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Effect of Silane Coupling on the Clinical Performance of Repaired Composite

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06005571
Enrollment
43
Registered
2023-08-22
Start date
2022-03-10
Completion date
2024-09-15
Last updated
2025-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Defective Composite Restorations

Keywords

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

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.

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.

Interventions

PROCEDUREcomposite 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.

PROCEDUREComposite 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.

PROCEDUREComposite 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.

Sponsors

Jordan University of Science and Technology
CollaboratorOTHER
King Abdullah University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

The patients who participated in the study and the assessor of the treatment outcome did not know the type of treatment procedure received.

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Assessment of the quality of the repaired restoration retention, colour match, marginal discoloration, marginal adaptation, anatomical form and surface roughness.2 yearsClinical 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

MeasureTime frameDescription
The presence of postoperative sensitivity.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.

Countries

Jordan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026