Self-assembling peptide versus CPP-ACP to reduce white spot lesions on front teeth

Evaluation of Self Assembling Peptides Versus Amorphous Calcium Phosphate in the Treatment of White Spot Lesions; Split Mouth Randomized Clinical Trial

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

• Phase: NA
• Study type: Interventional
• Enrollment: 18 (estimated)
• Ages: 15 Years to 25 Years
• Sex: All
• Sponsor: Ain Shams University (other)
• Locations: 1 site (Cairo, Cairo Governorate)
• Trial ID: NCT07146464 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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 this trial is running

Cairo, Cairo Governorate

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

Study contacts

• Study coordinator: Amany yasser mohamed, B.D.S., M.Sc.

Conditions: Dental Caries Tooth Demineralization, Post-Orthodontic Esthetic Defects, White Spot Lesions - Enamel Demineralization - Self-Assembling Peptides - Casein Phosphopeptide-Amorphous Calcium Phosphate