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ENROLLING BY INVITATION
NCT07289932
NA

"Clinical Evaluation of Self-Assembling Peptides Versus Tri-Calcium Phosphate Based Varnish in Treatment of White Spot Lesions; Split-Mouth Randomized Clinical Trial"

Sponsor: Ain Shams University

View on ClinicalTrials.gov

Summary

Brief Summary: This randomized controlled clinical trial will evaluate the effectiveness of two remineralizing agents in the treatment of white spot lesions (WSLs) in young adults. White spot lesions are early signs of enamel demineralization that commonly develop after orthodontic treatment. The study will compare a self-assembling peptide-based varnish (Curodont Repair, SAP P11-4) with a tri-calcium phosphate-based varnish (Clinpro White Varnish, 3M) using a split-mouth design. A total of patients aged 15-25 years with at least one eligible WSL on each side of the anterior teeth will be enrolled. Each patient will receive Curodont Repair on one side and Clinpro White Varnish on the contralateral side. Treatments will be applied at baseline and repeated after 3 months. Lesions will be evaluated using standardized digital photography, ICDAS II scoring, lesion size measurements, and patient satisfaction questionnaires at baseline, 3, 6, and 9 months. The primary outcome is the change in color of white spot lesions over 9 months. Secondary outcomes include changes in lesion size, ICDAS scores, and patient-reported satisfaction. The study is double-blinded (patients and outcome assessors) and conducted at the Faculty of Dentistry, Ain Shams University.

Key Details

Gender

All

Age Range

15 Years - 25 Years

Study Type

INTERVENTIONAL

Enrollment

38

Start Date

2024-02-20

Completion Date

2026-12

Last Updated

2025-12-17

Healthy Volunteers

Yes

Interventions

OTHER

Curodont Repair (SAP P11-4)

Application of Curodont Repair, a self-assembling peptide (P11-4) varnish designed to penetrate subsurface enamel lesions and promote hydroxyapatite formation. The varnish will be applied to eligible white spot lesions on one side of the anterior teeth at baseline and re-applied after 3 months according to manufacturer's instructions."

OTHER

Clinpro White Varnish (Tri-Calcium Phosphate, TCP)

"Application of Clinpro White Varnish containing tri-calcium phosphate and fluoride, designed to deliver bioavailable calcium, phosphate, and fluoride ions to the enamel surface. The varnish will be applied to eligible white spot lesions on the contralateral side of the anterior teeth at baseline and re-applied after 3 months according to manufacturer's instructions."

Locations (1)

Ain-Shams University

Cairo, Egypt