Dental Caries in ChildrenNCT05025163
Cost-effectiveness of Topical Fluoride in Preventing Deciduous Dental Caries in Preschool Children
A study testing 1.23% fluoride foam application and 2.26% fluoride varnish application in people with Dental Caries in Children, run by National Center for Chronic and Noncommunicable Disease Control and Prevention, China CDC.
Trial summary
Fluoride foam and fluoride varnish are effectiveness in prevention deciduous dental caries. However, the relative clinical efficacy and cost-effectiveness of these two interventions are uncertain. Read more about this study
- Who is it for?
- Ages 3 to 4 years
- Conditions the study is for
- Dental Caries in Children
- What is being tested?
- 1.23% fluoride foam application and 2.26% fluoride varnish application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,083 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2016to 28 Dec 2018
- Phase
- Interventional
- 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
None listed.
Who cannot join
- Children who are unable to cooperate or have a strong vomiting reflex;
- Children with a history of asthma or allergies;
- Children with other contraindications specified in the product manual.
About this study
Official title: Cost-effectiveness Analysis of Fluoride Foam and Fluoride Varnish in Preventing Dental Caries in the Primary Teeth of Preschool Children With High Caries Risk
Fluoride foam and fluoride varnish are effectiveness in prevention deciduous dental caries. However, the relative clinical efficacy and cost-effectiveness of these two interventions are uncertain. This study aims to evaluate the relative clinical effectiveness and cost-effectiveness of fluoride foam and fluoride varnish in preventing dental caries in the primary teeth of preschool children with high caries risk.
Read the detailed description
This 24-month randomized clinical trial aims to compare the clinical efficacy and cost-effectiveness of topical fluoride application of fluoride foam and fluoride varnish in preventing dental caries in the primary teeth of preschool children with high caries risk in Harbin,Heilongjiang Province,China.
Preschool children (3-4 years) with high caries risk will be invited to participant in this study. An invitation letter will be sent to the parents explaining the purpose and procedures of this study.Parental concent will be sought.
The children will be randomly divided into three groups: the control group-no intervention; the intervention group 1 - applications of 1.23% fluoride foam every 6 months; the intervention group 2- applications of 2.26% fluoride varnish every 6 months.
Dental clinical examination of the children will be performed at the beginning of the study,12 months and 24 months later.The dental examiners will receive unified training and consistency test of dental caries survey.Only when the Kappa value reached 0.8 can oral examiners participate in the oral examination.Dental caries condition will be recorded. Approximately 5% of children will be re-examined to determine the reliability of the results.
The status of any possible side/adverse effects will be recorded in the follow-up examinations.
The data of the study will be analysed by SPSS Statistical Analysis Software.The differences among the groups will be calculated and compared. And p<0.05 will be considered statistically significant.
- Conditions
- Dental Caries in Children
- Being tested
- 1.23% fluoride foam application, 2.26% fluoride varnish application
- Keywords
- cost effectiveness, fluoride foam, fluoride varnish, dental caries, clinical 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.
1.23% fluoride foam applicationDrug
Also called fluoride foam
topical application of fluoride foam every 6 months
2.26% fluoride varnish applicationDrug
Also called Duraphat (Colgate)
topical application of fluoride varnish every 6 months
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | no intervention in the control group |
| fluoride foam group | Experimental | intervention; fluoride foam application (with 1.23% fluoride foam application on teeth ) Receives: Drug: 1.23% fluoride foam application |
| fluoride varnish group | Experimental | intervention; fluoride varnish application (with 2.26% fluoride varnish application on teeth) Receives: Drug: 2.26% fluoride varnish application |
What is being measured
The primary outcome is the main question the study is designed to answer.
The mean number of decayed,missing and filled teeth at baseline,12 months and 24 months
The mean number of decayed,missing and filled teeth in fluoride foam group,fluoride varnish group and control group at baseline,12 months and 24 months
Measured: 24 months
The mean number of decayed,missing and filled teeth surfaces at baseline,12 months and 24 months
The mean number of decayed,missing and filled teeth surfaces in fluoride foam group,fluoride varnish group and control group at baseline,12 months and 24 months
Measured: 24 months
The change of mean number of decayed,missing and filled teeth at baseline,12 months and 24 months
The change of mean number of decayed,missing and filled teeth in fluoride foam group,fluoride varnish group and control group at baseline,12 months and 24 months
Measured: 24 months
The change of mean number of decayed,missing and filled teeth surfaces at baseline,12 months and 24 months
The change of mean number of decayed,missing and filled teeth surfaces in fluoride foam group,fluoride varnish group and control group at baseline,12 months and 24 months
Measured: 24 months
Secondary outcomes (1)
The mean cost per caries avoided after 12 months and 24 months
The mean cost per caries avoided in fluoride foam group and fluoride varnish group after 12 months and 24 months
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2021
- Study start1 Jul 2016
- Primary completion16 Oct 2018
- Study completion28 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Caries in ChildrenStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 1,083 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Center for Chronic and Noncommunicable Disease Control and Prevention, China CDC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chunxiao Wang, Study director, National Center for Chronic and Noncommunicable Disease Control and Prevention, China CDC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05025163
- Sponsor's protocol ID
- NCNCD
- Status last verified
- Nov 2021
- First submitted
- 23 Aug 2021
- Last updated
- 12 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cost-effectiveness Analysis of Fluoride Foam and Fluoride Varnish in Preventing Dental Caries in the Primary Teeth of Preschool Children With High Caries Risk
- ClinicalTrials.gov ID
- NCT05025163
- Acronym / sponsor ID
- NCNCD
- Conditions
- Dental Caries in Children
- Keywords
- cost effectiveness, fluoride foam, fluoride varnish, dental caries, clinical trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,083 participants (actual)
- Lead sponsor
- National Center for Chronic and Noncommunicable Disease Control and Prevention, China CDCUniversity, hospital or other
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 16 Oct 2018 (actual)
- Study completion
- 28 Dec 2018 (actual)
- First posted
- 27 Aug 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.
