RecruitingNot Applicable

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

Egypt18 participantsStarted 2024-03-27

Plain-language 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.

Who can participate

Age range

15 Years – 25 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in white spot lesion color using standardized cross-polarized photography and digital color analysis

Timeframe: Baseline, 3 months, 6 months, and 9 months

Trial details

NCT IDNCT07146464

SponsorAin Shams University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06

Contact for this trial

Amany yasser mohamed, B.D.S., M.Sc.

01002229647 amany-mohamed@dent.asu.edu.eg

View on ClinicalTrials.gov More Dental Caries Tooth Demineralization trials