Dental Caries Tooth DemineralizationNCT07269730
Effects of Calcium-Containing Oral Sprays on Fluorescence-Detectable Plaque Area in Children
A study testing oral spray in people with Dental Caries Tooth Demineralization and Early Childhood Caries (ECC), run by Tri-Service General Hospital (TSGH) at 1 site in Taiwan.
Trial 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). Read more about this study
- Who is it for?
- Ages 3 to 15 years
- Conditions the study is for
- Dental Caries Tooth Demineralization, Early Childhood Caries (ECC)
- What is being tested?
- oral spray
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteTaiwan
- Study dates
- 11 Jun 2023to 11 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Required participants to have an ICDAS code ≥ 1 and ≤ 3 as determined by a clinician.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- oral spray
- Keywords
- ECC, Oral spray
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral sprayOther
Calcium-containing oral spray
| Study group | Role | What they receive |
|---|---|---|
| Placebo oral spray | Placebo comparator | Patient receiving oral sprays containing baseline ingredient solution for more than 2 months. Receives: 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. Receives: 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. Receives: Other: oral spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 2 months after initiation of the intervention.
Secondary outcomes (1)
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.
Measured: Baseline and 2 months after initiation of the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2025
- Study start11 Jun 2023
- Primary completion5 Aug 2024
- Study completion11 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dental Caries Tooth DemineralizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Exploratory Clinical Study
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tri-Service General Hospital (TSGH)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Da-Yo Yuh, Tri-Service General Hospital (TSGH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07269730
- Sponsor's protocol ID
- A202305084
- Other IDs
- 801GB112200
- Status last verified
- Aug 2026
- First submitted
- 25 Nov 2025
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Patients who will be recruited are children under 15 years old, whose privacy should be further protected.
Publications
Lin ZY, Fu E, Li CH, Chang TH, Yuh DY. Effects of calcium-containing solutions on fluorescence-detectable plaque area and enamel mineral volume: an in vitro and exploratory clinical study. BMC Oral Health. 2026 Sep 15;26(1):1873. doi: 10.1186/s12903-026-09789-z.
PubMed 42816839
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Calcium-Containing Solutions on Fluorescence-Detectable Plaque Area : An Exploratory Clinical Study
- ClinicalTrials.gov ID
- NCT07269730
- Acronym / sponsor ID
- A202305084
- Keywords
- ECC, Oral spray
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Tri-Service General Hospital (TSGH)University, hospital or other
- Study start
- 11 Jun 2023 (actual)
- Primary completion
- 5 Aug 2024 (actual)
- Study completion
- 11 Nov 2025 (actual)
- First posted
- 8 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
- Model description
- Exploratory Clinical Study
| Arm | Type | Receives |
|---|---|---|
| Placebo oral spray | Placebo comparator | Other: oral sprayPatient receiving oral sprays containing baseline ingredient solution for more than 2 months. |
| Formula 2 (Formula 1 plus 225 ppm fluoride) oral spray | Active comparator | Other: oral sprayPatient receiving oral spays containing the calcium-containing formulation supplemented with 225 ppm fluoride (0.05% NaF) for more than 2 month. |
| Formula 1 (Calcium-containing oral spray containing 0.3% calcium lactate, 0.01% dicalcium phosphate) | Experimental | Other: oral sprayPatient receiving Calcium-containing oral spray (0.3% calcium lactate, 0.01% dicalcium phosphate, and 0.01% mesoporous bioactive glass) for more than 2 months. |
Who may qualify
- Ages
- 3 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Required participants to have an ICDAS code ≥ 1 and ≤ 3 as determined by a clinician.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oral sprayCalcium-containing oral spray | Other | 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 |
Primary outcome
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.
1 secondary outcome
Salivary calcium concentration
Time frame: Baseline and 2 months after initiation of the intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Derived from this study: PubMed 42816839Lin ZY, Fu E, Li CH, Chang TH, Yuh DY. Effects of calcium-containing solutions on fluorescence-detectable plaque area and enamel mineral volume: an in vitro and exploratory clinical study. BMC Oral Health. 2026 Sep 15;26(1):1873. doi: 10.1186/s12903-026-09789-z.
- Individual participant dataSharing planned: No. Patients who will be recruited are children under 15 years old, whose privacy should be further protected.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing oral spray in people with Dental Caries Tooth Demineralization and Early Childhood Caries (ECC), run by Tri-Service General Hospital (TSGH) at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fluorescence-detectable plaque-associated area measured by quantitative light-induced fluorescence (QLF) (time frame: Baseline and 2 months after initiation of the intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07269730, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.