Early Childhood CariesNCT05260216
Clinical Analysis of a Risk-graded and Comprehensive Intervention for Early-childhood-caries
A study testing Comprehensive prevention and treatment and Routine prevention in people with Early Childhood Caries, run by Beijing Friendship Hospital at 1 site in China.
Trial summary
Cariogram and Cariostat will be used to assess the risk of caries in kindergarten children aged 3 years. Routine preventive measures will be taken for children at low risk of caries, and intensive intervention measures will be taken for children at medium and high risk. Read more about this study
- Who is it for?
- Ages 3 to 4 yearsHealthy volunteers can take part
- Conditions the study is for
- Early Childhood Caries
- What is being tested?
- Comprehensive prevention and treatment and Routine prevention
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 480 participants
- Where
- 1 siteChina
- Study dates
- 4 Nov 2021to 31 Aug 2024
- 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
- Healthy volunteers accepted
- Child
Who may be able to join
- Junior kindergarten children who enter the kindergarten in September 2021 and can cooperate with the oral health examination.
- Parents of children fully understand the purpose of the study, cooperate with the questionnaire survey during the study, give informed consent and sign the informed consent form.
- The child has no serious systemic diseases, has not taken hormones and immunosuppressants within 6 months, and has no history of antibiotic use within 1 month，and is not allergic to fluoride.
Who cannot join
- Parents of children refuse to provide information about children's oral health or questionnaires.
- Children cannot cooperate with oral health examination.
- The child has a serious systemic disease that may affect the results of the study.
- Children who are allergic to fluoride.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 10000
Menglin Cheng, Doctor, 80838416, chengmenglin2011@126.com
About this study
Official title: Clinical Analysis of Cariogram and Cariostat for Risk Assessment and Comprehensive Intervention of Early-childhood-caries
Cariogram and Cariostat will be used to assess the risk of caries in kindergarten children aged 3 years. Routine preventive measures will be taken for children at low risk of caries, and intensive intervention measures will be taken for children at medium and high risk. Routine measures will be taken for the control group. After one and two year, the prevalence of caries in the experimental group and the control group should be evaluated, and the cost-effectiveness evaluation will be conducted.
Read the detailed description
Caries risk-graded intervention for preschool children is needed as different child has different risk to suffer from caries.
Cariogram and Cariostat are two different and common caries risk assessment tools. Cariogram is a complicated but economical computer program which is more sensitive for caries risk assessment. Cariostat is a biological reagents with high specificity but it may be expensive to use for large numbers of children.
The experimental group will be divided into two subgroups, one use Cariogram and the other use Cariostat to assess the risk. Based on the results of the assessment, children with low risk of caries will get routine prevention including twice fluorinated foams each year and hygiene. Children with middle or high risk of caries will receive twice fluorinated varnish each year and professional caries treatment in addition to routine prevention.Routine prevention will be taken for the control group with both Cariogram and Cariostat assessment.
Follow-up will arrange one and two years after baseline recruitment. All participants will receive oral health-related questionnaires at baseline and follow-up.
The prevalence of caries in the experimental group and the control group should be evaluated, and the cost-effectiveness evaluation will be conducted.
- Conditions
- Early Childhood Caries
- Being tested
- Comprehensive prevention and treatment, Routine prevention
- Keywords
- Caries risk assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive prevention and treatmentCombination product
Children with low risk of caries will receive routine prevention including fluoride foam application twice a year and oral hygiene guidance. Children with middle or high risk of caries will receive fluoride varnish application twice a year and caries restorative treatment in addition to routine prevention. The risk-graded intervention is one kind of comprehensive prevention and treatment.
Routine preventionCombination product
Routine prevention includes fluoride foam application twice a year and oral hygiene guidance.
| Study group | Role | What they receive |
|---|---|---|
| Experimental subgroup of Cariostat | Experimental | Use Cariostat as the caries risk assessment tool to divide the children into different risk levels. Based on the results, children with low risk of caries will receive twice fluoride foam each year and oral hygiene guidance, children with middle or high risk of caries will receive forth fluoride applications each year, oral hygiene guidance and professional caries treatment. Receives: Combination Product: Comprehensive prevention and treatment |
| Experimental subgroup of Cariogram | Experimental | Use Cariogram as the caries risk assessment tool to divide the children into different risk levels. Based on the results, children with low risk of caries will receive twice fluoride foam each year and oral hygiene guidance, children with middle or high risk of caries will receive forth fluoride applications each year, oral hygiene guidance and professional caries treatment. Receives: Combination Product: Comprehensive prevention and treatment |
| Control group | Placebo comparator | Use Cariogram and as the caries risk assessment tool to divide the children into different risk levels. All children will receive routine prevention including wice fluoride foam each year and oral hygiene guidance. Receives: Combination Product: Routine prevention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decay teeth,Missed teeth and filled teeth (DMFT) and the change between different time points.
The average value of the sum of the number of decayed teeth, the number of filled teeth, and the number of missed teeth due to caries.
Measured: Baseline, one year follow up and two year follow up.
Secondary outcomes (1)
Caries prevalence and the change between different time points.
The proportion of population with caries in the whole participants.
Measured: Baseline, one year follow up and two year follow up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start4 Nov 2021
- Primary completion31 Aug 2022 (estimated)
- Study completion31 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Childhood CariesStudies of the same condition, open and under way.
