Validate the Effect of Calcium Oral Spray on Early Childhood Caries

NCT07269730 | Completed

• 2 other identifiers: A202305084801GB112200
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dental Caries Tooth Demineralization; Early Childhood Caries (ECC)

Keywords

ECC; Oral spray

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (1)

• Plaque bacterial composition

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

Other Outcomes (1)

• cariogenicity area

  QLF images of maxillary front teeth will be collected at the time of recruitment and 2 months after the clinical trial.

Study Arms (3)

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.

Eligibility Criteria

• Age: 3 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• Required participants to have an ICDAS code ≥ 1 and ≤ 3 as determined by a clinician.

You may not qualify if:

• Patient has received caries removal and restoration.
• Patient has received fluoridation within 3 months.
• The parents do not agree to participate in the study.
• Patient has ICDAS code 4 - code 6

Sponsors & Collaborators

• Tri-Service General Hospital: lead

Study Sites (1)

Tri-Service General Hospital

Taipei, Taiwan, 11490, Taiwan

Location

Biospecimen

Retention: SAMPLES WITH DNA

Dental biofilm

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: December 8, 2025
• Study Start: January 31, 2024
• Primary Completion: August 5, 2024
• Study Completion: November 11, 2025
• Last Updated: December 8, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)