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Completed
NCT07269730
Validate the Effect of Calcium Oral Spray on Early Childhood Caries
Conditions: Dental Caries Tooth Demineralization, Early Childhood Caries (ECC)
Sex: All
Ages: 3 Years – 15 Years
Healthy volunteers: No
Enrollment: 15
Sponsor: Tri-Service General Hospital (TSGH)
Location: Tri-Service General Hospital Taipei Taiwan
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.
Eligibility Criteria
Inclusion Criteria:
Required participants to have an ICDAS code ≥ 1 and ≤ 3 as determined by a clinician.
Exclusion Criteria:
1. Patient has received caries removal and restoration.
2. Patient has received fluoridation within 3 months.
3. The parents do not agree to participate in the study.
4. Patient has ICDAS code 4 - code 6
Source: ClinicalTrials.gov (NCT07269730). StuddyBuddy aggregates publicly available trial information.
