Clinical Evaluation of Remineralizing Potential of Remineralizing Agents on WSLs Managment

Mansoura University

Status: Enrolling

Conditions: White Spot Lesion of Tooth; Initial Dental Caries

Treatments: Procedure: 10% n-BAG.; Procedure: Flour Protector S; Procedure: SAP fluoride plus; Procedure: 10% n-HAp.

Study type: Interventional

Funder types: Other

Identifiers

NCT07111403

A0108024CD

Details and patient eligibility

About

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

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 14 to 26 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 4 patient groups

SAP fluoride plus

Active Comparator group

Description:

Participants in this group received P11-4 (Curodont Repair™, Biomedical products for tooth preservation) only at baseline. First, the tooth was completely isolated using rubber dam followed by cleaning of the tooth surface with sodium hypochlorite 2% for 20 s, acid etching with phosphoric acid gel 35-37% for 20 s, rinsing and drying.

Treatment:

Procedure: SAP fluoride plus

10% n-HAp

Active Comparator group

Description:

A Low-speed handpiece was used to clean the tooth surface with fluoride-free pumice (Pumice powder extra fine, SSWhite, Rio de Janeiro, Brazil) after tooth isolation, rinsing, and drying. after that the material was applied

Treatment:

Procedure: 10% n-HAp.

10% n-BAG.

Active Comparator group

Description:

A Low-speed handpiece was used to clean the tooth surface with fluoride-free pumice (Pumice powder extra fine, SSWhite, Rio de Janeiro, Brazil) after tooth isolation, rinsing, and drying. after that the material was applied

Treatment:

Procedure: 10% n-BAG.

Flour Protector S

Active Comparator group

Description:

The teeth were dried and a very thin coat of the varnish was applied and allowed to dry for 20 s.

Treatment:

Procedure: Flour Protector S