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 (a calcium-containing oral spray containing 0.3% calcium lactate, 0.01% dicalcium phosphate, and 0.01% mesoporous bioactive glass), or Formula 2 (The same calcium-containing formulation supplemented with 225 ppm fluoride (0.05% NaF)) oral sprays for two months. Secondary outcomes included salivary calcium concentration and exploratory plaque microbiome analysis.
Calcium-containing biomimetic materials have been investigated as adjunctive approaches for managing early enamel demineralization. This exploratory randomized clinical trial evaluated the effects of calcium-containing oral sprays on fluorescence-detectable plaque-associated area measured by quantitative light-induced fluorescence (QLF). Fifteen children were randomly assigned to placebo, Formula 1 (a calcium-containing oral spray containing 0.3% calcium lactate, 0.01% dicalcium phosphate, and 0.01% mesoporous bioactive glass), or Formula 2 (the same calcium-containing formulation supplemented with 225 ppm fluoride (0.05% NaF)) oral sprays for two months. The primary clinical outcome was fluorescence-detectable plaque-associated area measured by QLF. Secondary outcomes included salivary calcium concentration measured using the arsenazo III colorimetric assay, and exploratory plaque microbiome analysis using 16S rRNA gene sequencing.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
15
Calcium-containing oral spray
Tri-Service General Hospital
Taipei, Taiwan, Taiwan
Fluorescence-detectable plaque-associated area measured by quantitative light-induced fluorescence (QLF)
Fluorescence-detectable plaque-associated area was assessed using quantitative light-induced fluorescence (QLF). QLF images were obtained before and after the two-month intervention, and the fluorescence-detectable plaque-associated area was quantified as a percentage of the assessed tooth area.
Time frame: Baseline and 2 months after initiation of the intervention.
Salivary calcium concentration
Saliva samples collected during the clinical trial were centrifuged at 3,000 rpm for 10 minutes to obtain the clarified supernatant, which was then diluted tenfold for calcium measurement. Salivary calcium concentration was measured in unstimulated whole saliva using an arsenazo III colorimetric assay.
Time frame: Baseline and 2 months after initiation of the intervention.
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