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

NCT07289932 · tracked via the Priya Life Science Egypt tracker

Sponsor

Ain Shams University

Phase

Not applicable

Started

2024-02-20

Last updated

2025-12-17

Condition(s) studied

White Spot Lesions

Investigational drug(s) / intervention(s)

Curodont Repair (SAP P11-4)Clinpro White Varnish (Tri-Calcium Phosphate, TCP)

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."

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."

Study 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.

Eligibility

Sex

ALL

Min age

15 Years

Max age

25 Years

Healthy volunteers

Accepted

Inclusion Criteria: \- A minimum of one tooth affected by early carious lesions (ICDAS-II codes 1 or 2) in both sides of the mouth that do not require invasive treatment. * Age 15 years and ≤ 25 years * Size and form of the carious lesions must both be fully visible, and accessible * Willing and able to attend the on-study visits and to observe good oral hygiene throughout the study * Provide written informed consent before participation in the study as subjects were minors, informed consent will provided by the parent and/or legal guardian. * patients not on medication affecting their salivary flow and medically free (ASA class I). Exclusion Criteria: * Evidence of tooth erosion. * any form of fluoride application before the study treatment. * patients with hypoplastic enamel defects, multiple restorations on the facial surfaces. * High caries risk patients

Primary outcome measure(s)

Change in color of white spot lesions — Baseline, 3 months, 6 months, and 9 months
"Change in color and appearance of white spot lesions will be assessed using standardized digital intraoral photography and eLAB color analysis system. The color difference (ΔE) values will be calculated to quantify remineralization."

Trial sites (1)

Facility	City	Region	Status
Ain-Shams University	Cairo	Egypt

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07289932 on ClinicalTrials.gov ↗ ← All trials in Egypt