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Effect of Silane Coupling on the Clinical Performance of Repaired Composite

K

King Abdullah University Hospital

Status

Completed

Conditions

Defective Composite Restorations

Treatments

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.
Procedure: composite restoration repair by traditional acid etch treatment procedure and adhesive.

Study type

Interventional

Funder types

Other

Identifiers

NCT06005571
20220082

Details and patient eligibility

About

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.

Full description

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.

Enrollment

43 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

43 participants in 3 patient groups

Control: traditional acid etch treatment group
Active Comparator group
Description:
Traditional acid etching to the tooth and old restoration surfaces and then adhesive application.
Treatment:
Procedure: composite restoration repair by traditional acid etch treatment procedure and adhesive.
Silane-Adhesive treatment group
Experimental group
Description:
Acid cid etching of prepared tooth tissues and old restoration surfaces, silane solution application, and then adhesive application.
Treatment:
Procedure: Composite restoration repair by acid etching, silane solution application, and then adhesive.
Sandblast-Silane-Adhesive treatment group
Experimental group
Description:
First sandblasting the old composite filling surfaces, then acid etching of prepared tooth tissues the restoration, then silane application followed by adhesive application.
Treatment:
Procedure: Composite restoration repair by sandblasting first, then acid etching, silane solution application, and then adhesive.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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