- More trials run by Beijing Friendship HospitalThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Menglin Cheng, Doctor, Principal investigator, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05260216
- Sponsor's protocol ID
- CARGACIFECC
- Status last verified
- Dec 2021
- First submitted
- 12 Dec 2021
- Last updated
- 21 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study protocol, statistical analysis plan, informed consent form and clinical study report are to be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Analysis of Cariogram and Cariostat for Risk Assessment and Comprehensive Intervention of Early-childhood-caries
- ClinicalTrials.gov ID
- NCT05260216
- Acronym / sponsor ID
- CARGACIFECC
- Conditions
- Early Childhood Caries
- Keywords
- Caries risk assessment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Study start
- 4 Nov 2021 (actual)
- Primary completion
- 31 Aug 2022 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 2 Mar 2022 (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.
Cariogram and Cariostat will be used to assess the risk of caries in kindergarten children aged 3 years. Routine preventive measures will be taken for children at low risk of caries, and intensive intervention measures will be taken for children at medium and high risk. Routine measures will be taken for the control group. After one and two year, the prevalence of caries in the experimental group and the control group should be evaluated, and the cost-effectiveness evaluation will be conducted.
Detailed description
Caries risk-graded intervention for preschool children is needed as different child has different risk to suffer from caries.
Cariogram and Cariostat are two different and common caries risk assessment tools. Cariogram is a complicated but economical computer program which is more sensitive for caries risk assessment. Cariostat is a biological reagents with high specificity but it may be expensive to use for large numbers of children.
The experimental group will be divided into two subgroups, one use Cariogram and the other use Cariostat to assess the risk. Based on the results of the assessment, children with low risk of caries will get routine prevention including twice fluorinated foams each year and hygiene. Children with middle or high risk of caries will receive twice fluorinated varnish each year and professional caries treatment in addition to routine prevention.Routine prevention will be taken for the control group with both Cariogram and Cariostat assessment.
Follow-up will arrange one and two years after baseline recruitment. All participants will receive oral health-related questionnaires at baseline and follow-up.
The prevalence of caries in the experimental group and the control group should be evaluated, and the cost-effectiveness evaluation will be conducted.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental subgroup of Cariostat | Experimental | Combination Product: Comprehensive prevention and treatmentUse Cariostat as the caries risk assessment tool to divide the children into different risk levels. Based on the results, children with low risk of caries will receive twice fluoride foam each year and oral hygiene guidance, children with middle or high risk of caries will receive forth fluoride applications each year, oral hygiene guidance and professional caries treatment. |
| Experimental subgroup of Cariogram | Experimental | Combination Product: Comprehensive prevention and treatmentUse Cariogram as the caries risk assessment tool to divide the children into different risk levels. Based on the results, children with low risk of caries will receive twice fluoride foam each year and oral hygiene guidance, children with middle or high risk of caries will receive forth fluoride applications each year, oral hygiene guidance and professional caries treatment. |
| Control group | Placebo comparator | Combination Product: Routine preventionUse Cariogram and as the caries risk assessment tool to divide the children into different risk levels. All children will receive routine prevention including wice fluoride foam each year and oral hygiene guidance. |
Who may qualify
- Ages
- 3 to 4 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Junior kindergarten children who enter the kindergarten in September 2021 and can cooperate with the oral health examination.
- Parents of children fully understand the purpose of the study, cooperate with the questionnaire survey during the study, give informed consent and sign the informed consent form.
- The child has no serious systemic diseases, has not taken hormones and immunosuppressants within 6 months, and has no history of antibiotic use within 1 month，and is not allergic to fluoride.
Key exclusion criteria (4 listed)
- Parents of children refuse to provide information about children's oral health or questionnaires.
- Children cannot cooperate with oral health examination.
- The child has a serious systemic disease that may affect the results of the study.
- Children who are allergic to fluoride.
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 |
|---|---|---|
| Comprehensive prevention and treatmentChildren with low risk of caries will receive routine prevention including fluoride foam application twice a year and oral hygiene guidance. Children with middle or high risk of caries will receive fluoride varnish application twice a year and caries restorative treatment in addition to routine prevention. The risk-graded intervention is one kind of comprehensive prevention and treatment. | Combination product | Experimental subgroup of Cariogram, Experimental subgroup of Cariostat |
| Routine preventionRoutine prevention includes fluoride foam application twice a year and oral hygiene guidance. | Combination product | Control group |
Primary outcome
Decay teeth,Missed teeth and filled teeth (DMFT) and the change between different time points.
Time frame: Baseline, one year follow up and two year follow up.
The average value of the sum of the number of decayed teeth, the number of filled teeth, and the number of missed teeth due to caries.
1 secondary outcome
Caries prevalence and the change between different time points.
Time frame: Baseline, one year follow up and two year follow up.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2022.
- Individual participant dataSharing planned: Yes. The study protocol, statistical analysis plan, informed consent form and clinical study report are to be shared with other researchers.
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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.
Menglin Cheng, Doctor principal investigator
Beijing Friendship Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comprehensive prevention and treatment and Routine prevention in people with Early Childhood Caries, run by Beijing Friendship Hospital 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 3 inclusion and 4 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 21 Jul 2022. 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.
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?
Contact Menglin Cheng, Doctor (80838416, chengmenglin2011@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decay teeth,Missed teeth and filled teeth (DMFT) and the change between different time points. (time frame: Baseline, one year follow up and two year follow up.). 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 21 Jul 2022.