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

Recruiting now · Not applicable

Conditions studied: Dental Caries Tooth Demineralization, Post-Orthodontic Esthetic Defects

In brief

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.

Key facts

Study ID: NCT07146464
Run by: Ain Shams University
People needed: 18
Starts: 2024-03-27
Expected to finish: 2026-06-01
Last updated by the study team: 2025-09-10

Who can join

Age: 15 and older, up to 25. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Age between 15 and 25 years
Presence of at least one tooth on each side of the anterior region (from right canine to left canine) affected by early carious lesions (ICDAS II code 1 or 2)
Lesion size and form must be fully visible and accessible
Willing and able to attend all study visits and follow instructions
Good general health and oral hygiene
Not taking any medication that affects salivary flow
Provided written informed consent

You may not qualify if…

Evidence of tooth erosion
Prior fluoride varnish application before study treatment
Hypoplastic enamel defects or multiple restorations on facial surfaces of anterior teeth
High caries risk patients
Known or suspected allergy to milk proteins
Use of medications affecting salivary flow

Where it is running

Faculty of Dentistry, Ain Shams University — Cairo, Cairo Governorate, Egypt (enrolling)

Full record on ClinicalTrials.gov

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