NCT07269730

Validate the Effect of Calcium Oral Spray on Early Childhood Caries

Validate the Effect of T-spray on ECC in Clinical Trials

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 15 (actual)
• Sponsor: Tri-Service General Hospital · Academic / Other
• Sex: All
• Age: 3 Years – 15 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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).

Conditions

• Dental Caries Tooth Demineralization
• Early Childhood Caries (ECC)

Timeline

• Start date: 2024-01-31
• Primary completion: 2024-08-05
• Completion: 2025-11-11
• First posted: 2025-12-08
• Last updated: 2025-12-08

Locations

1 site across 1 country: Taiwan