A RANDOMIZED CONTROLLED TRIAL COMPARING THE EFFECTIVENESS OF 2.1% AQUEOUS SODIUM FLUORIDE VERSUS 5% SODIUM FLUORIDE VARNISH FOR CARIES PREVENTION IN PRESCHOOL CHILDREN

Faculty of Dentistry, Mahidol University0 个研究点目标入组 240 人开始时间: 2026年7月6日最近更新: 2026年8月3日

适应症

试验速览

暂无简介。

•Subject level
•Generally healthy children classified as ASA (American Society of Anesthesiologists) Physical Status I
•Written informed consent obtained from the parents or legal guardians
•Presence of at least one eligible primary tooth surface with active initial caries at baseline for outcome assessment
•Tooth surfaces level
•Active initial caries lesions (ICDAS 2 - 3) eligible for caries progression assessment
•Sound primary tooth surfaces (ICDAS 0) eligible for caries incidence assessment

•Subject level
•Medical conditions or medications that significantly affect salivary flow or enamel integrity
•Known history of hypersensitivity or allergic reaction to any component of the fluoride products
•Inability to complete the baseline oral examination due to persistent uncooperative behavior
•Parents or primary caregivers who are unable to read and complete the questionnaire
•Tooth surfaces level
•Primary tooth surfaces affected by developmental enamel defects including enamel hypoplasia or fluorosis that may interfere with ICDAS scoring
•Primary teeth with any surface scored as ICDAS 5 - 6 at baseline that requires full-coverage treatment

发起方

Faculty of Dentistry, Mahidol University