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| ID | Type | Description | Link |
|---|---|---|---|
| 801GB112200 | Other Grant/Funding Number | Tri-Service General Hospital, Tapiei, Taiwan |
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This study aimed to evaluate the effects of calcium-based solutions spraying on teeth to evaluate the reduction of cariogenicity through a randomized clinical trial. In the randomized clinical trial, fifteen children will be assigned to placebo, formula 1 (0.3% calcium), or formula 2 (0.3% calcium plus 225 ppm fluoride) groups of oral sprays for two months. Plaque bacterial composition, salivary calcium levels, and the cariogenicity area before and after the usage of sprays will be evaluated.
Calcium has been proposed as an alternative for promoting remineralization of dental caries. This study aimed to evaluate the effects of calcium-based solutions spraying on teeth to evaluate the reduction of cariogenicity through a randomized clinical trial. In the randomized clinical trial, fifteen children will be assigned to placebo, formula 1 (0.3% calcium), or formula 2 (0.3% calcium plus 225 ppm fluoride) groups of oral sprays for two months. Plaque bacterial composition will be analyzed using 16S rRNA gene sequencing, salivary calcium levels using enzyme-linked immunosorbent assay (ELISA), and the cariogenicity area by quantitative light-induced fluorescence (QLF).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| placebo oral spray | formula 1 (0.3% calcium) oral spray | ||
| formula 2 (0.3% calcium plus 225 ppm fluoride) oral spray | |||
| formula 1 (0.3% calcium) | Patient receiving oral spays containing 0.3% calcium solution for more than 2 month. |
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| Measure | Description | Time Frame |
|---|---|---|
| salivary calcium | Saliva samples collected during the clinical trial will be centrifuged at 3000 rpm for 10 minutes to obtain the clarified supernatant, which will then be diluted tenfold for calcium measurement. Calcium concentration will be determined colorimetrically using arsenazo III in an ELISA reader. The calcium-arsenazo III complex will be measured spectrophotometrically at 652 nm, with absorbance proportional to calcium concentration in the sample. | Saliva samples will be collected at the time of recruitment and 2 months after the application of the clinical trial. |
| Measure | Description | Time Frame |
|---|---|---|
| Plaque bacterial composition | Three out of 15 participants will be selected for bacterial sampling (pre- and post-treatment). Plaque samples will be collected using a periodontal probe and stored in 1.5 mL tubes containing 500 μL of preservation solution at -80°C. Bacterial DNA will be extracted following the manufacturer's instructions using the EasyPure Bacteria Genomic DNA Kit (TransGen Biotech, Cat No. EE161). DNA purity and concentration were verified using a Nanodrop spectrophotometer. The V3 and V4 regions of the 16S rRNA gene will be amplified with primers (CCTACGGRRBGCASCAGKVRVGAAT and GGACTACNVGGGTWTCTAATCC) and the MetaVX Library Preparation Kit. Taxonomic classification will be performed using the Silva 138 reference database and the Ribosomal Database Project (RDP). |
| Measure | Description | Time Frame |
|---|---|---|
| cariogenicity area | In the clinical trial, QLF imaging produced three outputs: (1) an original photograph, (2) a binary image highlighting carious lesions, and (3) a fluorescent image. The QLF-area (%) and its change (ΔQLF-area) were measured and compared. | QLF images of maxillary front teeth will be collected at the time of recruitment and 2 months after the clinical trial. |
Inclusion Criteria:
Required participants to have an ICDAS code ≥ 1 and ≤ 3 as determined by a clinician.
Exclusion Criteria:
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A randomized clinical trial (RCT) will be conducted in a double-blind manner with 15 children presenting with early carious lesions in Tri-Service General Hospital, Taipei, Taiwan. Participants will be randomly assigned to one of three groups: placebo (control) and two formulations of calcium spray.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tri-Service General Hospital | Taipei | Taiwan | 11490 | Taiwan |
Patients who will be recruited are children under 15 years old, whose privacy should be further protected.
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Dental biofilm
| Plaque samples will be collected at the time of recruitment and 2 months after the application of the clinical trial. |