Comparative Evaluation of Class V Restorations

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Secondary Caries; Dental Restoration Failure of Marginal Integrity
• Intervention / Treatment: Procedure: Dental restoration

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Dakahliya
    • Mansoura, Dakahliya, Egypt, 35516
      • Hoda Saleh Ismail

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: a nanohybrid resin composite material with a universal adhesive; Each patient will randomly receive one cervical restoration with one of the tested restorative systems	Procedure: Dental restoration; Each patient will receive a cervical restoration using the corresponding group adhesive and restorative material
Active Comparator: 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	Procedure: Dental restoration; Each patient will receive a cervical restoration using the corresponding group adhesive and restorative material
Placebo Comparator: ion-releasing restorative material with a universal adhesive; Each patient will randomly receive one cervical restoration with one of the tested restorative systems	Procedure: Dental restoration; Each patient will receive a cervical restoration using the corresponding group adhesive and restorative material
Active Comparator: 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	Procedure: Dental restoration; Each patient will receive a cervical restoration using the corresponding group adhesive and restorative material

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Principal Investigator: Hoda S Ismail, Lecturer, Faculty of Dentistry, Mansoura University, Egypt

Study record dates

Study Major Dates

• Study Start (Actual): December 2, 2023
• Primary Completion (Estimated): December 2, 2025
• Study Completion (Estimated): December 15, 2025

Study Registration Dates

• First Submitted: December 2, 2023
• First Submitted That Met QC Criteria: December 2, 2023
• First Posted (Actual): December 11, 2023

Study Record Updates

• Last Update Posted (Actual): June 3, 2025
• Last Update Submitted That Met QC Criteria: June 2, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: A01011023 CD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: Data will be available within 6 Months for 2 years
• IPD Sharing Access Criteria: for anyone
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No