Early Childhood CariesPhase 3NCT02385474
Effectiveness of SDF in Arresting Dental Caries in Preschool Children
A Phase 3 study testing 12% SDF and 38% SDF in people with Early Childhood Caries, run by The University of Hong Kong at 1 site in China.
Trial summary
Background: Tooth decay in children (Early childhood caries, or ECC) is a common childhood disease. Poor dentition significantly affects the nutrition, growth, development and general health of children. 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?
- 12% SDF and 38% SDF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 888 participants
- Where
- 1 siteChina
- Study dates
- Mar 2013to Mar 2016
- Phase
- Phase 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 3 to 4 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The children included in the study should
- aged 3-4 years who have tooth decay and are attending the first year of kindergarten,
- be generally healthy,
- have parental consent, and
- have at least 1 tooth with untreated caries that extends into the dentine.
Who cannot join
- Children who are uncooperative and difficult to manage, have major systemic diseases, or are on long-term medication will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Silver Diamine Fluoride in Arresting Dental Caries in Preschool Children: a Randomized Clinical Trial With Different Periodicity and Concentration.
Background: Tooth decay in children (Early childhood caries, or ECC) is a common childhood disease. Poor dentition significantly affects the nutrition, growth, development and general health of children. Conventional dental care for ECC is neither affordable nor accessible, particularly for the disadvantaged communities. Silver diamine fluoride (SDF) is a safe, cost-effective caries-arresting agent that appears to conform to the World Health Organization's Millennium Goals. SDF is commercially available at 38% and 12%, and topically used yearly or half-yearly to arrest ECC. The SDF regimens used for ECC treatment lack an evidence base. Therefore it is necessary to find the most suitable SDF concentration and application interval to arrest ECC. The purpose of this randomised controlled trial is to compare the efficacy of two commercially available SDF solutions at pre-prepared concentrations of 38% and 12% when applied at yearly or half-yearly intervals over 36 months in arresting caries in primary teeth.
Methods / Design: This double-blinded study has recruited 888 kindergarten children aged 3-4 years with caries. The sample size is sufficient for the appropriate statistical analyses. The children were classified into high and low caries rates and equally allocated into four groups for the caries treatment:
Read more
Group A - semi-annual application of 12% SDF; Group B - annual application of 12% SDF; Group C - semi-annual application of 38% SDF; Group D - annual application of 38% SDF. The children will be followed for 36 months in their kindergartens until they enter primary school. Clinical examinations at 6-month intervals will be conducted to assess whether the caries are arrested. Information on confounding factors, such as oral hygiene habits and the use of other fluoride agents, will be collected through a parental questionnaire at the baseline and follow-ups.
Discussion: This study will help determine the most suitable SDF concentration and application interval to arrest caries in children. Because SDF use for caries arrest is painless, simple, and low-cost, it can be widely recommended and promoted for caries control in young children or those with difficulty accessing and affording conventional dental care. The applicability of the findings and their impact on public health would be immense.
- Conditions
- Early Childhood Caries
- Being tested
- 12% SDF, 38% SDF
- Keywords
- silver diamine fluoride, randomized clinical trial, caries, children, fluoride
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
12% SDFDrug
Also called 12% silver diamine fluoride
12% silver diamine fluoride solution, of which the capability of arresting dental caries is not sure
38% SDFDrug
Also called 38% silver diamine fluoride
38% silver diamine fluoride solution, of which the capability of arresting dental caries is known
| Study group | Role | What they receive |
|---|---|---|
| 38% SDF semi-annual | Experimental | semi-annual application of 38% SDF Receives: Drug: 38% SDF |
| 38% SDF annual | Experimental | annual application of 38% SDF Receives: Drug: 38% SDF |
| 12% SDF semi-annual | Active comparator | semi-annual application of 12% SDF Receives: Drug: 12% SDF |
| 12% SDF annual | Active comparator | annual application of 12% SDF Receives: Drug: 12% SDF |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of the baseline number of soft (active) caries surfaces that become arrested (hardened) at 30-month follow-up
Measured: 30-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 posted11 Mar 2015 (estimated)
- Study startMar 2013
- Primary completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 888 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chun Hung Chu, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02385474
- Sponsor's protocol ID
- HKU765213M
- Status last verified
- May 2016
- First submitted
- 4 Feb 2015
- Last updated
- 13 May 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Braga MM, Mendes FM, De Benedetto MS, Imparato JC. Effect of silver diammine fluoride on incipient caries lesions in erupting permanent first molars: a pilot study. J Dent Child (Chic). 2009 Jan-Apr;76(1):28-33.
