Effect of Silane Coupling on the Clinical Performance of Repaired Composite

March 4, 2024 updated by: Zakereyya Albashaireh, King Abdullah University Hospital

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

43

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Jordan
      • Irbid, Jordan, 21110
        • Jordan University of Science and Technology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control: traditional acid etch treatment group
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.
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.
Experimental: Silane-Adhesive treatment group
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.
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.
Experimental: Sandblast-Silane-Adhesive treatment group
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.
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.

What is the study measuring?

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.
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.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King Abdullah University Hospital

Collaborators

Jordan University of Science and Technology

Investigators

  • Principal Investigator: Zakereyya Albashaireh, PhD, Jordan University of Science and Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 10, 2022

Primary Completion (Actual)

September 30, 2022

Study Completion (Estimated)

September 15, 2024

Study Registration Dates

First Submitted

June 18, 2023

First Submitted That Met QC Criteria

August 21, 2023

First Posted (Actual)

August 22, 2023

Study Record Updates

Last Update Posted (Actual)

March 5, 2024

Last Update Submitted That Met QC Criteria

March 4, 2024

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20220082

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

A consent has to be obtained from the faculty of graduate studies for sharing data as data form part of graduate students thesis.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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