Clinical trial Recruiting at 1 site Interventional Ages 15 to 25

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 typeInterventional
Ages15 Years to 25 Years
SexAll
Enrollment18 (estimated)
SponsorAin Shams University
Academic / other
Locations1 site (Cairo, Cairo Governorate)
StatusRecruiting
StartedMarch 27, 2024
Main results expectedJune 2026
Study endsJune 2026
Registry record updatedSeptember 10, 2025
Trial IDNCT07146464 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.