PubMed 19341576Chu CH, Fung DS, Lo EC. Dental caries status of preschool children in Hong Kong. Br Dent J. 1999 Dec 11;187(11):616-20; discussion 605. doi: 10.1038/sj.bdj.4800347.
PubMed 16163284Chu CH, Lo EC, Lin HC. Effectiveness of silver diamine fluoride and sodium fluoride varnish in arresting dentin caries in Chinese pre-school children. J Dent Res. 2002 Nov;81(11):767-70. doi: 10.1177/0810767.
PubMed 12407092Lo EC, Chu CH, Lin HC. A community-based caries control program for pre-school children using topical fluorides: 18-month results. J Dent Res. 2001 Dec;80(12):2071-4. doi: 10.1177/00220345010800120901.
PubMed 11808764Duangthip D, Fung MHT, Wong MCM, Chu CH, Lo ECM. Adverse Effects of Silver Diamine Fluoride Treatment among Preschool Children. J Dent Res. 2018 Apr;97(4):395-401. doi: 10.1177/0022034517746678. Epub 2017 Dec 13.
PubMed 29237131Fung MHT, Duangthip D, Wong MCM, Lo ECM, Chu CH. Randomized Clinical Trial of 12% and 38% Silver Diamine Fluoride Treatment. J Dent Res. 2018 Feb;97(2):171-178. doi: 10.1177/0022034517728496. Epub 2017 Aug 28.
PubMed 28846469
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Silver Diamine Fluoride in Arresting Dental Caries in Preschool Children: a Randomized Clinical Trial With Different Periodicity and Concentration.
- ClinicalTrials.gov ID
- NCT02385474
- Acronym / sponsor ID
- HKU765213M
- Conditions
- Early Childhood Caries
- Keywords
- silver diamine fluoride, randomized clinical trial, caries, children, fluoride
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 888 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Mar 2016 (actual)
- First posted
- 11 Mar 2015 (estimated)
- 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: Tooth decay in children (Early childhood caries, or ECC) is a common childhood disease. Poor dentition significantly affects the nutrition, growth, development and general health of children. Conventional dental care for ECC is neither affordable nor accessible, particularly for the disadvantaged communities. Silver diamine fluoride (SDF) is a safe, cost-effective caries-arresting agent that appears to conform to the World Health Organization's Millennium Goals. SDF is commercially available at 38% and 12%, and topically used yearly or half-yearly to arrest ECC. The SDF regimens used for ECC treatment lack an evidence base. Therefore it is necessary to find the most suitable SDF concentration and application interval to arrest ECC. The purpose of this randomised controlled trial is to compare the efficacy of two commercially available SDF solutions at pre-prepared concentrations of 38% and 12% when applied at yearly or half-yearly intervals over 36 months in arresting caries in primary teeth.
Methods / Design: This double-blinded study has recruited 888 kindergarten children aged 3-4 years with caries. The sample size is sufficient for the appropriate statistical analyses. The children were classified into high and low caries rates and equally allocated into four groups for the caries treatment:
Group A - semi-annual application of 12% SDF; Group B - annual application of 12% SDF; Group C - semi-annual application of 38% SDF; Group D - annual application of 38% SDF. The children will be followed for 36 months in their kindergartens until they enter primary school. Clinical examinations at 6-month intervals will be conducted to assess whether the caries are arrested. Information on confounding factors, such as oral hygiene habits and the use of other fluoride agents, will be collected through a parental questionnaire at the baseline and follow-ups.
