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

Effects of Calcium-Containing Solutions on Fluorescence-Detectable Plaque Area : An Exploratory Clinical Study

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.

Study Overview

• Status: Completed
• Conditions: Early Childhood Caries (ECC); Dental Caries Tooth Demineralization
• Intervention / Treatment: Other: oral spray

Detailed Description

Calcium-containing biomimetic materials have been investigated as adjunctive approaches for managing early enamel demineralization. This exploratory randomized clinical trial evaluated the effects of calcium-containing oral sprays on 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. The primary clinical outcome was fluorescence-detectable plaque-associated area measured by QLF. Secondary outcomes included salivary calcium concentration measured using the arsenazo III colorimetric assay, and exploratory plaque microbiome analysis using 16S rRNA gene sequencing.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taiwan
    • Taipei, Taiwan, Taiwan, 11490
      • Tri-Service General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

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.

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo oral spray; Patient receiving oral sprays containing baseline ingredient solution for more than 2 months.	Other: oral spray; Calcium-containing oral spray
Active Comparator: Formula 2 (Formula 1 plus 225 ppm fluoride) oral spray; 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; Calcium-containing oral spray
Experimental: Formula 1 (Calcium-containing oral spray containing 0.3% calcium lactate, 0.01% dicalcium phosphate); 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; Calcium-containing oral spray

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Salivary calcium concentration	Saliva samples collected during the clinical trial were centrifuged at 3,000 rpm for 10 minutes to obtain the clarified supernatant, which was then diluted tenfold for calcium measurement. Salivary calcium concentration was measured in unstimulated whole saliva using an arsenazo III colorimetric assay.	Baseline and 2 months after initiation of the intervention.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exploratory outcome: plaque microbiome	Exploratory plaque microbiome analysis was performed in three of the 15 participants before and after treatment. Plaque samples were collected using a periodontal probe and stored at -80°C. Bacterial DNA was extracted, and the V3-V4 regions of the 16S rRNA gene were analyzed by 16S rRNA gene sequencing. Taxonomic classification was performed using the SILVA 138 reference database and the Ribosomal Database Project (RDP).	Baseline and 2 months after initiation of the intervention.

Collaborators and Investigators

• Sponsor: Tri-Service General Hospital (TSGH)

Study record dates

Study Major Dates

• Study Start (Actual): June 11, 2023
• Primary Completion (Actual): August 5, 2024
• Study Completion (Actual): November 11, 2025

Study Registration Dates

• First Submitted: November 25, 2025
• First Submitted That Met QC Criteria: November 25, 2025
• First Posted (Actual): December 8, 2025

Study Record Updates

• Last Update Posted (Actual): August 21, 2026
• Last Update Submitted That Met QC Criteria: August 19, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: ECC; Oral spray
• Additional Relevant MeSH Terms: Pharmaceutical Preparations; Dosage Forms; Complex Mixtures; Colloids; Aerosols; Oral Sprays
• Other Study ID Numbers: A202305084; 801GB112200 (Other Grant/Funding Number: Tri-Service General Hospital, Tapiei, Taiwan)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Patients who will be recruited are children under 15 years old, whose privacy should be further protected.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No