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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 (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.

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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 (0.3% calcium lactate), or Formula 2 (0.3% calcium lactate plus 225 ppm fluoride) 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. salivary calcium

    Time frame: Saliva samples will be collected at the time of recruitment and 2 months after the application of the clinical trial.

    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.

Secondary outcomes

  1. Plaque bacterial composition

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

    Three out of 15 participants will be selected for bacterial sampling (pre- and post-treatment). Plaque samples will be collected using a periodontal probe and stored in 1.5 mL tubes containing 500 μL of preservation solution at -80°C.

    Bacterial DNA will be extracted following the manufacturer's instructions using the EasyPure Bacteria Genomic DNA Kit (TransGen Biotech, Cat No. EE161). DNA purity and concentration were verified using a Nanodrop spectrophotometer. The V3 and V4 regions of the 16S rRNA gene will be amplified with primers (CCTACGGRRBGCASCAGKVRVGAAT and GGACTACNVGGGTWTCTAATCC) and the MetaVX Library Preparation Kit. Taxonomic classification will be performed using the Silva 138 reference database and the Ribosomal Database Project (RDP).

Other outcomes

  1. cariogenicity area

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

    In the clinical trial, QLF imaging produced three outputs: (1) an original photograph, (2) a binary image highlighting carious lesions, and (3) a fluorescent image. The QLF-area (%) and its change (ΔQLF-area) were measured and compared.

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
Jul 28, 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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