Dental Caries in ChildrenPhase 2/3NCT05084001
Silver Diamine Fluoride in Preventing Occlusal Caries in Primary Teeth
A Phase 2/3 study testing silver diamine fluoride, sodium fluoride varnish and tonic water in people with Dental Caries in Children, run by The University of Hong Kong at 1 site in China.
Trial summary
In Hong Kong, approximately half of the kindergarten children have dental caries (tooth decay) and the majority (>90%) of the decayed teeth were left untreated. There is a need to generate clinical evidence for designing an effective dental caries prevention programme for preschool children in Hong Kong. Read more about this study
- Who is it for?
- Ages 2 to 4 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries in Children
- What is being tested?
- silver diamine fluoride, sodium fluoride varnish and tonic water
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 769 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2020to 31 Jul 2023
- Phase
- Phase 2/3
- 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 2 to 4 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- be healthy
- have at least one caries-free (no cavitation) primary molar
Who cannot join
- are uncooperative or refuse examination
- have major systemic disease
- present with either acute pain or infections or have gingival ulceration or stomatitis
- have known sensitivity to fluoride, silver or other heavy-metal ions
- are currently involved in any other research that may impact on the present study
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The University of Hong Kong
Hong Kong
Edward Lo, 852-28590292, edward-lo@hku.hk
About this study
Official title: Effectiveness of Silver Diamine Fluoride in Preventing Occlusal Caries in Primary Teeth of Preschool Children: a 30-month Randomized Clinical Trial
In Hong Kong, approximately half of the kindergarten children have dental caries (tooth decay) and the majority (>90%) of the decayed teeth were left untreated. There is a need to generate clinical evidence for designing an effective dental caries prevention programme for preschool children in Hong Kong. The objective of this study is to compare the effectiveness of 38% silver diamine fluoride (SDF), 5% sodium fluoride (NaF) varnish and placebo control in preventing dentine cavitated caries in primary molars in preschool children when applied semi-annually over 30 months. Around 770 preschool children attending Grade 1 in selected kindergartens will be invited to participate in this clinical trial. Only generally healthy children with written parental consent will be included. At baseline, clinical examination will be conducted in the kindergarten to assess the tooth and oral hygiene status of the included children. After the baseline examination, the children will be randomly assigned to one of the following three study groups and the occlusal (biting) surfaces of their primary molars will receive the corresponding interventions: Group A - semi-annual topical application of 38% SDF; Group B - semi-annual application of 5% NaF varnish; and Group C - semi-annual application of placebo control with tonic water. Clinical examination of the study teeth in the children will be conducted every 6 months after the baseline to assess the outcome of the intervention. The primary outcome is whether cavitated dentine caries lesion is found in the treated occlusal tooth surface. The null hypothesis tested is that there is no difference in the effectiveness of semi-annual application of 38% SDF and that of 5% NaF varnish versus placebo control in preventing dentin occlusal caries in primary molars of preschool children. The results of the proposed study will provide evidence to strengthen or refute the recommendation regarding the use of SDF for preventing occlusal caries in primary molars. The study findings will be valuable for guiding decision-making among dental practitioners and health policymakers on whether SDF should be complemented in a school-based caries prevention program.
- Conditions
- Dental Caries in Children
- Being tested
- silver diamine fluoride, sodium fluoride varnish, tonic water
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
silver diamine fluorideDrug
topical application of the agent on tooth surface
sodium fluoride varnishDrug
topical application of the agent on tooth surface
tonic waterOther
topical application of tonic water on tooth surface
| Study group | Role | What they receive |
|---|---|---|
| 38% SDF (Saforide, Toyo Seiyaku Kasei Co. Ltd., Japan) | Experimental | application of silver diamine fluoride solution on occlusal surface of primary molars Receives: Drug: silver diamine fluoride |
| 5% NaF varnish (Duraphat, Colgate Palmolive, USA) | Active comparator | application of sodium fluoride varnish on occlusal surface of primary molars Receives: Drug: sodium fluoride varnish |
| Tonic water | Placebo comparator | application of tonic water on occlusal surface of primary molars Receives: Other: tonic water |
What is being measured
The primary outcome is the main question the study is designed to answer.
dental caries increment in dmfs index
development of decay into dentine to form cavity
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2021
- Study start1 Mar 2020
- Primary completion31 Jul 2023 (estimated)
- Study completion31 Jul 2023 (estimated)
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 Caries in ChildrenStudies 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 769 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05084001
- Sponsor's protocol ID
- UW20-028
- Status last verified
- Jun 2021
- First submitted
- 8 Jun 2021
- Last updated
- 19 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
He S, Duangthip D, Chu CH, Lo ECM. Topical Fluoride in Preventing Occlusal Caries in Children in a Fluoridated Area: A Randomized Clinical Trial. J Dent Res. 2026 Mar;105(3):323-331. doi: 10.1177/00220345251355260. Epub 2025 Aug 16.
