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S-PRG Filler for Preventing White Spot Lesions During Orthodontic Treatment

Study acronym: SPRG-WSL
StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
White spot lesions are early areas of enamel demineralization that may develop during orthodontic treatment with fixed braces. This study aims to evaluate the effectiveness of S-PRG Barrier Coat in preventing white spot lesions during orthodontic treatment. The study will compare S-PRG Barrier Coat with 5% sodium fluoride varnish, a combination of S-PRG Barrier Coat and 5% sodium fluoride varnish, and a placebo. A total of 144 participants undergoing orthodontic treatment will be randomly assigned to one of four treatment groups. The occurrence and severity of white spot lesions will be assessed using clinical examinations, including the ICDAS-II and Gorelick index, together with DIAGNOdent readings where applicable. The study findings may help determine whether S-PRG Barrier Coat provides an effective preventive approach against orthodontic white spot lesions.
Trial Details
NCT Number NCT07839780
Lead Sponsor National University of Malaysia
Conditions
(from sponsor)		 White Spot Lesion of Tooth, Orthodontic Treatment, Enamel Demineralization, Fluoride Varnishes
Enrollment 144 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov