drugset / Trial / NCT06749977
P11-4 and Fluoride Varnish for Remineralization of Post-orthodontic Lesions
RandomizedParallel-groupDouble-blindTreatment
Summary
This clinical study aims to compare the remineralizing effects of self-assembling peptide P11-4 (SAP11-4) with fluoride varnish in the treatment of post-orthodontic non-cavitated carious lesions (NCLs). The study uses the QLF camera to assess changes in lesion size, severity, and mineralization, evaluating the effectiveness of SAP11-4 in comparison to fluoride varnish or no treatment. The primary endpoint is the change in QLF parameters, alongside ICDAS scores and Nyvad criteria for clinical evaluation.
Timeline
- Start
- 2020-01-01
- Primary completion
- 2021-01-01
- Completion
- 2023-02-20
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | P11-4 | Peptide | — | — |
| Subject | sodium fluoride | Unknown | — | — |
Indications
No indication recorded.