Comparative Evaluation of Class V Restorations

Not Applicable

Recruiting

• Conditions: Dental Restoration Failure of Marginal Integrity; Secondary Caries
• Interventions: Procedure: Dental restoration

• Registration Number: NCT06164418
• Lead Sponsor: Mansoura University

Brief Summary

To evaluate and compare the 2-year clinical performance of Class V restorations using various restorative systems with ion-releasing and non-ion-releasing composites, utilizing fluoride-free and fluoride-releasing universal adhesives for bonding

Detailed Description

The experimental design description adhered to the guidelines provided by the Consolidated Standards of Reporting Trials (CONSORT) statement. The present study is planned as a double-blinded randomized clinical trial, ensuring that both the patients and the examiner are unaware of the treatment allocation. The trial will follow a parallel design. A total of one hundred adult patients, who are seeking dental treatment, will be enrolled in the study. The participants will be recruited from the Operative Department clinic at the Faculty of Dentistry, University of Mansoura. The study will focus on one hundred Class V restorations.

No active advertisement will be used for participant recruitment, and instead, a convenience sample will be formed. Prior to participating in the study, each patient will be required to provide informed consent by signing a consent form. The study is scheduled to be conducted from November 2023 to November 2025. The form and protocol of the study will be approved by Mansoura University's ethics committee before initiation.

To determine the appropriate sample size, previous studies examining the clinical success rate of posterior class V restorations restored with ion-releasing materials were considered. These studies reported a 100% success rate at a two-year follow-up. Based on various parameters, including a significance level of 5%, a test power of 80%, and an equivalence limit of 15%, the sample size was calculated. Considering a potential dropout rate of 20%, a sample size of 100 subjects was determined to be suitable.

Study Timeline

• Status Verified: 2023-12
• Study Start: 2023-12-02
• Study First Submitted: 2023-12-02
• Study First Submitted QC: 2023-12-02
• Last Update Submitted: 2023-12-02
• Study First Posted: 2023-12-11
• Last Update Posted: 2023-12-11
• Primary Completion: 2025-12-02
• Study Completion: 2025-12-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patients with one primary cervical caries on the buccal surface of any of their upper or lower posterior teeth. The cervical lesions must have an enamel margin occlusally and a cervical dentin margin
• Patients must have a good oral hygiene;
• Patients with tooth gives a positive response to testing with an electric pulp tester
• Patients with normal and full occlusion,
• Patients with opposing teeth should be natural with no restorations.

Exclusion Criteria

• High caries risk patients with extremely poor oral hygiene,

• Patients involved in orthodontic treatment or periodontal surgery,
• Patients with periodontally involved teeth (chronic periodontitis)
• Patients with heavy bruxism habits and clenching

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
a nanohybrid resin composite material with a fluoride-releasing universal adhesive	Dental restoration	Each patient will randomly receive one cervical restoration with one of the tested restorative systems
ion-releasing restorative material with a universal adhesive	Dental restoration	Each patient will randomly receive one cervical restoration with one of the tested restorative systems
ion-releasing restorative material with a fluoride-releasing universal adhesive	Dental restoration	Each patient will randomly receive one cervical restoration with one of the tested restorative systems
a nanohybrid resin composite material with a universal adhesive	Dental restoration	Each patient will randomly receive one cervical restoration with one of the tested restorative systems

Primary Outcome Measures

Name	Time	Method
Percentage of aesthetic, functional and biological properties for each group	2 years after restoration	Percentage of aesthetic, functional and biological properties that will be clinically assessed using World Dental Federation parameters for each restorative system group

Trial Locations

Locations (1)

Hoda Saleh Ismail; 🇪🇬 Mansoura, Dakahliya, Egypt