Clinical trial NCT06392685: Composite Repair Using Silane Coupling Agent
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
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
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-04-30
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Marginal adaptation
timeFrame: T0= Baseline 24 hours postoperative. T1= 6 months follow up. T2= 12 months follow up.
Secondary outcomes:
measure: Anatomical form
timeFrame: T0= Baseline 24 hours postoperative. T1= 6 months follow up. T2= 12 months follow up.
measure: Marginal discoloration
timeFrame: T0= Baseline 24 hours postoperative. T1= 6 months follow up. T2= 12 months follow up.
measure: Surface roughness
timeFrame: T0= Baseline 24 hours postoperative. T1= 6 months follow up. T2= 12 months follow up.
measure: Secondary caries
timeFrame: T0= Baseline 24 hours postoperative. T1= 6 months follow up. T2= 12 months follow up.
measure: Postoperative sensitivity
timeFrame: T0= Baseline 24 hours postoperative. T1= 6 months follow up. T2= 12 months follow up
Other outcomes:
Locations:
Study officials:
References: