Comparative Evaluation of Class V Restorations

NCT ID: NCT06164418

Last Updated: 2025-06-03

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-02
• Study Completion Date: 2025-12-15

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.

Conditions

Secondary Caries; Dental Restoration Failure of Marginal Integrity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

a nanohybrid resin composite material with a universal adhesive

Each patient will randomly receive one cervical restoration with one of the tested restorative systems

Group Type: PLACEBO_COMPARATOR

Dental restoration

Intervention Type: PROCEDURE

Each patient will receive a cervical restoration using the corresponding group adhesive and restorative material

a nanohybrid resin composite material with a fluoride-releasing universal adhesive

Each patient will randomly receive one cervical restoration with one of the tested restorative systems

Group Type: ACTIVE_COMPARATOR

Dental restoration

Intervention Type: PROCEDURE

Each patient will receive a cervical restoration using the corresponding group adhesive and restorative material

ion-releasing restorative material with a universal adhesive

Each patient will randomly receive one cervical restoration with one of the tested restorative systems

Group Type: PLACEBO_COMPARATOR

Dental restoration

Intervention Type: PROCEDURE

Each patient will receive a cervical restoration using the corresponding group adhesive and restorative material

ion-releasing restorative material with a fluoride-releasing universal adhesive

Each patient will randomly receive one cervical restoration with one of the tested restorative systems

Group Type: ACTIVE_COMPARATOR

Dental restoration

Intervention Type: PROCEDURE

Each patient will receive a cervical restoration using the corresponding group adhesive and restorative material

Interventions

Dental restoration

Each patient will receive a cervical restoration using the corresponding group adhesive and restorative material

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Hoda saleh

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hoda S Ismail, Lecturer

Role: PRINCIPAL_INVESTIGATOR

Faculty of Dentistry, Mansoura University, Egypt

Locations

Hoda Saleh Ismail

Al Mansurah, Dakahliya, Egypt

Countries

Egypt

Other Identifiers

A01011023 CD

Identifier Type: -

Identifier Source: org_study_id