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Evaluation of Self-assembling Peptides Versus Amorphous Calcium Phosphate in the Treatment of White Spot Lesions

NCT07146464 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2025-09-10

No results posted yet for this study

Summary

This clinical trial aims to compare the effectiveness of two remineralizing treatments for white spot lesions (WSLs) on the enamel surfaces of the front teeth. WSLs are early signs of tooth decay, often appearing after orthodontic treatment with braces. These white spots may persist for years and affect the esthetic appearance of teeth.

The study will include male and female patients aged 15 to 25 who have at least one early carious lesion (ICDAS scores 1 or 2) on each side of their upper or lower front teeth. The purpose is to determine which treatment - Self-Assembling Peptides (SAP P11-4, Curodont Repair™) or Casein Phosphopeptide-Amorphous Calcium Phosphate (CPP-ACP, MI Varnish™) - is more effective in improving the color and reducing the size of these lesions.

Researchers will use a split-mouth design, where each patient receives both treatments - one on each side of the mouth. Standardized digital photographs will be taken before and after treatment to assess color changes and lesion size. Patients will also rate their satisfaction with the appearance of their teeth after treatment.

The main questions the study will answer are:

Does SAP P11-4 improve the color of white spot lesions more effectively than CPP-ACP?

Is there a noticeable difference in lesion size reduction between the two treatments?

How satisfied are patients with the outcomes of each treatment?

Participants will be followed up at 3, 6, and 9 months after treatment. The results aim to guide clinicians toward the most effective treatment to improve the appearance of white spot lesions in young patients after orthodontic care.

Conditions

  • Dental Caries Tooth Demineralization
  • Post-Orthodontic Esthetic Defects

Interventions

OTHER

Self-Assembling Peptide P11-4 Self-Assembling Peptide P11-4 is a biomimetic material applied topically to white spot lesions on the enamel. It diffuses into the lesion body and forms a three-dimension

Intervention: Self-Assembling Peptide P11-4 Intervention Description: Self-Assembling Peptide P11-4 (SAP P11-4) is a synthetic peptide designed to mimic natural enamel matrix proteins. It is applied to cleaned, etched enamel surfaces with white spot lesions. The peptide diffuses into the subsurface lesion and self-assembles into a 3D scaffold that promotes nucleation and growth of hydroxyapatite crystals. In this study, it is applied at baseline and re-applied after 3 months. The product used is Curodont™ Repair. Intervention: Casein Phosphopeptide-Amorphous Calcium Phosphate (CPP-ACP) Intervention Description: CPP-ACP is a milk-derived peptide complex that stabilizes calcium and phosphate ions in an amorphous form. When applied to enamel surfaces, it delivers these ions to promote remineralization of white spot lesions. In this study, MI Varnish™ is used as the source of CPP-ACP. The varnish is stirred and applied as a thin, uniform layer to cleaned tooth surfaces at baseline and

Sponsors & Collaborators

  • Ain Shams University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
15 Years
Max Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-27
Primary Completion
2026-06-30
Completion
2026-06-30

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07146464 on ClinicalTrials.gov