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Completed

NCT Number: NCT07269730

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

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.

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Key information

Conditions

Dental Caries Tooth Demineralization Early Childhood Caries (ECC)

Age range

3 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tri-Service General Hospital

Taipei, Taiwan, 11490

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

oral spray

Other

Calcium-containing oral spray

Primary outcomes

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

    Time frame: Baseline and 2 months after initiation of the intervention.

    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.

Secondary outcomes

  1. Salivary calcium concentration

    Time frame: Baseline and 2 months after initiation of the intervention.

    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.

Other outcomes

  1. Exploratory outcome: plaque microbiome

    Time frame: Baseline and 2 months after initiation of the intervention.

    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).

Sponsors and collaborators

Lead sponsor

Tri-Service General Hospital (TSGH)

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Dec 8, 2025
Registry last updated
Aug 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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