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

NCT07289932 | Enrolling By Invitation DMC

• 1 other identifier: OPD 22 24 (D)
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

White Spot Lesions

Keywords

White spot lesions Orthodontic white spot lesions Enamel demineralization Enamel remineralization; P11-4 Curodont Repair Tri-calcium phosphate varnish; Biomimetic remineralization Split-mouth randomized controlled tria

Outcome Measures

Primary Outcomes (1)

• Change in color of white spot lesions

  "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."

  Baseline, 3 months, 6 months, and 9 months

Secondary Outcomes (1)

• Change in lesion size

  Baseline, 3 months, 6 months, and 9 months

Study Arms (2)

Curodont Repair (Self-Assembling Peptide, SAP P11-4)

EXPERIMENTAL

Application of Curodont Repair varnish to eligible white spot lesions on one side of the mouth at baseline and after 3 months.

Other: Curodont Repair (SAP P11-4)

Clinpro White Varnish (Tri-Calcium Phosphate, TCP)

ACTIVE COMPARATOR

Application of Clinpro White Varnish to eligible white spot lesions on the contralateral side of the mouth at baseline and after 3 months.

Other: Clinpro White Varnish (Tri-Calcium Phosphate, TCP)

Interventions

Curodont Repair (SAP P11-4) OTHER

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."

Curodont Repair (Self-Assembling Peptide, SAP P11-4)

Clinpro White Varnish (Tri-Calcium Phosphate, TCP) OTHER

"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."

Clinpro White Varnish (Tri-Calcium Phosphate, TCP)

Eligibility Criteria

• Age: 15 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• \- 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain-Shams University

Cairo, Egypt

Location

MeSH Terms

Interventions

tenocyclidine

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: "This study uses a double-blind split-mouth design. Participants and outcome assessors are blinded to the intervention allocation. The treating clinician cannot be blinded due to product differences in application, but will not be involved in outcome evaluation. Data analysis will be performed with blinded group coding."
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: "This is a split-mouth randomized controlled clinical trial. Each participant will receive the self-assembling peptide varnish (Curodont Repair) on one side of the mouth and the tri-calcium phosphate varnish (Clinpro White Varnish) on the contralateral side, allowing within-patient comparison."

Study Record Dates

• First Submitted: December 5, 2025
• First Posted: December 17, 2025
• Study Start: February 20, 2024
• Primary Completion: November 20, 2024
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 17, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR

Locations

EG (1)