MedDataX Logo

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

NCT ID: NCT07289932

Last Updated: 2025-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-20

Study Completion Date

2026-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

White spot lesions (WSLs) represent the earliest clinically detectable stage of enamel caries and are a common consequence of fixed orthodontic treatment. These lesions are characterized by increased opacity of enamel due to subsurface demineralization. Conventional fluoride-based strategies can promote surface remineralization but often fail to achieve full penetration into the lesion body, limiting complete enamel repair.

Novel biomimetic approaches, such as self-assembling peptides (SAP P11-4), have been developed to address this limitation. SAP molecules can diffuse into the subsurface lesion and form a three-dimensional scaffold that attracts calcium and phosphate ions from saliva, facilitating de novo hydroxyapatite formation and deeper remineralization. In contrast, tri-calcium phosphate (TCP) varnishes provide bioavailable minerals in combination with fluoride to enhance surface remineralization.

Although both strategies show promising laboratory and clinical results, there is limited evidence directly comparing their clinical performance in patients with orthodontically induced WSLs. This study aims to fill that gap by using a split-mouth, randomized controlled design to compare the effectiveness of Curodont Repair (SAP P11-4) and Clinpro White Varnish (TCP) in young adult patients.

The study will focus on the extent of remineralization as assessed by digital imaging and color analysis, supplemented by changes in lesion size and ICDAS II scoring. Patient satisfaction will also be evaluated to capture subjective outcomes of esthetic improvement. Findings from this study are expected to contribute to evidence-based recommendations for minimally invasive management of WSLs.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

White Spot Lesions

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

"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."
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
"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."

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

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

Group Type EXPERIMENTAL

Curodont Repair (SAP P11-4)

Intervention Type 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."

Clinpro White Varnish (Tri-Calcium Phosphate, TCP)

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

Group Type ACTIVE_COMPARATOR

Clinpro White Varnish (Tri-Calcium Phosphate, TCP)

Intervention Type 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."

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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."

Intervention Type 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."

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are 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
Minimum Eligible Age

15 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ain-Shams University

Cairo, , Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

OPD 22 24 (D)

Identifier Type: -

Identifier Source: org_study_id