Fluoride foam and fluoride varnish are effectiveness in prevention deciduous dental caries. However, the relative clinical efficacy and cost-effectiveness of these two interventions are uncertain. This study aims to evaluate the relative clinical effectiveness and cost-effectiveness of fluoride foam and fluoride varnish in preventing dental caries in the primary teeth of preschool children with high caries risk.
Detailed description
This 24-month randomized clinical trial aims to compare the clinical efficacy and cost-effectiveness of topical fluoride application of fluoride foam and fluoride varnish in preventing dental caries in the primary teeth of preschool children with high caries risk in Harbin,Heilongjiang Province,China.
Preschool children (3-4 years) with high caries risk will be invited to participant in this study. An invitation letter will be sent to the parents explaining the purpose and procedures of this study.Parental concent will be sought.
The children will be randomly divided into three groups: the control group-no intervention; the intervention group 1 - applications of 1.23% fluoride foam every 6 months; the intervention group 2- applications of 2.26% fluoride varnish every 6 months.
Dental clinical examination of the children will be performed at the beginning of the study,12 months and 24 months later.The dental examiners will receive unified training and consistency test of dental caries survey.Only when the Kappa value reached 0.8 can oral examiners participate in the oral examination.Dental caries condition will be recorded. Approximately 5% of children will be re-examined to determine the reliability of the results.
The status of any possible side/adverse effects will be recorded in the follow-up examinations.
The data of the study will be analysed by SPSS Statistical Analysis Software.The differences among the groups will be calculated and compared. And p<0.05 will be considered statistically significant.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –no intervention in the control group |
| fluoride foam group | Experimental | Drug: 1.23% fluoride foam applicationintervention; fluoride foam application (with 1.23% fluoride foam application on teeth ) |
| fluoride varnish group | Experimental | Drug: 2.26% fluoride varnish applicationintervention; fluoride varnish application (with 2.26% fluoride varnish application on teeth) |
Who may qualify
- Ages
- 3 to 4 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- Children who are unable to cooperate or have a strong vomiting reflex;
- Children with a history of asthma or allergies;
- Children with other contraindications specified in the product manual.
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 |
|---|---|---|
| 1.23% fluoride foam applicationAlso: fluoride foamtopical application of fluoride foam every 6 months | Drug | fluoride foam group |
| 2.26% fluoride varnish applicationAlso: Duraphat (Colgate)topical application of fluoride varnish every 6 months | Drug | fluoride varnish group |
Primary outcome
The mean number of decayed,missing and filled teeth at baseline,12 months and 24 months
Time frame: 24 months
The mean number of decayed,missing and filled teeth in fluoride foam group,fluoride varnish group and control group at baseline,12 months and 24 months
The mean number of decayed,missing and filled teeth surfaces at baseline,12 months and 24 months
Time frame: 24 months
The mean number of decayed,missing and filled teeth surfaces in fluoride foam group,fluoride varnish group and control group at baseline,12 months and 24 months
The change of mean number of decayed,missing and filled teeth at baseline,12 months and 24 months
Time frame: 24 months
The change of mean number of decayed,missing and filled teeth in fluoride foam group,fluoride varnish group and control group at baseline,12 months and 24 months
The change of mean number of decayed,missing and filled teeth surfaces at baseline,12 months and 24 months
Time frame: 24 months
The change of mean number of decayed,missing and filled teeth surfaces in fluoride foam group,fluoride varnish group and control group at baseline,12 months and 24 months
1 secondary outcome
The mean cost per caries avoided after 12 months and 24 months
Time frame: 24 months
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 12 Nov 2021.
- Individual participant dataSharing planned: No
Related trials for Dental Caries in Children
Not yet recruiting
Safety of Intraosseous Anaesthesia in Children With Haemophilia
Haemophilia A, Haemophilia B
Not yet recruiting
This Feasibility Study Will Evaluate the Study Protocols for Treatment and Follow-up Controls of Primary Molars With Caries in Children Treated With Stainless Steel Crowns or Conventional Fillings. Treatment Success and Potential Failures Will be Followed at 3, 6 and 12 Months Post Treatment.
Dental Caries, Early Childhood Caries (ECC)
Recruiting
A Study to Evaluate the Cariostatic Efficacy of Nano Silver Fluoride (NSF) vs. Silver Diamine Fluoride (SDF) in Children
Dental Caries
Not yet recruiting
Effect of Bioactive Glass Varnish on Salivary Parameters in Children: Randomized Controlled Trial
Prevention of Dental Caries
Active, not recruiting
Luting Cements for Prefabricated Zirconia Crown Retention in Primary Anterior Teeth in Children
Dental Caries, Tooth Injuries
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.
Chunxiao Wang study director
National Center for Chronic and Noncommunicable Disease Control and Prevention, China CDC
Questions about this trial
What is this clinical trial studying?
A study testing 1.23% fluoride foam application and 2.26% fluoride varnish application in people with Dental Caries in Children, run by National Center for Chronic and Noncommunicable Disease Control and Prevention, China CDC.
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 0 inclusion and 3 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 12 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
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.
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 mean number of decayed,missing and filled teeth at baseline,12 months and 24 months (time frame: 24 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Nov 2021.