Clinical trial NCT05260216: Clinical Analysis of a Risk-graded and Comprehensive Intervention for Early-childhood-caries
Official title: Clinical Analysis of Cariogram and Cariostat for Risk Assessment and Comprehensive Intervention of Early-childhood-caries
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Early Childhood Caries
Keywords: Caries risk assessment
Lead sponsor: Beijing Friendship Hospital
Sponsor class: OTHER
First posted: 2022-03-02
Enrollment: 480
Sex: ALL
Minimum age (years): 3
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

1. Junior kindergarten children who enter the kindergarten in September 2021 and can cooperate with the oral health examination.
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:

1. Parents of children refuse to provide information about children's oral health or questionnaires.
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.

Primary outcomes:
measure: Decay teeth,Missed teeth and filled teeth (DMFT) and the change between different time points.
timeFrame: Baseline, one year follow up and two year follow up.
Secondary outcomes:
measure: Caries prevalence and the change between different time points.
timeFrame: Baseline, one year follow up and two year follow up.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Friendship Hospital, Capital Medical University
state: Beijing
Study officials:
affiliation: Beijing Friendship Hospital
name: Menglin Cheng, Doctor
role: PRINCIPAL_INVESTIGATOR
References: