Comparing two treatments for white spot lesions in children
Official title: Clinical Outcome of Resin Infiltration Vs Self-Assembling Peptide (P11-4) in Treating White Spot Lesion - a Randomized Clinical Trial
Run by October 6 University · NCT06708481 · Data updated 2026-11-12
This study tests two different treatments for white spot lesions on kids' teeth to see which one works better for improving their appearance and health.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 7 Years to 14 Years |
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | October 6 University Academic / other |
| Locations | 1 site (Cairo, Giza Governorate) |
| Status | Recruiting |
| Started | August 30, 2024 |
| Main results expected | February 2025 |
| Study ends | February 2025 |
| Registry record updated | November 27, 2024 |
| Trial ID | NCT06708481 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are children aged 7-14 years with at least one non-cavitated white spot lesion on their permanent teeth.
✕Probably not a fit
Patients with periodontal diseases, previous treatments for white spot lesions, or any dental restorations will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial evaluates the effectiveness of two treatment methods for white spot lesions: self-assembling peptide (P11-4) alone or combined with fluoride, and resin infiltration. The study involves children aged 7-14 years with non-cavitated white spot lesions on their permanent teeth. Over a period of six months, the outcomes will be assessed through photographic analysis and clinical examinations to measure aesthetic improvement and tooth remineralization. Patient satisfaction will also be evaluated using a Likert scale.
Why it matters
Potential benefit: If successful, this study could provide effective treatment options for improving the appearance and health of white spot lesions in children.
How similar studies have gone: While there have been studies on similar treatments, this specific comparison of self-assembling peptides and resin infiltration is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age (a range from 7-14 years of age was determined) * Good general health (absence of disease/no handicaps, to ensure oral care at home) * Preserved pulp vitality of the teeth. * Consolidated oral care daily. * Agreement by patient and parents (or guardians) to participate in the study Exclusion Criteria: * Patients with periodontal diseases (periodontal pockets or dental mobility) or radiologically identified pathologies (periapical radiolucency). * Teeth revealing any restorations were excluded from the current study. * Any previous or planned WSL treatment.
Where it's running
-
October 6 University
Cairo, Giza Governorate, Egypt Recruiting
Study contacts
- Study coordinator: Dina El Kharadly, PHD
- Email: dina.yousry.dent@o6u.edu.eg
- Phone: 02 38355276
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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.