Dental CariesPhase 2NCT04399369
Preventing Caries with Silver Diamine Fluoride
A Phase 2 study testing SDF and NaF in people with Dental Caries, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
Background: Early childhood caries (tooth decay, ECC) affected 55% 5-year-old Hong Kong children, and 70% of these children had gross destruction of the upper anterior teeth with negative long-term impacts on health and quality of life. Read more about this study
- Who is it for?
- Ages 3 to 4 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- SDF and NaF
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 688 participants
- Where
- 1 siteHong Kong
- Study dates
- 22 Oct 2020to 11 Oct 2023
- Phase
- Phase 2
- 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
- Healthy volunteers accepted
- Child
Who may be able to join
- generally healthy, with parental consents
Who cannot join
- uncooperative and difficult to manage, have major systemic diseases such as porphyria, or are on long-term medication such as anti-epileptic drugs.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preventing Early Childhood Caries with Silver Diamine Fluoride - a 12-month Randomised Clinical Trial
Background: Early childhood caries (tooth decay, ECC) affected 55% 5-year-old Hong Kong children, and 70% of these children had gross destruction of the upper anterior teeth with negative long-term impacts on health and quality of life. The existing standard of care for prevention of ECC, topical application of 5% sodium fluoride (NaF) varnish, is inadequate. In Hong Kong and other parts of the world, 38% silver diamine fluoride (SDF) solution, applied topically to cavities, is used to arrest ECC. Work published by our research group suggests it likely also has a preventive effect of ECC. Moreover, SDF has been shown to be preventive in tooth decay in permanent teeth. Nevertheless, no pivotal clinical trial has been performed to support a change in usual practice.
Aim: This is a Phase II single-centre randomized, double-blind, active-controlled, parallel-group pragmatic trial with two arms to assess the effectiveness of 38% SDF and 5% NaF in preventing new caries lesions in primary anterior teeth. Methods: 688 three-year-old kindergarten children who are healthy will be recruited, stratified by school, and block randomized to receive either 38% SDF (treatment group) or 5% NaF (standard treatment group) therapy on primary upper anterior teeth. This sample size is sufficient for a superiority trial with power at 90%, allowing for a 15% dropout rate. The primary outcome is the number of sound tooth surfaces that become cavitated caries per child at 12-month follow-up. The secondary outcome is the number of carious tooth surfaces developed after baseline that become arrested at 12-month for each child. Dental examinations for the status of caries (active or arrested) will be conducted by the same calibrated examiner. The examiner, children and children's parents will be blind to treatment allocation. Parents will be surveyed to study the children's oral health-related behaviours and socioeconomic backgrounds, which will allow the adjustment for effect modification. Possible results and implications: If the results are as anticipated, it will help change the standard of care for caries prevention. If adopted in Hong Kong, SDF therapy will prevent 20,800 (13% of the 160,000) kindergarten children from having caries developed in their anterior teeth, thus reduce significantly the burden of ECC of the children and related stress of their family. Moreover, the results will be widely available and increase adoption of SDF in other countries to reduce the global burden of ECC among children.
- Conditions
- Dental Caries
- Being tested
- SDF, NaF
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SDFDevice
38% silver diamine fluoride solution
NaFDevice
5% sodium fluoride varnish
| Study group | Role | What they receive |
|---|---|---|
| SDF | Experimental | 38% silver diamine fluoride solution Receives: Device: SDF |
| NaF | Active comparator | 5% sodium fluoride varnish Receives: Device: NaF |
What is being measured
The primary outcome is the main question the study is designed to answer.
caries prevention
the number of sound tooth surfaces that become cavitated caries per child
Measured: at 12-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2020
- Study start22 Oct 2020
- Primary completion11 Oct 2023
- Study completion11 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Dental 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 5% NaF and 38% SDF
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 688 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chun Hung Chu, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04399369
- Sponsor's protocol ID
- 20200520
- Status last verified
- Sep 2024
- First submitted
- 19 May 2020
- Last updated
- 25 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Zheng FM, Yan IG, Duangthip D, Lo ECM, Gao SS, Chu CH. Caries Prevention Using Silver Diamine Fluoride: A 12-Month Clinical Trial. Int Dent J. 2023 Oct;73(5):667-673. doi: 10.1016/j.identj.2022.12.005. Epub 2023 Jan 20.
