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 (a calcium-containing oral spray containing 0.3% calcium lactate, 0.01% dicalcium phosphate, and 0.01% mesoporous bioactive glass), or Formula 2 (The same calcium-containing formulation supplemented with 225 ppm fluoride (0.05% NaF)) 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)

• Fluorescence-detectable plaque-associated area measured by quantitative light-induced fluorescence (QLF)

  Fluorescence-detectable plaque-associated area was assessed using quantitative light-induced fluorescence (QLF). QLF images were obtained before and after the two-month intervention, and the fluorescence-detectable plaque-associated area was quantified as a percentage of the assessed tooth area.

  Baseline and 2 months after initiation of the intervention.

Secondary Outcomes (1)

• Salivary calcium concentration

  Baseline and 2 months after initiation of the intervention.

Other Outcomes (1)

• Exploratory outcome: plaque microbiome

  Baseline and 2 months after initiation of the intervention.

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 (Formula 1 plus 225 ppm fluoride) oral spray

ACTIVE COMPARATOR

Patient receiving oral spays containing the calcium-containing formulation supplemented with 225 ppm fluoride (0.05% NaF) for more than 2 month.

Other: oral spray

Formula 1 (Calcium-containing oral spray containing 0.3% calcium lactate, 0.01% dicalcium phosphate)

EXPERIMENTAL

Patient receiving Calcium-containing oral spray (0.3% calcium lactate, 0.01% dicalcium phosphate, and 0.01% mesoporous bioactive glass) for more than 2 months.

Other: oral spray

Interventions

oral spray OTHER

Calcium-containing oral spray

Formula 1 (Calcium-containing oral spray containing 0.3% calcium lactate, 0.01% dicalcium phosphate); Formula 2 (Formula 1 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: August 21, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)