Effects of Calcium-Containing Oral Sprays on Fluorescence-Detectable Plaque Area in Children

NCT07269730 | Completed

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

Brief Summary

This exploratory randomized clinical trial aimed to evaluate the effects of calcium-containing oral sprays on the primary clinical outcome, fluorescence-detectable plaque-associated area measured by quantitative light-induced fluorescence (QLF). Fifteen children were randomly assigned to placebo, Formula 1 (0.3% calcium lactate), or Formula 2 (0.3% calcium lactate plus 225 ppm fluoride) oral sprays for two months. Secondary outcomes included salivary calcium concentration and exploratory plaque microbiome analysis.

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 a microplate 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

PLACEBO COMPARATOR

Patient receiving oral sprays containing baseline ingredient solution for more than 2 months.

Other: oral spray

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

ACTIVE COMPARATOR

Patient receiving oral spays containing 0.3% calcium lactate plus 225 ppm fluoride solution for more than 2 month.

Other: oral spray

formula 1 (0.3% calcium lactate)

EXPERIMENTAL

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

Other: oral spray

Interventions

oral spray OTHER

Calcium-containing oral spray

formula 1 (0.3% calcium lactate); formula 2 (0.3% calcium lactate plus 225 ppm fluoride) oral spray; placebo oral spray

Eligibility Criteria

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

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 (TSGH): lead

Study Sites (1)

Tri-Service General Hospital

Taipei, Taiwan, 11490, Taiwan

Location

MeSH Terms

Interventions

Oral Sprays

Intervention Hierarchy (Ancestors)

Aerosols; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Model Details: Exploratory Clinical Study

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: December 8, 2025
• Study Start: June 11, 2023
• Primary Completion: August 5, 2024
• Study Completion: November 11, 2025
• Last Updated: July 28, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)