Validate the Effect of Calcium Oral Spray on Early Childhood Caries

Tri-Service General Hospital15 enrolled

Overview

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).

Study Type

OBSERVATIONAL

Enrollment

Conditions

Dental Caries Tooth Demineralization Early Childhood Caries (ECC)

Eligibility

Sex: ALLMin age: 3 YearsMax age: 15 Years

Medical Language ↔ Plain English

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

Locations (1)

Tri-Service General Hospital

Taipei, Taiwan, Taiwan

Outcomes

Primary Outcomes

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.

Time frame: Saliva samples will be collected at the time of recruitment and 2 months after the application of the clinical trial.

Secondary Outcomes

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).

Time frame: Plaque samples will be collected at the time of recruitment and 2 months after the application of the clinical trial.

Data from ClinicalTrials.gov

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