Clinical Evaluation of Remineralizing Potential of Remineralizing Agents on WSLs Managment

Not Applicable

Recruiting

• Conditions: Initial Dental Caries; White Spot Lesion of Tooth

• Registration Number: NCT07111403
• Lead Sponsor: Mansoura University

Brief Summary

To evaluate and compare the clinical effect of four different remineralizing agents on initial enamel caries after a two years follow up.

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-arm design.A young- age patients , who are seeking dental treatment, will be enrolled in the study. The participants will be recruited from the Operative Department clinic at the Facultyof Dentistry, University of Mansoura. The study will focus on initial enamel caries on buccal or labial surfaces of permenant teeth.rior 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 September 2024 to September 2026. The form and protocol of the study will be approved by Mansoura University's ethics committee before initiation.Sample size calculation was based on mean NYVAD scores between studied groups retrieved from previous research that most similar to our research using G power program version 3.1.9.7 to calculate sample size based on expected difference of 31% ,using 2-tailed test , α error =0.05 and power = 80.0% , the total calculated sample size will be at least 30 in each group with each patient having at least one active lesion.

Study Timeline

• Status Verified: 2024-09
• Study Start: 2024-09-10
• Study First Submitted: 2025-08-01
• Study First Submitted QC: 2025-08-01
• Last Update Submitted: 2025-08-07
• Study First Posted: 2025-08-08
• Last Update Posted: 2025-08-13
• Primary Completion: 2026-09-10
• Study Completion: 2026-09-17

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Participants should have at least one visible initial enamel caries in the permanent teeth
• Only lesions with ICDAS II score of 1 or 2 could be included
• The patients must have good oral hygiene

Exclusion Criteria

• patients receiving tetracyclines, any other medication known to stain teeth - Patients had fluoride application less than 3 months before the study
• Teeth which have microcavities or dentinal involvement due to loss of enamel - Teeth that have discoloration, enamel hypoplasia or fluorosis.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
ICDAS II scores	assessment will be done at baseline and after 3, 6, 12 and 24 months.	Remineralization will be assessed using visual tactile assessment of white spot lesions based on change in ICDAS II scores (reduction from score 2 to 1, or from score 1 to 0).

Secondary Outcome Measures

Name	Time	Method
DIAGNOdent score	assessment will be done at baseline and after 3, 6, 12 and 24 months.	Remineralization will be assessed using The DIAGNOdent score which ranges from 0 to 99 with higher score indicating deeper caries. A decrease in value indicates regression of the carious lesion, whereas an increase indicates progression.

Trial Locations

Locations (1)

Faculty of Dentistry, Mansoura University, Egypt; 🇪🇬 Mansoura, Egypt