Clinical Performance of Three Universal Adhesives in Posterior Restorations

Mansoura University

Status: Enrolling

Conditions: Recurrent Caries

Treatments: Other: Universal adhesives application; Other: universal adhesive with bioactive properties; Other: Fluoride-releasing universal adhesive

Study type: Interventional

Funder types: Other

Identifiers

NCT05696431

A01041022

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 21 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients will have at least 3 posterior teeth with carious lesions of ICDAS score 4, or 5.
• The teeth will have to be vital, without spontaneous pain and/or mobility.
• Patients must have a good oral hygiene.
• Patients with normal and full occlusion.

Exclusion criteria

• High caries risk patients with extremely poor oral hygiene.
• Patients with abutments.
• Patients with heavy bruxism habits and clenching.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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30 participants in 3 patient groups, including a placebo group

Universal adhesive

Placebo Comparator group

Description:

After preparation of three posterior cavities in each patient. The cavities will be randomly divided into three groups according to the type of the adhesive used. This group will receive a universal adhesive as control group.

Treatment:

Other: Universal adhesives application

Fluoride-releasing universal adhesive

Active Comparator group

Description:

After preparation of three posterior cavities in each patient. The cavities will be randomly divided into three groups according to the type of the adhesive used. This group will receive a Fluoride-releasing universal adhesive.

Treatment:

Other: Fluoride-releasing universal adhesive

Universal adhesive with bioactive properties

Active Comparator group

Description:

After preparation of three posterior cavities in each patient. The cavities will be randomly divided into three groups according to the type of the adhesive used.This group will receive a universal adhesive with bioactive properties.

Treatment:

Other: universal adhesive with bioactive properties