Comparing two treatments for white spot lesions in children
Clinical Outcome of Resin Infiltration Vs Self-Assembling Peptide (P11-4) in Treating White Spot Lesion - a Randomized Clinical Trial
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 |
| Enrollment | 150 (estimated) |
| Ages | 7 Years to 14 Years |
| Sex | All |
| Sponsor | October 6 University Academic / other |
| Locations | 1 site (Cairo, Giza Governorate) |
| Trial ID | NCT06708481 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are children aged 7-14 years with at least one non-cavitated white spot lesion on their permanent teeth.
Not a fit: Patients with periodontal diseases, previous treatments for white spot lesions, or any dental restorations will not benefit from this study.
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 performed: While there have been studies on similar treatments, this specific comparison of self-assembling peptides and resin infiltration is relatively novel.
Eligibility criteria
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 this trial is running
Cairo, Giza Governorate
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.