Discussion: This study will help determine the most suitable SDF concentration and application interval to arrest caries in children. Because SDF use for caries arrest is painless, simple, and low-cost, it can be widely recommended and promoted for caries control in young children or those with difficulty accessing and affording conventional dental care. The applicability of the findings and their impact on public health would be immense.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 38% SDF semi-annual | Experimental | Drug: 38% SDFsemi-annual application of 38% SDF |
| 38% SDF annual | Experimental | Drug: 38% SDFannual application of 38% SDF |
| 12% SDF semi-annual | Active comparator | Drug: 12% SDFsemi-annual application of 12% SDF |
| 12% SDF annual | Active comparator | Drug: 12% SDFannual application of 12% SDF |
Who may qualify
- Ages
- 3 to 4 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- The children included in the study should
- aged 3-4 years who have tooth decay and are attending the first year of kindergarten,
- be generally healthy,
- have parental consent, and
- have at least 1 tooth with untreated caries that extends into the dentine.
Key exclusion criteria (1 listed)
- Children who are uncooperative and difficult to manage, have major systemic diseases, or are on long-term medication will be excluded.
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 |
|---|---|---|
| 12% SDFAlso: 12% silver diamine fluoride12% silver diamine fluoride solution, of which the capability of arresting dental caries is not sure | Drug | 12% SDF annual, 12% SDF semi-annual |
| 38% SDFAlso: 38% silver diamine fluoride38% silver diamine fluoride solution, of which the capability of arresting dental caries is known | Drug | 38% SDF annual, 38% SDF semi-annual |
Primary outcome
change of the baseline number of soft (active) caries surfaces that become arrested (hardened) at 30-month follow-up
Time frame: 30-month follow-up
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 13 May 2016.
- Background: PubMed 19341576Braga MM, Mendes FM, De Benedetto MS, Imparato JC. Effect of silver diammine fluoride on incipient caries lesions in erupting permanent first molars: a pilot study. J Dent Child (Chic). 2009 Jan-Apr;76(1):28-33.
- Background: PubMed 16163284Chu CH, Fung DS, Lo EC. Dental caries status of preschool children in Hong Kong. Br Dent J. 1999 Dec 11;187(11):616-20; discussion 605. doi: 10.1038/sj.bdj.4800347.
- Background: PubMed 12407092Chu CH, Lo EC, Lin HC. Effectiveness of silver diamine fluoride and sodium fluoride varnish in arresting dentin caries in Chinese pre-school children. J Dent Res. 2002 Nov;81(11):767-70. doi: 10.1177/0810767.
- Background: PubMed 11808764Lo EC, Chu CH, Lin HC. A community-based caries control program for pre-school children using topical fluorides: 18-month results. J Dent Res. 2001 Dec;80(12):2071-4. doi: 10.1177/00220345010800120901.
- Derived from this study: PubMed 29237131Duangthip D, Fung MHT, Wong MCM, Chu CH, Lo ECM. Adverse Effects of Silver Diamine Fluoride Treatment among Preschool Children. J Dent Res. 2018 Apr;97(4):395-401. doi: 10.1177/0022034517746678. Epub 2017 Dec 13.
- Derived from this study: PubMed 28846469Fung MHT, Duangthip D, Wong MCM, Lo ECM, Chu CH. Randomized Clinical Trial of 12% and 38% Silver Diamine Fluoride Treatment. J Dent Res. 2018 Feb;97(2):171-178. doi: 10.1177/0022034517728496. Epub 2017 Aug 28.
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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.
Chun Hung Chu principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 12% SDF and 38% SDF in people with Early Childhood Caries, 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 5 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 13 May 2016. 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. 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 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?
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?
change of the baseline number of soft (active) caries surfaces that become arrested (hardened) at 30-month follow-up (time frame: 30-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 NCT02385474, which also lists 6 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 13 May 2016.