Early Childhood CariesPhase 3NCT02019160
Effectiveness of Dental Caries Arrest Treatment in Primary Teeth Using AgNO3 Followed by NaF Varnish
A Phase 3 study testing 25% AgNO3 solution followed by 5% NaF varnish in people with Early Childhood Caries, run by The University of Hong Kong at 1 site in China.
Trial summary
Aim: This randomised controlled trial will systematically compare the efficacy of a 25% AgNO3 solution followed by 5% NaF varnish with that of a 38% SDF solution in arresting caries teeth among preschool children when applied at half-yearly intervals over a 30-month period. Read more about this study
- Who is it for?
- Ages 3 to 5 years
- Conditions the study is for
- Early Childhood Caries
- What is being tested?
- 25% AgNO3 solution followed by 5% NaF varnish
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,070 participants
- Where
- 1 siteChina
- Study dates
- Sep 2014to Jun 2018
- 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 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Kindergarteners who have joined our outreach dental service will be invited to join this study. Preschool children aged 3-4 years who have tooth decay and are attending the first year of kindergarten will be invited to join this study.
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 Biannual Application of Silver Nitrate Solution Followed by Sodium Fluoride Varnish in Arresting Early Childhood Caries in Preschool Children: a 30-month, Randomised, Double-blind, Non-inferiority Trial
- Aim: This randomised controlled trial will systematically compare the efficacy of a 25% AgNO3 solution followed by 5% NaF varnish with that of a 38% SDF solution in arresting caries teeth among preschool children when applied at half-yearly intervals over a 30-month period.
- Method: The extension of the Consolidated Standards of Reporting Trials 2010 Statement will be followed for this 30-month, randomised, double-blinded, non-inferiority clinical trial. Approximately 2,400 kindergarten children will be screened and at least 826 children with caries will be recruited. This sample size is sufficient for an appropriate statistical analysis (power at 90% [β=0.10] with a 2-sided type-I error of α=0.05), allowing for a 18% drop-out rate. The children will be randomly allocated into 2 groups to treat their caries over a 30-month period: Group A - biannual application of a 25% AgNO3 solution followed by a 5% NaF varnish, and Group B - biannual application of a 38% SDF solution followed by a placebo varnish.Clinical examinations will be conducted at 6-month intervals to assess whether the caries are arrested. Information on confounding factors such as oral hygiene habits will be collected through a parental questionnaire.
- Possible results and implications: As the first of its kind, this study would help to determine whether AgNO3 followed by NaF is at least as effective as SDF in arresting childhood caries. If so, because 25% AgNO3 and 5% NaF contain less silver and fluoride, respectively, than 38% SDF, their use would be more favourable than SDF in young children.
- Conditions
- Early Childhood Caries
- Being tested
- 25% AgNO3 solution followed by 5% NaF varnish, 38% SDF solution followed by placebo varnish
- Keywords
- silver nitrate, sodium fluoride, silver diamine fluoride, caries, non-inferiority trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
25% AgNO3 solution followed by 5% NaF varnishDrug
Also called silver nitrate, sodium fluoride
Dosage of 4.4μg±1.4μg fluoride per use
38% SDF solution followed by placebo varnishDrug
Also called silver diamine fluoride
Dosage of 8.8μg±2.8μg fluoride per use
| Study group | Role | What they receive |
|---|---|---|
| Silver nitrate | Experimental | Biannual application of 25% AgNO3 solution followed by 5% NaF varnish. Receives: Drug: 25% AgNO3 solution followed by 5% NaF varnish |
| Silver diamine fluoride | Active comparator | Biannual application of 38% SDF solution followed by placebo varnish. Receives: Drug: 38% SDF solution followed by placebo varnish |
What is being measured
The primary outcome is the main question the study is designed to answer.
The hardness of cavity on tooth by probing
We expect that topical application of 25% AgNO3 solution followed by 5% NaF varnish and of 38% SDF solution can both effectively arrest ECC.
Measured: The follow-up oral examinations will be conducted every 6 months for 30 months totally
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2013 (estimated)
- Study startSep 2014
- Primary completionJun 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)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
- 1,070 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
- Investigators
- Chun Hung Chu, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02019160
- Sponsor's protocol ID
- chuch14
- Status last verified
- Sep 2019
- First submitted
- 11 Dec 2013
- Last updated
- 26 Sep 2019
- 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. Treatment of early childhood caries: a review and case report. Gen Dent. 2000 Mar-Apr;48(2):142-8.
PubMed 11199573Chu 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 12407092Chu CH, Lo EC. A review of sodium fluoride varnish. Gen Dent. 2006 Jul-Aug;54(4):247-53.
PubMed 16903196Gao SS, Duangthip D, Wong MCM, Lo ECM, Chu CH. Randomized Trial of Silver Nitrate with Sodium Fluoride for Caries Arrest. JDR Clin Trans Res. 2019 Apr;4(2):126-134. doi: 10.1177/2380084418818482. Epub 2019 Feb 15.
