Composite Repair Using Silane Coupling Agent

Hypersensitivity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06392685
• Other study ID #: Composite repair
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2024
• Est. completion date: July 2025

Study information

• Verified date: April 2024
• Source: Cairo University
• Contact: Yasmin Talaat, master
• Phone: 01009925731
• Email: yasmin-abdelnabi[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 75
• Est. completion date: July 2025
• Est. primary completion date: July 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Dental Restoration Failure of Marginal Integrity
• Hypersensitivity
• Tooth Discoloration
• Tooth Fracture
• Tooth Fractures

Intervention

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
• 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
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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	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.
Secondary	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