Dental Caries Tooth Demineralization, Early Childhood Caries (ECC)
Conditions
Keywords
ECC, Oral spray
Brief 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 (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.
Detailed description
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.
Interventions
OTHERoral spray
Calcium-containing oral spray
Sponsors
Tri-Service General Hospital (TSGH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Intervention model description
Exploratory Clinical Study
Eligibility
Sex/Gender
ALL
Age
3 Years to 15 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fluorescence-detectable plaque-associated area measured by quantitative light-induced fluorescence (QLF) | Baseline and 2 months after initiation of the intervention. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Salivary calcium concentration | Baseline and 2 months after initiation of the intervention. | 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. |
Countries
Taiwan
Outcome results
None listed