PubMed 30931709Chu CH, Gao SS, Li SK, Wong MC, Lo EC. The effectiveness of the biannual application of silver nitrate solution followed by sodium fluoride varnish in arresting early childhood caries in preschool children: study protocol for a randomised controlled trial. Trials. 2015 Sep 25;16:426. doi: 10.1186/s13063-015-0960-2.
PubMed 26407698
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Biannual Application of Silver Nitrate Solution Followed by Sodium Fluoride Varnish in Arresting Early Childhood Caries in Preschool Children: a 30-month, Randomised, Double-blind, Non-inferiority Trial
- ClinicalTrials.gov ID
- NCT02019160
- Acronym / sponsor ID
- chuch14
- Conditions
- Early Childhood Caries
- Keywords
- silver nitrate, sodium fluoride, silver diamine fluoride, caries, non-inferiority trial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,070 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 24 Dec 2013 (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.
- Aim: This randomised controlled trial will systematically compare the efficacy of a 25% AgNO3 solution followed by 5% NaF varnish with that of a 38% SDF solution in arresting caries teeth among preschool children when applied at half-yearly intervals over a 30-month period.
- Method: The extension of the Consolidated Standards of Reporting Trials 2010 Statement will be followed for this 30-month, randomised, double-blinded, non-inferiority clinical trial. Approximately 2,400 kindergarten children will be screened and at least 826 children with caries will be recruited. This sample size is sufficient for an appropriate statistical analysis (power at 90% [β=0.10] with a 2-sided type-I error of α=0.05), allowing for a 18% drop-out rate. The children will be randomly allocated into 2 groups to treat their caries over a 30-month period: Group A - biannual application of a 25% AgNO3 solution followed by a 5% NaF varnish, and Group B - biannual application of a 38% SDF solution followed by a placebo varnish.Clinical examinations will be conducted at 6-month intervals to assess whether the caries are arrested. Information on confounding factors such as oral hygiene habits will be collected through a parental questionnaire.
- Possible results and implications: As the first of its kind, this study would help to determine whether AgNO3 followed by NaF is at least as effective as SDF in arresting childhood caries. If so, because 25% AgNO3 and 5% NaF contain less silver and fluoride, respectively, than 38% SDF, their use would be more favourable than SDF in young children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Silver nitrate | Experimental | Drug: 25% AgNO3 solution followed by 5% NaF varnishBiannual application of 25% AgNO3 solution followed by 5% NaF varnish. |
| Silver diamine fluoride | Active comparator | Drug: 38% SDF solution followed by placebo varnishBiannual application of 38% SDF solution followed by placebo varnish. |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Kindergarteners who have joined our outreach dental service will be invited to join this study. Preschool children aged 3-4 years who have tooth decay and are attending the first year of kindergarten will be invited to join this study.
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 |
|---|---|---|
| 25% AgNO3 solution followed by 5% NaF varnishAlso: silver nitrate, sodium fluorideDosage of 4.4μg±1.4μg fluoride per use | Drug | Silver nitrate |
| 38% SDF solution followed by placebo varnishAlso: silver diamine fluorideDosage of 8.8μg±2.8μg fluoride per use | Drug | Silver diamine fluoride |
Primary outcome
The hardness of cavity on tooth by probing
Time frame: The follow-up oral examinations will be conducted every 6 months for 30 months totally
We expect that topical application of 25% AgNO3 solution followed by 5% NaF varnish and of 38% SDF solution can both effectively arrest ECC.
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 26 Sep 2019.
- 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 11199573Chu CH. Treatment of early childhood caries: a review and case report. Gen Dent. 2000 Mar-Apr;48(2):142-8.
- 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 16903196Chu CH, Lo EC. A review of sodium fluoride varnish. Gen Dent. 2006 Jul-Aug;54(4):247-53.
- Derived from this study: PubMed 30931709Gao SS, Duangthip D, Wong MCM, Lo ECM, Chu CH. Randomized Trial of Silver Nitrate with Sodium Fluoride for Caries Arrest. JDR Clin Trans Res. 2019 Apr;4(2):126-134. doi: 10.1177/2380084418818482. Epub 2019 Feb 15.
- Derived from this study: PubMed 26407698Chu CH, Gao SS, Li SK, Wong MC, Lo EC. The effectiveness of the biannual application of silver nitrate solution followed by sodium fluoride varnish in arresting early childhood caries in preschool children: study protocol for a randomised controlled trial. Trials. 2015 Sep 25;16:426. doi: 10.1186/s13063-015-0960-2.
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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 25% AgNO3 solution followed by 5% NaF varnish 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 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 26 Sep 2019. 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?
The hardness of cavity on tooth by probing (time frame: The follow-up oral examinations will be conducted every 6 months for 30 months totally). 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 NCT02019160, which also lists 7 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 26 Sep 2019.