PubMed 40817745Duangthip D, He S, Gao SS, Chu CH, Lo ECM. Effectiveness of Silver Diamine Fluoride for Preventing Occlusal Caries in the Primary Teeth of Preschool Children: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2022 May 23;11(5):e35145. doi: 10.2196/35145.
PubMed 35604758
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Silver Diamine Fluoride in Preventing Occlusal Caries in Primary Teeth of Preschool Children: a 30-month Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05084001
- Acronym / sponsor ID
- UW20-028
- Conditions
- Dental Caries in Children
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 769 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 31 Jul 2023 (estimated)
- Study completion
- 31 Jul 2023 (estimated)
- First posted
- 19 Oct 2021 (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.
In Hong Kong, approximately half of the kindergarten children have dental caries (tooth decay) and the majority (>90%) of the decayed teeth were left untreated. There is a need to generate clinical evidence for designing an effective dental caries prevention programme for preschool children in Hong Kong. The objective of this study is to compare the effectiveness of 38% silver diamine fluoride (SDF), 5% sodium fluoride (NaF) varnish and placebo control in preventing dentine cavitated caries in primary molars in preschool children when applied semi-annually over 30 months. Around 770 preschool children attending Grade 1 in selected kindergartens will be invited to participate in this clinical trial. Only generally healthy children with written parental consent will be included. At baseline, clinical examination will be conducted in the kindergarten to assess the tooth and oral hygiene status of the included children. After the baseline examination, the children will be randomly assigned to one of the following three study groups and the occlusal (biting) surfaces of their primary molars will receive the corresponding interventions: Group A - semi-annual topical application of 38% SDF; Group B - semi-annual application of 5% NaF varnish; and Group C - semi-annual application of placebo control with tonic water. Clinical examination of the study teeth in the children will be conducted every 6 months after the baseline to assess the outcome of the intervention. The primary outcome is whether cavitated dentine caries lesion is found in the treated occlusal tooth surface. The null hypothesis tested is that there is no difference in the effectiveness of semi-annual application of 38% SDF and that of 5% NaF varnish versus placebo control in preventing dentin occlusal caries in primary molars of preschool children. The results of the proposed study will provide evidence to strengthen or refute the recommendation regarding the use of SDF for preventing occlusal caries in primary molars. The study findings will be valuable for guiding decision-making among dental practitioners and health policymakers on whether SDF should be complemented in a school-based caries prevention program.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 38% SDF (Saforide, Toyo Seiyaku Kasei Co. Ltd., Japan) | Experimental | Drug: silver diamine fluorideapplication of silver diamine fluoride solution on occlusal surface of primary molars |
| 5% NaF varnish (Duraphat, Colgate Palmolive, USA) | Active comparator | Drug: sodium fluoride varnishapplication of sodium fluoride varnish on occlusal surface of primary molars |
| Tonic water | Placebo comparator | Other: tonic waterapplication of tonic water on occlusal surface of primary molars |
Who may qualify
- Ages
- 2 to 4 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- be healthy
- have at least one caries-free (no cavitation) primary molar
Key exclusion criteria (5 listed)
- are uncooperative or refuse examination
- have major systemic disease
- present with either acute pain or infections or have gingival ulceration or stomatitis
- have known sensitivity to fluoride, silver or other heavy-metal ions
- are currently involved in any other research that may impact on the present study
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 |
|---|---|---|
| silver diamine fluoridetopical application of the agent on tooth surface | Drug | 38% SDF (Saforide, Toyo Seiyaku Kasei Co. Ltd., Japan) |
| sodium fluoride varnishtopical application of the agent on tooth surface | Drug | 5% NaF varnish (Duraphat, Colgate Palmolive, USA) |
| tonic watertopical application of tonic water on tooth surface | Other | Tonic water |
Primary outcome
dental caries increment in dmfs index
Time frame: 30 months
development of decay into dentine to form cavity
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2021.
- Derived from this study: PubMed 40817745He S, Duangthip D, Chu CH, Lo ECM. Topical Fluoride in Preventing Occlusal Caries in Children in a Fluoridated Area: A Randomized Clinical Trial. J Dent Res. 2026 Mar;105(3):323-331. doi: 10.1177/00220345251355260. Epub 2025 Aug 16.
- Derived from this study: PubMed 35604758Duangthip D, He S, Gao SS, Chu CH, Lo ECM. Effectiveness of Silver Diamine Fluoride for Preventing Occlusal Caries in the Primary Teeth of Preschool Children: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2022 May 23;11(5):e35145. doi: 10.2196/35145.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing silver diamine fluoride, sodium fluoride varnish and tonic water in people with Dental Caries in Children, run by The University of Hong Kong at 1 site in China.
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 2 inclusion and 5 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 19 Oct 2021. 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 China. 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.
What does this combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
dental caries increment in dmfs index (time frame: 30 months). 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 NCT05084001, 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 19 Oct 2021.