Early Childhood CariesPhase 3NCT03423797
The Caries-arresting Effect of Incorporating fTCP to NaF Varnish Applied Following AgNO3 in Preschool Children
A Phase 3 study testing 25% AgNO3 solution followed by 5% NaF and 25% AgNO3 solution followed by 5% NaF with fTCP in people with Early Childhood Caries, run by The University of Hong Kong at 1 site in China.
Trial summary
The objective of this study is to compare the effectiveness of 25% AgNO3 solution plus 5% NaF varnish and 25% AgNO3 solution plus 5% NaF varnish with fTCP when applied semi-annually over 30 months in arresting dentine caries of primary teeth among preschool children. 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 and 25% AgNO3 solution followed by 5% NaF with fTCP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 408 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2017to 30 Aug 2020
- 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
- have at least one tooth with cavitated dentine carious lesion
Who cannot join
- Children have severe forms of dental hypoplasia, under dental treatment or wearing orthodontic devices, have major systemic illness, and are on long-term medication.
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 With or Without Functionalized Tricalcium Phosphate in Arresting Caries in Preschool Children
The objective of this study is to compare the effectiveness of 25% AgNO3 solution plus 5% NaF varnish and 25% AgNO3 solution plus 5% NaF varnish with fTCP when applied semi-annually over 30 months in arresting dentine caries of primary teeth among preschool children. Half of Participants will receive topical application of 25% AgNO3 solution and 5% NaF varnish, while the other half will receive topical application of 25% AgNO3 solution and 5% NaF varnish with fTCP.
Read the detailed description
Aim:The objective of this study is to compare the effectiveness of commercially available of 25% AgNO3 solution plus 5% NaF varnish and 25% AgNO3 solution plus 5% NaF varnish with fTCP when applied semi-annually over 30 months in arresting dentine caries of primary teeth among preschool children.
Methods: The extension of the Consolidated Standards of Reporting Trials 2010 Statement will be followed for this 30-month, randomised, double-blinded, equivalence clinical trial. Approximately 2,000 kindergarten children will be screened and at least 376 children with caries will be recruited. This sample size is sufficient for an appropriate statistical analysis. 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 25% AgNO3 solution followed by a 5% NaF varnish with functionalized tricalcium phosphate (fTCP).Clinical examinations will be conducted at 6-month intervals to assess whether the caries are arrested (primary outcome). 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 5% NaF varnish with and without fTCP are equivalent in arresting dentine caries of primary teeth in preschool children when applied semi-annually.
- Conditions
- Early Childhood Caries
- Being tested
- 25% AgNO3 solution followed by 5% NaF, 25% AgNO3 solution followed by 5% NaF with fTCP
- Keywords
- silver nitrate, sodium fluoride, dental caries, equivalence trial
- Medical subject headings
- Dental Caries
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% NaFDrug
Also called 5% NaF without fTCP
Dosage: 25% AgNO3 solution 7.9mg(Ag+)/0.05ml (max dose), 5% NaF: 11.6mg (F-)/0.5ml (max dose).
25% AgNO3 solution followed by 5% NaF with fTCPDrug
Also called 5% NaF with fTCP
Dosage: 25% AgNO3 solution 7.9mg(Ag+)/0.05ml (max dose), 5% NaF with fTCP: 11.6mg (F-)/0.5ml (max dose).
| Study group | Role | What they receive |
|---|---|---|
| NaF without fTCP | Active comparator | 25% AgNO3 solution followed by 5% NaF. Receives: Drug: 25% AgNO3 solution followed by 5% NaF |
| NaF with fTCP | Experimental | 25% AgNO3 solution followed by 5% NaF with fTCP. Receives: Drug: 25% AgNO3 solution followed by 5% NaF with fTCP |
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
The effectiveness of adjunctive application of 25% AgNO3 solution and 5% NaF varnish with or without fTCP is expected to be equivalent in arresting dentine caries of primary teeth.
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 posted6 Feb 2018
- Study start1 Sep 2017
- Primary completion1 May 2020
- Study completion30 Aug 2020
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 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
- 408 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, Ph.D, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03423797
- Sponsor's protocol ID
- UW 17-176
- Status last verified
- Nov 2020
- First submitted
- 31 Jan 2018
- Last updated
- 4 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chen KJ, Gao SS, Duangthip D, Lo ECM, Chu CH. Randomized Clinical Trial on Sodium Fluoride with Tricalcium Phosphate. J Dent Res. 2021 Jan;100(1):66-73. doi: 10.1177/0022034520952031. Epub 2020 Aug 31.
