Early Childhood CariesNCT04274569
Effect of Three Types of Fluoride Varnish in Preventing Early Childhood Caries
A study testing NaF vanish, NaF-TCP and NaF-CPP-ACP in people with Early Childhood Caries, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
This study evaluates and compares the effect of two types of calcium- and phosphate-containing fluoride varnishes to conventional fluoride varnishes in preventing early childhood caries. Read more about this study
- Who is it for?
- Ages 3 to 4 years
- Conditions the study is for
- Early Childhood Caries
- What is being tested?
- NaF vanish, NaF-TCP and NaF-CPP-ACP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 570 participants
- Where
- 1 siteHong Kong
- Study dates
- 13 Mar 2019to 1 Oct 2022
- 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 4 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Generally healthy children age between 3-4 of age with unremarkable medical history and at high caries risk with at least one carious lesion (precavitated or cavitated) (Agouropoulos et al 2014). The high caries risk children are chosen because it is anticipated that they will benefit more from the topical fluoride varnish application than the low caries risk children.
Who cannot join
- Patients who had received professional fluoride application in the past 6 months
- Patients with underlying medical history or special health care needs
- Patient who are uncooperative or refuse the treatment
- Patient who are allergic to milk protein (as MI VarnishTM contains "casein, a milk protein)
- Patient with contraindication for fluoride varnish e.g. hypersensitivity to colophony and/or any other constituents
- Patient who have primary teeth with enamel hypoplasia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Are Calcium- and Phosphate-containing Fluoride Varnishes More Effective Than Conventional Fluoride Varnish in Preventing Early Childhood Caries? A Randomized Clinical Trial.
This study evaluates and compares the effect of two types of calcium- and phosphate-containing fluoride varnishes to conventional fluoride varnishes in preventing early childhood caries.
Read the detailed description
Fluoride vanish is the most commonly used professionally applied topical agent. Traditional fluoride vanish application has been reported to exhibit significant caries inhibiting effect in both permanent teeth and primary teeth. The greatest advantage of fluoride vanish is its ability to adhere to tooth tissues for a longer period of time that enables improved fluoride uptake. It allows continuous release of fluoride ions into enamel, dentine, plaque, and saliva.The main action of topical fluoride is to retard demineralization and promote remineralization of enamel by the uptake of calcium and phosphates from saliva. The proposed mechanism of action of topical fluoride is the formation of intraoral calcium fluoride reservoirs, which are retained on enamel and slowly released to inhibit mineral loss during demineralization.
However, the formation of the intraoral calcium fluoride reservoirs is limited by the availability of intraoral calcium and fluoride ions. Low concentration of salivary calcium and phosphate ions leads to mineral deposition only at the surface of enamel as a result of low ion concentration gradient. Deposition of minerals at the surface of enamel alone may not improve the structural properties of the deep part of the incipient carious lesions. Hence, many manufacturers have modified fluoride vanish to include calcium and phosphate ions in an attempt to further improve efficacy of fluoride varnishes.
The in vitro remineralizing effects of calcium- and phosphate-containing fluoride vanishes are encouraging and scientifically sound, a longitudinal, high quality clinical study is needed to verify the laboratory findings.
- Conditions
- Early Childhood Caries
- Being tested
- NaF vanish, NaF-TCP, NaF-CPP-ACP
- Keywords
- Caries, Fluoride vanish, Calcium phosphate, Randomised clinical trial, Remineralisation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaF vanishOther
A disposable micro-brush will be used to apply the varnishes to all tooth surfaces. The fluoride varnish will be applied every 3 months, from baseline to 24-months follow-up.
NaF-TCPOther
A disposable micro-brush will be used to apply the varnishes to all tooth surfaces. The fluoride varnish will be applied every 3 months, from baseline to 24-months follow-up.
NaF-CPP-ACPOther
A disposable micro-brush will be used to apply the varnishes to all tooth surfaces. The fluoride varnish will be applied every 3 months, from baseline to 24-months follow-up.
| Study group | Role | What they receive |
|---|---|---|
| Sodium fluoride (NaF) | Active comparator | Group 1: Quarterly application of a 5% NaF varnish (Duraphat® Varnish, Colgate-Palmolive Ltd, (UK) Ltd., Guildford, Surrey, UK) Receives: Other: NaF vanish |
| NaF plus tricalcium phosphate (TCP ) | Experimental | Group 2: Quarterly application of 5% NaF-TCP (ClinproTM White Varnish; 3M ESPE, St Paul, MN, USA) Receives: Other: NaF-TCP |
| NaF plus CPP-ACP | Experimental | Group 3: Quarterly application of a 5% NaF plus casein phosphopeptide-stabilized amorphous calcium phosphate complexes (CPP-ACP) (MI Varnish TM; GC corporation, Itabashi-Ku, Tokyo, Japan) Receives: Other: NaF-CPP-ACP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of children with new caries and new dmfs.
