Comparing four remineralizing treatments for early white spot lesions
Remineralization Potential of Different Remineralizing Agents on Initial Enamel Caries: Laboratory Evaluations and Two-year Randomized Clinical Trial
This two-year randomized test will try four different remineralizing products to see if they help heal early white spot lesions on permanent teeth in young patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 14 Years to 26 Years |
| Sex | All |
| Sponsor | Mansoura University Academic / other |
| Locations | 1 site (Al Mansurah) |
| Trial ID | NCT07111403 on ClinicalTrials.gov |
What this trial studies
This is a double‑blinded, parallel‑arm randomized clinical trial comparing four remineralizing agents (SAP fluoride plus, 10% nano‑hydroxyapatite, 10% nano‑bioactive glass, and Flour Protector S) for initial enamel caries on buccal or labial surfaces. Eligible participants are young patients with at least one visible lesion scored ICDAS II 1 or 2 and good oral hygiene, recruited at the Faculty of Dentistry, Mansoura University. Each participant will be followed for two years with standardized outcome measures and blinded examiners, using sample size calculations targeting at least 30 patients per group. The trial protocol follows CONSORT guidelines and requires institutional ethics approval before initiation.
Who should consider this trial
Good fit: Ideal candidates are young patients who have at least one visible initial enamel caries (ICDAS II score 1 or 2) on a permanent tooth, good oral hygiene, and no recent fluoride application within three months.
Not a fit: Patients with microcavities or dentinal involvement, enamel hypoplasia, fluorosis, discoloration, recent tetracycline use, or recent fluoride application are unlikely to benefit from these remineralizing treatments.
Why it matters
Potential benefit: If successful, these products could help remineralize early enamel lesions and reduce the need for fillings.
How similar studies have performed: Previous laboratory work and some clinical studies report that fluoride varnishes, nano‑hydroxyapatite, and bioactive glass can promote enamel remineralization, but long‑term head‑to‑head randomized comparisons are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participants should have at least one visible initial enamel caries in the permanent teeth * Only lesions with ICDAS II score of 1 or 2 could be included * The patients must have good oral hygiene Exclusion Criteria: * patients receiving tetracyclines, any other medication known to stain teeth - Patients had fluoride application less than 3 months before the study * Teeth which have microcavities or dentinal involvement due to loss of enamel - Teeth that have discoloration, enamel hypoplasia or fluorosis.
Where this trial is running
Al Mansurah
- Faculty of Dentistry, Mansoura University, Egypt — Al Mansurah, Egypt (Recruiting)
Study contacts
- Principal investigator: Tarek A Arisha, Ass Lecturer — Faculty of Dentistry, Mansoura University, Egypt
- Study coordinator: Tarek A Arisha, Ass Lecturer
- Email: tarekadel@mans.edu.eg
- Phone: 01063912693
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.