Clinical Trial

Effects of Calcium-Containing Oral Sprays on Fluorescence-Detectable Plaque Area in Children

Completed
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Summary
This exploratory randomized clinical trial aimed to evaluate the effects of calcium-containing oral sprays on the primary clinical outcome, fluorescence-detectable plaque-associated area measured by quantitative light-induced fluorescence (QLF). Fifteen children were randomly assigned to placebo, Formula 1 (0.3% calcium lactate), or Formula 2 (0.3% calcium lactate plus 225 ppm fluoride) oral sprays for two months. Secondary outcomes included salivary calcium concentration and exploratory plaque microbiome analysis.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-11-25; most recent amendment 2026-07-24.
Trial Details
NCT Number NCT07269730
Lead Sponsor Tri-Service General Hospital (TSGH)
Conditions Dental Caries Tooth Demineralization, Early Childhood Caries (ECC)
Enrollment 15 participants
Start Date 2023-06-11
Primary Completion 2024-08-05 (estimated)
Study Completion 2025-11-11 (estimated)
Updated on ClinicalTrials.gov 2026-07-28