PubMed 36682908Gao SS, Zheng FM, Chen KJ, Duangthip D, Lo ECM, Chu CH. Comparing two fluoride therapies for caries management in young children: study protocol for a randomised clinical trial. Trials. 2021 Aug 4;22(1):519. doi: 10.1186/s13063-021-05496-y.
PubMed 34348775
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Early Childhood Caries with Silver Diamine Fluoride - a 12-month Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT04399369
- Acronym / sponsor ID
- 20200520
- Conditions
- Dental Caries
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 688 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 22 Oct 2020 (actual)
- Primary completion
- 11 Oct 2023 (actual)
- Study completion
- 11 Oct 2023 (actual)
- First posted
- 22 May 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.
Background: Early childhood caries (tooth decay, ECC) affected 55% 5-year-old Hong Kong children, and 70% of these children had gross destruction of the upper anterior teeth with negative long-term impacts on health and quality of life. The existing standard of care for prevention of ECC, topical application of 5% sodium fluoride (NaF) varnish, is inadequate. In Hong Kong and other parts of the world, 38% silver diamine fluoride (SDF) solution, applied topically to cavities, is used to arrest ECC. Work published by our research group suggests it likely also has a preventive effect of ECC. Moreover, SDF has been shown to be preventive in tooth decay in permanent teeth. Nevertheless, no pivotal clinical trial has been performed to support a change in usual practice.
Aim: This is a Phase II single-centre randomized, double-blind, active-controlled, parallel-group pragmatic trial with two arms to assess the effectiveness of 38% SDF and 5% NaF in preventing new caries lesions in primary anterior teeth. Methods: 688 three-year-old kindergarten children who are healthy will be recruited, stratified by school, and block randomized to receive either 38% SDF (treatment group) or 5% NaF (standard treatment group) therapy on primary upper anterior teeth. This sample size is sufficient for a superiority trial with power at 90%, allowing for a 15% dropout rate. The primary outcome is the number of sound tooth surfaces that become cavitated caries per child at 12-month follow-up. The secondary outcome is the number of carious tooth surfaces developed after baseline that become arrested at 12-month for each child. Dental examinations for the status of caries (active or arrested) will be conducted by the same calibrated examiner. The examiner, children and children's parents will be blind to treatment allocation. Parents will be surveyed to study the children's oral health-related behaviours and socioeconomic backgrounds, which will allow the adjustment for effect modification. Possible results and implications: If the results are as anticipated, it will help change the standard of care for caries prevention. If adopted in Hong Kong, SDF therapy will prevent 20,800 (13% of the 160,000) kindergarten children from having caries developed in their anterior teeth, thus reduce significantly the burden of ECC of the children and related stress of their family. Moreover, the results will be widely available and increase adoption of SDF in other countries to reduce the global burden of ECC among children.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- 5% NaF and 38% SDF
| Arm | Type | Receives |
|---|---|---|
| SDF | Experimental | Device: SDF38% silver diamine fluoride solution |
| NaF | Active comparator | Device: NaF5% sodium fluoride varnish |
Who may qualify
- Ages
- 3 to 4 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- generally healthy, with parental consents
Key exclusion criteria (1 listed)
- uncooperative and difficult to manage, have major systemic diseases such as porphyria, or are on long-term medication such as anti-epileptic drugs.
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 |
|---|---|---|
| SDF38% silver diamine fluoride solution | Device | SDF |
| NaF5% sodium fluoride varnish | Device | NaF |
Primary outcome
caries prevention
Time frame: at 12-month follow-up
the number of sound tooth surfaces that become cavitated caries per child
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 25 Sep 2024.
- Derived from this study: PubMed 36682908Zheng FM, Yan IG, Duangthip D, Lo ECM, Gao SS, Chu CH. Caries Prevention Using Silver Diamine Fluoride: A 12-Month Clinical Trial. Int Dent J. 2023 Oct;73(5):667-673. doi: 10.1016/j.identj.2022.12.005. Epub 2023 Jan 20.
- Derived from this study: PubMed 34348775Gao SS, Zheng FM, Chen KJ, Duangthip D, Lo ECM, Chu CH. Comparing two fluoride therapies for caries management in young children: study protocol for a randomised clinical trial. Trials. 2021 Aug 4;22(1):519. doi: 10.1186/s13063-021-05496-y.
- 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 Phase 2 study testing SDF and NaF in people with Dental 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 1 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 25 Sep 2024. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
caries prevention (time frame: at 12-month follow-up). 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 NCT04399369, which also lists 2 linked publications.
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 25 Sep 2024.