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Completed

NCT Number: NCT06005571

Effect of Silane Coupling on the Clinical Performance of Repaired Composite

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jordan University of Science and Technology

Irbid, 21110, Jordan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Procedure

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.

Composite restoration repair by acid etching, silane solution application, and then adhesive.

Procedure

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.

Composite restoration repair by sandblasting first, then acid etching, silane solution application, and then adhesive.

Procedure

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.

Primary outcomes

  1. Assessment of the quality of the repaired restoration retention, colour match, marginal discoloration, marginal adaptation, anatomical form and surface roughness.

    Time frame: 2 years

    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.

Secondary outcomes

  1. The presence of postoperative sensitivity.

    Time frame: 2 years.

    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.

Sponsors and collaborators

Lead sponsor

King Abdullah University Hospital

Other

Collaborators

  • Jordan University of Science and Technology

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2024
First posted
Aug 22, 2023
Registry last updated
Mar 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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