Measured: 24 months
Secondary outcomes (1)
MS growth
Quantity of mutans streptococcus (MS) measured by quantitative polymerase chain reaction (qPCR)
Measured: 12 months and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2020
- Study start13 Mar 2019
- Primary completion15 Jul 2021 (estimated)
- Study completion1 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Childhood CariesStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 570 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Research Grants Council, Hong Kong
- Responsible party
- Principal investigator, Professor Cynthia Kar-Yung Yiu, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04274569
- Sponsor's protocol ID
- GRF Project HKU17106318
- Status last verified
- Feb 2020
- First submitted
- 12 Nov 2019
- Last updated
- 18 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Are Calcium- and Phosphate-containing Fluoride Varnishes More Effective Than Conventional Fluoride Varnish in Preventing Early Childhood Caries? A Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT04274569
- Acronym / sponsor ID
- GRF Project HKU17106318
- Conditions
- Early Childhood Caries
- Keywords
- Caries, Fluoride vanish, Calcium phosphate, Randomised clinical trial, Remineralisation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 570 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Research Grants Council, Hong Kong
- Study start
- 13 Mar 2019 (actual)
- Primary completion
- 15 Jul 2021 (estimated)
- Study completion
- 1 Oct 2022 (estimated)
- First posted
- 18 Feb 2020 (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 study evaluates and compares the effect of two types of calcium- and phosphate-containing fluoride varnishes to conventional fluoride varnishes in preventing early childhood caries.
Detailed description
Fluoride vanish is the most commonly used professionally applied topical agent. Traditional fluoride vanish application has been reported to exhibit significant caries inhibiting effect in both permanent teeth and primary teeth. The greatest advantage of fluoride vanish is its ability to adhere to tooth tissues for a longer period of time that enables improved fluoride uptake. It allows continuous release of fluoride ions into enamel, dentine, plaque, and saliva.The main action of topical fluoride is to retard demineralization and promote remineralization of enamel by the uptake of calcium and phosphates from saliva. The proposed mechanism of action of topical fluoride is the formation of intraoral calcium fluoride reservoirs, which are retained on enamel and slowly released to inhibit mineral loss during demineralization.
However, the formation of the intraoral calcium fluoride reservoirs is limited by the availability of intraoral calcium and fluoride ions. Low concentration of salivary calcium and phosphate ions leads to mineral deposition only at the surface of enamel as a result of low ion concentration gradient. Deposition of minerals at the surface of enamel alone may not improve the structural properties of the deep part of the incipient carious lesions. Hence, many manufacturers have modified fluoride vanish to include calcium and phosphate ions in an attempt to further improve efficacy of fluoride varnishes.
The in vitro remineralizing effects of calcium- and phosphate-containing fluoride vanishes are encouraging and scientifically sound, a longitudinal, high quality clinical study is needed to verify the laboratory findings.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sodium fluoride (NaF) | Active comparator | Other: NaF vanishGroup 1: Quarterly application of a 5% NaF varnish (Duraphat® Varnish, Colgate-Palmolive Ltd, (UK) Ltd., Guildford, Surrey, UK) |
| NaF plus tricalcium phosphate (TCP ) | Experimental | Other: NaF-TCPGroup 2: Quarterly application of 5% NaF-TCP (ClinproTM White Varnish; 3M ESPE, St Paul, MN, USA) |
| NaF plus CPP-ACP | Experimental | Other: NaF-CPP-ACPGroup 3: Quarterly application of a 5% NaF plus casein phosphopeptide-stabilized amorphous calcium phosphate complexes (CPP-ACP) (MI Varnish TM; GC corporation, Itabashi-Ku, Tokyo, Japan) |
Who may qualify
- Ages
- 3 to 4 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Generally healthy children age between 3-4 of age with unremarkable medical history and at high caries risk with at least one carious lesion (precavitated or cavitated) (Agouropoulos et al 2014). The high caries risk children are chosen because it is anticipated that they will benefit more from the topical fluoride varnish application than the low caries risk children.
Key exclusion criteria (6 listed)
- Patients who had received professional fluoride application in the past 6 months
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 |
|---|---|---|
| NaF vanishA disposable micro-brush will be used to apply the varnishes to all tooth surfaces. The fluoride varnish will be applied every 3 months, from baseline to 24-months follow-up. | Other | Sodium fluoride (NaF) |
| NaF-TCPA disposable micro-brush will be used to apply the varnishes to all tooth surfaces. The fluoride varnish will be applied every 3 months, from baseline to 24-months follow-up. | Other | NaF plus tricalcium phosphate (TCP ) |
| NaF-CPP-ACPA disposable micro-brush will be used to apply the varnishes to all tooth surfaces. The fluoride varnish will be applied every 3 months, from baseline to 24-months follow-up. | Other | NaF plus CPP-ACP |
Primary outcome
Proportion of children with new caries and new dmfs.
Time frame: 24 months
1 secondary outcome
MS growth
Time frame: 12 months and 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2020.
- Individual participant dataSharing planned: No
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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 NaF vanish, NaF-TCP and NaF-CPP-ACP in people with Early Childhood Caries, run by The University of Hong Kong at 1 site in Hong Kong.
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 6 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: status not confirmed, as of the sponsor's last update on 18 Feb 2020. 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 Hong Kong. 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. 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?
Results are not available in the source record.
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?
Proportion of children with new caries and new dmfs. (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Feb 2020.