Comparative Evaluation of Class V Restorations

Dental Restoration Failure of Marginal Integrity Clinical Trial

Official title:

Comparative Evaluation of Class V Restorations: 2-Year Randomized Double-Blind Trial Comparing Ion-Releasing Materials and Resin Composite

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06164418
• Other study ID #: A01011023 CD
• Status: Recruiting
• Phase: N/A
• Start date: December 2, 2023
• Est. completion date: December 15, 2025

Study information

• Verified date: December 2023
• Source: Mansoura University
• Contact: Hoda S Ismail, Lecturer
• Phone: 01553968316
• Email: hoda_saleh[@]mans.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 15, 2025
• Est. primary completion date: December 2, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Dental Restoration Failure of Marginal Integrity
• Secondary Caries

Intervention

Procedure:
• Dental restoration
Each patient will receive a cervical restoration using the corresponding group adhesive and restorative material

Locations

Country	Name	City	State
Egypt	Hoda Saleh Ismail	Mansoura	Dakahliya

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of aesthetic, functional and biological properties for each group	Percentage of aesthetic, functional and biological properties that will be clinically assessed using World Dental Federation parameters for each restorative system group	2 years after restoration