Validate the Effect of Calcium Oral Spray on Early Childhood Caries

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-31

Study Completion Date

2025-11-11

Brief Summary

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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.

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Detailed Description

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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

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Dental Caries Tooth Demineralization Early Childhood Caries (ECC)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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placebo oral spray

formula 1 (0.3% calcium) oral spray

No interventions assigned to this group

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

No interventions assigned to this group

formula 1 (0.3% calcium)

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

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

3 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No