Clinical Analysis of a Risk-graded and Comprehensive Intervention for Early-childhood-caries

NCT05260216 | Unknown

• 1 other identifier: CARGACIFECC
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 1

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.

Conditions

Early Childhood Caries

Keywords

Caries risk assessment

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, one year follow up and two year follow up.

Secondary Outcomes (1)

• Caries prevalence and the change between different time points.

  Baseline, one year follow up and two year follow up.

Study Arms (3)

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.

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.

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.

Combination Product: Routine prevention

Interventions

Comprehensive prevention and treatment COMBINATION_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.

Experimental subgroup of Cariogram; Experimental subgroup of Cariostat

Routine prevention COMBINATION_PRODUCT

Routine prevention includes fluoride foam application twice a year and oral hygiene guidance.

Control group

Eligibility Criteria

• Age: 3 Years - 4 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Friendship Hospital: lead

Study Sites (1)

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, 10000, China

RECRUITING

MeSH Terms

Interventions

Therapeutics

Study Officials

• Menglin Cheng, Doctor

  Beijing Friendship Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Menglin Cheng, Doctor

CONTACT

80838416; chengmenglin2011@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: After the data is entered, the analyst is analyzed under the premise of uninformed, and the packet is performed after all analyzes are completed.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2021
• First Posted: March 2, 2022
• Study Start: November 4, 2021
• Primary Completion: August 31, 2022
• Study Completion: August 31, 2024
• Last Updated: July 21, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: When the two years follow up is completed and the result and conclusion of the study is published, the data will become available for half a year.
• Access Criteria: The sharing criteria in this study is to the research leader who register study with key words of Caries Risk Assessment on the Clinical Trail.

Locations

CN (1)