NCT05696431

Clinical Performance of Three Universal Adhesives in Posterior Restorations

Comparative Evaluation of Two-Year Clinical Performance of Three Universal Adhesives in Posterior Restorations

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Mansoura University · Academic / Other
• Sex: All
• Age: 21 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This study was designed to evaluate and compare the two-year clinical performance of three universal adhesives in posterior composite restorations, based on International dental federation (FDI) criteria.

Detailed description

The description of the experimental design will follow the Consolidated Standards of Reporting Trials (CONSORT) statement. The present study will be a double blinded (patients and examiner) randomized clinical trial anticipating the split-mouth design. 30 adult patients seeking dental treatment in Operative Department clinic at Faculty of Dentistry, Mansoura University will be enrolled in the current study with a total of 90 teeth with Class I or II posterior composite restorations. No advertisement will be made for participant recruitment, forming a sample of convenience. Each patient will sign a consent form before participating in the current study. The study will be conducted from November 2022 to November 2024 as a part of Doctoral dissertation. Mansoura University institution's ethics committee approved the form and protocol before conducting the study. The sample size was calculated based on a previous study with a similar study design. Parameters including a significance level of 5% (p \< 0.05) and a power of 80% were used to calculate an appropriate sample size of 28 cases. Allowing for a 20% drop-out rate, the total sample size was set at 30 cases.

Conditions

• Recurrent Caries

Interventions

Type	Name	Description
OTHER	Universal adhesives application	The adhesive will be used according to their manufacturer's instructions. Selective etching for enamel will be applied for 15 seconds, followed by rinsing and gentle air drying. Then, the adhesive will be applied to enamel and dentin and light cured using a light-curing unit for 20 seconds. The composite material will be incrementally applied, and each increment will be light cured for 20 seconds. The restoration will be finished and polished using finishing and polishing instruments.
OTHER	universal adhesive with bioactive properties	The adhesive will be used according to their manufacturer's instructions. Enamel and dentin will be cleaned using clean and boost for 10 seconds, rinsed and gently dried. Then, the adhesive will be applied to enamel and dentin and light cured using a light-curing unit for 20 seconds. The composite material will be incrementally applied, and each increment will be light cured for 20 seconds. The restoration will be finished and polished using finishing and polishing instruments.
OTHER	Fluoride-releasing universal adhesive	Fluoride-releasing universal adhesive

Timeline

• Start date: 2022-11-05
• Primary completion: 2024-11-05
• Completion: 2024-11-05
• First posted: 2023-01-25
• Last updated: 2023-01-25

Locations

1 site across 1 country: Egypt