Self-assembling peptide versus CPP-ACP to reduce white spot lesions on front teeth
Official title: Evaluation of Self Assembling Peptides Versus Amorphous Calcium Phosphate in the Treatment of White Spot Lesions; Split Mouth Randomized Clinical Trial
Run by Ain Shams University · NCT07146464 · Data updated 2026-11-12
This study will test whether a self-assembling peptide (Curodont Repair) or a CPP‑ACP varnish (MI Varnish) better improves the color and reduces the size of early white spot lesions in people aged 15–25 after orthodontic treatment.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 15 Years to 25 Years |
| Sex | All |
| Enrollment | 18 (estimated) |
| Sponsor | Ain Shams University Academic / other |
| Locations | 1 site (Cairo, Cairo Governorate) |
| Status | Recruiting |
| Started | March 27, 2024 |
| Main results expected | June 2026 |
| Study ends | June 2026 |
| Registry record updated | September 10, 2025 |
| Trial ID | NCT07146464 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are healthy 15–25-year-olds with at least one early (ICDAS 1–2) white spot lesion on each side of the upper or lower anterior region, good oral hygiene, and the ability to attend all study visits.
✕Probably not a fit
Patients with more advanced decay (ICDAS ≥3), enamel hypoplasia, extensive facial restorations, tooth erosion, high caries risk, or a known allergy to milk proteins are unlikely to benefit from these topical remineralization approaches.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a randomized, split‑mouth, double‑blinded clinical comparison performed at Ain Shams University that treats one side of each participant's anterior teeth with a self‑assembling peptide and the other side with a CPP‑ACP varnish. Participants aged 15–25 with at least one ICDAS 1–2 lesion on each side receive professional cleaning, standardized photography, and topical applications following manufacturer instructions. Treatments are applied at baseline and repeated per protocol, with follow-up visits and digital imaging used to track color and size changes over nine months. The split‑mouth design reduces between‑patient variability and the primary outcome is change in lesion color over time.
Why it matters
Potential benefit: If successful, this could visibly improve the appearance of white spot lesions on front teeth and reduce the need for more invasive cosmetic treatments.
How similar studies have gone: Previous smaller studies and case series have reported promising but variable remineralization and esthetic improvements with both SAP P11‑4 and CPP‑ACP, so direct comparisons like this one remain important.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Faculty of Dentistry, Ain Shams University
Cairo, Cairo Governorate, Egypt Recruiting
Study contacts
- Study coordinator: Amany yasser mohamed, B.D.S., M.Sc.
- Email: amany-mohamed@dent.asu.edu.eg
- Phone: 01002229647
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.