Clinical Analysis of a Risk-graded and Comprehensive Intervention for Early-childhood-caries
NCT ID: NCT05260216
Last Updated: 2022-07-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
480 participants
INTERVENTIONAL
2021-11-04
2024-08-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Experimental subgroup of Cariostat
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.
Comprehensive prevention and treatment
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.
Experimental subgroup of Cariogram
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.
Comprehensive prevention and treatment
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.
Control group
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.
Routine prevention
Routine prevention includes fluoride foam application twice a year and oral hygiene guidance.
Interventions
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Comprehensive prevention and treatment
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 prevention
Routine prevention includes fluoride foam application twice a year and oral hygiene guidance.
Eligibility Criteria
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Inclusion Criteria
2. 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.
3. 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.
Exclusion Criteria
2. Children cannot cooperate with oral health examination.
3. The child has a serious systemic disease that may affect the results of the study.
4. Children who are allergic to fluoride.
3 Years
4 Years
ALL
Yes
Sponsors
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Beijing Friendship Hospital
OTHER
Responsible Party
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Principal Investigators
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Menglin Cheng, Doctor
Role: PRINCIPAL_INVESTIGATOR
Beijing Friendship Hospital
Locations
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Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CARGACIFECC
Identifier Type: -
Identifier Source: org_study_id
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