups of patients were randomly assigned to three different treatment protocols of defective composite restoration repair.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control: traditional acid etch treatment group<br>Traditional acid etching to the tooth and old restoration surfaces and then adhesive application. | Procedure: composite restoration repair by traditional acid etch treatment procedure and adhesive.<br>* Recurrent caries surrounding the defective restoration was removed and the surfaces were coditoned with acid and adhesive then new repair composite was addded to repair the old restoration and restore the carious cavity.<br>|
| Experimental: Silane-Adhesive treatment group<br>Acid cid etching of prepared tooth tissues and old restoration surfaces, silane solution application, and then adhesive application. | Procedure: Composite restoration repair by acid etching, silane solution application, and then adhesive.<br>* Recurrent caries surrounding the defective restoration was removed and the surfaces were coditoned with acid, then silane applied, next adhesive then new repair composite was addded to repair the old restoration and restore the carious cavity.<br>|
| Experimental: Sandblast-Silane-Adhesive treatment group<br>First sandblasting the old composite filling surfaces, then acid etching of prepared tooth tissues the restoration, then silane application followed by adhesive application. | Procedure: Composite restoration repair by sandblasting first, then acid etching, silane solution application, and then adhesive.<br>* Recurrent caries surrounding the defective restoration was removed, the old restoration surface were sandblasted, and the tooth and restoration surfaces were coditoned with acid, then silane applied, next adhesive then new repair composite was added to repair the old restoration and restore the carious cavity.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the quality of the repaired restoration retention, colour match, marginal discoloration, marginal adaptation, anatomical form and surface roughness. | Clinical examination and evaluation of the restoration quality according to the United States Public Health Service (USPHS) criteria as Alpha, Bravo and Charlie. Alpha scores mean a better outcome and Charlie scores mean worse outcome. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The presence of postoperative sensitivity. | Patients record their sensitivity in treated teeth and score its intensity on visual analogue scale (VAS) which was divided into 10 digits from 0 to 10 where scores from 0 to less than 5 mean bearable sesitivity and scores from 5 to10 mean unbearable sensitivy outcome. | 2 years. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Silane, Sandblasting of tooth surfaces, Clinical trial, dentine bonding, Composite repair, defective restorations