Effect of Silane Coupling on the Clinical Performance of Repaired Composite

NCT06005571 | Completed

• 1 other identifier: 20220082
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Defective Composite Restorations

Keywords

Silane; Sandblasting of tooth surfaces; Clinical trial; dentine bonding; Composite repair; defective restorations

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The presence of postoperative sensitivity.

  2 years.

Study Arms (3)

Control: traditional acid etch treatment group

ACTIVE COMPARATOR

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.

Silane-Adhesive treatment group

EXPERIMENTAL

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.

Sandblast-Silane-Adhesive treatment group

EXPERIMENTAL

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.

Interventions

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.

Control: traditional acid etch treatment group

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.

Silane-Adhesive treatment group

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.

Sandblast-Silane-Adhesive treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• King Abdullah University Hospital: lead
• Jordan University of Science and Technology: collaborator

Study Sites (1)

Jordan University of Science and Technology

Irbid, 21110, Jordan

Location

Related Publications (1)

• Albashaireh ZSM, Maghaireh GA, Alsaafeen HN. Effects of silane coupling treatment on the clinical performance of direct repaired resin-based composite (RBC) restorations with or without prior surface sandblasting: A randomized controlled trial. J Dent. 2023 Dec;139:104740. doi: 10.1016/j.jdent.2023.104740. Epub 2023 Oct 8.

  PMID: 37816489 DERIVED

MeSH Terms

Interventions

Adhesives

Intervention Hierarchy (Ancestors)

Specialty Uses of Chemicals; Chemical Actions and Uses; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Zakereyya Albashaireh, PhD

  Jordan University of Science and Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The patients who participated in the study and the assessor of the treatment outcome did not know the type of treatment procedure received.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of restorative dentistry

Model Details: Three groups of patients were randomly assigned to three different treatment protocols of defective composite restoration repair.

Study Record Dates

• First Submitted: June 18, 2023
• First Posted: August 22, 2023
• Study Start: March 10, 2022
• Primary Completion: September 30, 2022
• Study Completion: September 15, 2024
• Last Updated: March 6, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

JO (1)