Composite Repair Using Silane Coupling Agent

Clinical Performance of Repaired Resin Composite Restorations Using Separate Silane Coupling Agent Versus Adhesives Containing Regular or Acid Resistance Silane: A Randomized Controlled Trial

Evaluation the influence of the use of silane coupling agent application as a separate step versus application of silane or acid resistance silane containing adhesives on the clinical performance of repaired posterior resin composite restorations according to Modified United States Public Health Service (USPHS) criteria over one year.

Study Overview

• Status: Not yet recruiting
• Conditions: Hypersensitivity; Tooth Discoloration; Dental Restoration Failure of Marginal Integrity; Tooth Fracture
• Intervention / Treatment: Other: Silane coupling agent; Other: Adhesive containing silane.(Intervention 1 ); Other: Acid resistance silane containing adhesive.(Intervention 2)

Detailed Description

some manufacturers have produced silane-containing adhesives in their new products, which might eliminate the need to apply separate silane. However, this silane coupling agent can be hydrolyzed by the acidic monomer in the adhesive making it useless. Acid resistance silane containing adhesive is the update version of the silane containing adhesive which provides a long lasting effective bond between the old and new resin composite restorations

• Study Type: Interventional
• Enrollment (Estimated): 75
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yasmin Talaat, master; Phone Number: 01009925731; Email: yasmin-abdelnabi@dentistry.cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Participants Inclusion:

Patients aging (18-45). Patients with a high level of oral hygiene. Patients with good likelihood of recall availability. - Teeth Inclusion: The restorations were first placed 12 to 24 months ago. Teeth with healthy remaining tooth structure. Posterior restorations with approximately 3mm in size occlusal marginal defect. Asymptomatic teeth before repair.

Exclusion Criteria:

• Participants Exclusion:

Patient with high caries risk Patient with poor periodontal health. Heavy bruxism habits. Pregnant or lactating females.

-Teeth Exclusion: The restorations with large defects The restorations in the third molars Last experience with allergic reactions against any components of the used materials.

Patients receiving orthodontic treatment

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Silane coupling agent(Comparator); In the control group, Silane coupling agent (Porcelain primer) will be applied following the acid etch rinsing and drying step, for 30 seconds and then it will be thoroughly dried using air syringe then universal adhesive with regular silane will be actively applied for 20 seconds and then it will be light cured for 20 seconds and final restoration will be done.	Other: Silane coupling agent; Silane coupling agent (Porcelain primer) will be applied following the acid etch rinsing and drying step, for 30 seconds and then it will be thoroughly dried using air syringe then universal adhesive with regular silane will be actively applied for 20 seconds and then it will be light cured for 20 seconds and final restoration will be done
Active Comparator: .Adhesive containing silane.(Intervention 1 ); Universal adhesive with regular silane will be applied for 20 seconds, air thinned for 10 seconds and then it will be light cured for 20 seconds and final restoration will be done using same resin composite material	Other: Adhesive containing silane.(Intervention 1 ); Universal adhesive with regular silane will be applied for 20 seconds, air thinned for 10 seconds and then it will be light cured for 20 seconds and final restoration will be done using same resin composite material
Active Comparator: Acid resistance silane containing adhesive.(Intervention 2); Acid resistance silane containing adhesive will be applied for 20 seconds, dry with gentle air for 3 seconds, then with stronger air and light cured for 10 seconds and final restoration will be done	Other: Acid resistance silane containing adhesive.(Intervention 2); Acid resistance silane containing adhesive will be applied for 20 seconds, dry with gentle air for 3 seconds, then with stronger air and light cured for 10 seconds and final restoration will be done

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Marginal adaptation	Alpha (A) Restoration adapts closely to the tooth structure; there is no visible crevice Bravo (B) There is a visible crevice, the explorer will penetrate, without dentin exposure. Charlie(C) The explorer penetrates into a crevice in which dentin or the base is exposed.	T0= Baseline 24 hours postoperative. T1= 6 months follow up. T2= 12 months follow up.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anatomical form	Alpha (A)Anatomic form ideal Bravo (B)Restoration is under contoured, without dentin, or base exposure Charlie (C)Restoration is under contoured, with dentin or base exposure; anatomic form is unsatisfactory; restoration needs replacement	T0= Baseline 24 hours postoperative. T1= 6 months follow up. T2= 12 months follow up.
Marginal discoloration	Alpha(A) No marginal discoloration. Bravo(B)Minor marginal discoloration without staining toward the pulp, only visible using a mirror and operating light. Charlie(C) Deep discoloration with staining toward the pulp, visible at a speaking distance of 60 to 100 cm.	T0= Baseline 24 hours postoperative. T1= 6 months follow up. T2= 12 months follow up.
Surface roughness	Alpha(A) As smooth as the surrounding enamel. Bravo(B) Rougher than surrounding enamel; improvement by finishing is feasible Charlie(C) Very rough, could become anti-esthetic and/or retain biofilm; improvement by finishing is not feasible	T0= Baseline 24 hours postoperative. T1= 6 months follow up. T2= 12 months follow up.
Secondary caries	Alpha :No active caries present Charlie: Active caries is present in contact with the restoration	T0= Baseline 24 hours postoperative. T1= 6 months follow up. T2= 12 months follow up.
Postoperative sensitivity	Alpha :No postoperative sensitivity Charlie: Short-term and tolerable postoperative sensitivity	T0= Baseline 24 hours postoperative. T1= 6 months follow up. T2= 12 months follow up

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2024
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: April 26, 2024
• First Submitted That Met QC Criteria: April 29, 2024
• First Posted (Actual): April 30, 2024

Study Record Updates

• Last Update Posted (Actual): April 30, 2024
• Last Update Submitted That Met QC Criteria: April 29, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Silane coupling agent; Adhesive containing silane; Acid resistance silane containing adhesive.; Defective resin composite restoration; Repair of posterior resin composite
• Additional Relevant MeSH Terms: Immune System Diseases; Wounds and Injuries; Stomatognathic Diseases; Tooth Diseases; Tooth Injuries; Hypersensitivity; Tooth Discoloration; Tooth Fractures
• Other Study ID Numbers: Composite repair

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No