drugset / Trial / NCT06051981

White Spot Lesions Treatment in Orthodontic

NCT06051981

Phase 4 Unknown 88 enrolled Riyadh Elm University
RandomizedParallel-groupTriple-blindTreatment

Summary

The study aims to investigate the effectiveness of a new treatment for demineralized white spot lesions (WSLs) after fixed appliance therapy. The trial will consist of four parallel groups: control, Fluoride Varnish (FV), Casein Phosphopeptide-Amorphous Calcium Phosphate (CPP-ACP), and Resin Infiltration (RI) groups. Patients will be recruited from Riyadh Elm University's electronic record system and contacted by phone. They will be given an appointment to visit the dental clinic. A total of 22 patients with WSLs will be selected for the study. Two examiners will perform dental examinations using a dental mirror and a ball-ended probe to code the WSL against the ICDAS system. The level of agreement between the two examiners will be assessed using reliability analysis, with an agreement level of above 80% considered. Buccal WSLs will be defined as those that extend from the center of the buccal to either the mesial or distal surface. WSLs coded 3 or higher will be excluded from further examination and treated accordingly.

Timeline

Start
2023-10
Primary completion
2024-02
Completion
2024-03

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Casein phosphopeptide amorphous calcium phosphate Peptide Topical
Subject ICON® (DMG, Hamburg, Germany) Unknown Topical
Subject sodium fluoride Unknown 5 % Topical

Indications

No indication recorded.