PubMed 32866050Chen KJ, Gao SS, Duangthip D, Lo ECM, Chu CH. The caries-arresting effect of incorporating functionalized tricalcium phosphate into fluoride varnish applied following application of silver nitrate solution in preschool children: study protocol for a randomized, double-blind clinical trial. Trials. 2018 Jul 4;19(1):352. doi: 10.1186/s13063-018-2741-1.
PubMed 29973256
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. 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 With or Without Functionalized Tricalcium Phosphate in Arresting Caries in Preschool Children
- ClinicalTrials.gov ID
- NCT03423797
- Acronym / sponsor ID
- UW 17-176
- Conditions
- Early Childhood Caries
- Keywords
- silver nitrate, sodium fluoride, dental caries, equivalence trial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 408 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 30 Aug 2020 (actual)
- First posted
- 6 Feb 2018 (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.
The objective of this study is to compare the effectiveness of 25% AgNO3 solution plus 5% NaF varnish and 25% AgNO3 solution plus 5% NaF varnish with fTCP when applied semi-annually over 30 months in arresting dentine caries of primary teeth among preschool children. Half of Participants will receive topical application of 25% AgNO3 solution and 5% NaF varnish, while the other half will receive topical application of 25% AgNO3 solution and 5% NaF varnish with fTCP.
Detailed description
Aim:The objective of this study is to compare the effectiveness of commercially available of 25% AgNO3 solution plus 5% NaF varnish and 25% AgNO3 solution plus 5% NaF varnish with fTCP when applied semi-annually over 30 months in arresting dentine caries of primary teeth among preschool children.
Methods: The extension of the Consolidated Standards of Reporting Trials 2010 Statement will be followed for this 30-month, randomised, double-blinded, equivalence clinical trial. Approximately 2,000 kindergarten children will be screened and at least 376 children with caries will be recruited. This sample size is sufficient for an appropriate statistical analysis. 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 25% AgNO3 solution followed by a 5% NaF varnish with functionalized tricalcium phosphate (fTCP).Clinical examinations will be conducted at 6-month intervals to assess whether the caries are arrested (primary outcome). 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 5% NaF varnish with and without fTCP are equivalent in arresting dentine caries of primary teeth in preschool children when applied semi-annually.
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 |
|---|---|---|
| NaF without fTCP | Active comparator | Drug: 25% AgNO3 solution followed by 5% NaF25% AgNO3 solution followed by 5% NaF. |
| NaF with fTCP | Experimental | Drug: 25% AgNO3 solution followed by 5% NaF with fTCP25% AgNO3 solution followed by 5% NaF with fTCP. |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- have at least one tooth with cavitated dentine carious lesion
Key exclusion criteria (1 listed)
- Children have severe forms of dental hypoplasia, under dental treatment or wearing orthodontic devices, have major systemic illness, and are on long-term medication.
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% NaFAlso: 5% NaF without fTCPDosage: 25% AgNO3 solution 7.9mg(Ag+)/0.05ml (max dose), 5% NaF: 11.6mg (F-)/0.5ml (max dose). | Drug | NaF without fTCP |
| 25% AgNO3 solution followed by 5% NaF with fTCPAlso: 5% NaF with fTCPDosage: 25% AgNO3 solution 7.9mg(Ag+)/0.05ml (max dose), 5% NaF with fTCP: 11.6mg (F-)/0.5ml (max dose). | Drug | NaF with fTCP |
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
The effectiveness of adjunctive application of 25% AgNO3 solution and 5% NaF varnish with or without fTCP is expected to be equivalent in arresting dentine caries of primary teeth.
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 4 Nov 2020.
- Derived from this study: PubMed 32866050Chen KJ, Gao SS, Duangthip D, Lo ECM, Chu CH. Randomized Clinical Trial on Sodium Fluoride with Tricalcium Phosphate. J Dent Res. 2021 Jan;100(1):66-73. doi: 10.1177/0022034520952031. Epub 2020 Aug 31.
- Derived from this study: PubMed 29973256Chen KJ, Gao SS, Duangthip D, Lo ECM, Chu CH. The caries-arresting effect of incorporating functionalized tricalcium phosphate into fluoride varnish applied following application of silver nitrate solution in preschool children: study protocol for a randomized, double-blind clinical trial. Trials. 2018 Jul 4;19(1):352. doi: 10.1186/s13063-018-2741-1.
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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, Ph.D 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 and 25% AgNO3 solution followed by 5% NaF with fTCP 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 4 Nov 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 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 NCT03423797, 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 4 Nov 2020.