Validate the Effect of Calcium Oral Spray on Early Childhood Caries

Tri-Service General Hospital

Status: Completed

Conditions: Early Childhood Caries (ECC); Dental Caries Tooth Demineralization

Study type: Observational

Funder types: Other

Identifiers

NCT07269730

A202305084

801GB112200 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 15 patients

Sex: All

Ages: 3 to 15 years old

Volunteers: No Healthy Volunteers

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

Trial design

15 participants in 3 patient groups

placebo oral spray

Description:

formula 1 (0.3% calcium) oral spray

formula 2 (0.3% calcium plus 225 ppm fluoride) oral spray

formula 1 (0.3% calcium)

Description:

Patient receiving oral spays containing 0.3% calcium solution for more than 2 month.