Composite Repair Using Silane Coupling Agent

NCT06392685 | Not Yet Recruiting

• 1 other identifier: Composite repair
• Study Type: interventional
• Target: 75
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Tooth Discoloration; Hypersensitivity; Tooth Fracture; Dental Restoration Failure of Marginal Integrity

Keywords

Silane coupling agent; Adhesive containing silane; Acid resistance silane containing adhesive.; Defective resin composite restoration; Repair of posterior resin composite

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Anatomical form

  T0= Baseline 24 hours postoperative. T1= 6 months follow up. T2= 12 months follow up.

• Marginal discoloration

  T0= Baseline 24 hours postoperative. T1= 6 months follow up. T2= 12 months follow up.

• Surface roughness

  T0= Baseline 24 hours postoperative. T1= 6 months follow up. T2= 12 months follow up.

• Secondary caries

  T0= Baseline 24 hours postoperative. T1= 6 months follow up. T2= 12 months follow up.

• Postoperative sensitivity

  T0= Baseline 24 hours postoperative. T1= 6 months follow up. T2= 12 months follow up

Study Arms (3)

Silane coupling agent(Comparator)

ACTIVE 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

.Adhesive containing silane.(Intervention 1 )

ACTIVE COMPARATOR

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 )

Acid resistance silane containing adhesive.(Intervention 2)

ACTIVE COMPARATOR

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)

Interventions

Silane coupling agent OTHER

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

Silane coupling agent(Comparator)

Adhesive containing silane.(Intervention 1 ) OTHER

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

.Adhesive containing silane.(Intervention 1 )

Acid resistance silane containing adhesive.(Intervention 2) OTHER

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

Acid resistance silane containing adhesive.(Intervention 2)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may not qualify if:

• Patient with high caries risk Patient with poor periodontal health. Heavy bruxism habits. Pregnant or lactating females.
• Patients receiving orthodontic treatment

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Tooth Discoloration; Hypersensitivity; Tooth Fractures

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Immune System Diseases; Tooth Injuries; Wounds and Injuries

Central Study Contacts

Yasmin Talaat, master

CONTACT

01009925731; yasmin-abdelnabi@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 26, 2024
• First Posted: April 30, 2024
• Study Start: July 1, 2024
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2025
• Last Updated: April 30, 2024

Record last verified: 2024-04