drugset / Trial / NCT06749977

P11-4 and Fluoride Varnish for Remineralization of Post-orthodontic Lesions

NCT06749977

Completed 45 enrolled Medical University of Sofia
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

EvaluationDrugModalityDoseRoute
Subject P11-4 Peptide
Subject sodium fluoride Unknown

Indications

No indication recorded.