Effectiveness of ICCMS in Reducing the Incidence of Dental Caries in Children

Not Applicable

• Conditions: Dental Caries

• Registration Number: NCT03488056
• Lead Sponsor: University of Sao Paulo

Brief Summary

The aim of the present study is to evaluate the effectiveness of using the ICCMS (International Caries Classification And Management System)in reducing caries lesions incidence compared to a control group that use different criteria as a not systematic and standardized prevention strategy. The study will be performed among children attending to the social project of Social Service of Commerce (SESC), Sao Paulo. The sample will be composed of 460 children aging between 7 to 12 years old registered in CURUMIM Program from eight dental centers of SESC. A randomized controlled study with parallel group will be conducted. The centers will be randomized between the 2 strategies, defining 2 groups with 4 centers each. The experimental group that will follow the criteria defined by the ICCMS will evaluate clinical and behavioral variables, it will define: evaluation of the caries risk of the patient, evaluation of the intraoral risk, diagnosis of the caries lesion and its respective activity, plan decision individualized treatment for the patient and indication of recall interval according to the risk of caries. In the control group, children need will be solved according to rthe routinely dental practices in the center, but the determination of the child's general and intraoral risk of developing new caries lesions will not be performed nor the scheduling of specific recall intervals according to the risk.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-16
• Study First Submitted: 2018-03-20
• Status Verified: 2018-04
• Study First Submitted QC: 2018-04-03
• Last Update Submitted: 2018-04-03
• Study First Posted: 2018-04-04
• Last Update Posted: 2018-04-04
• Primary Completion: 2021-06
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 460

Inclusion Criteria

• Children who participate in the CURUMIM Program
• Children whose parents sign the term of informed consent confirming their participation.

Exclusion Criteria

• Children with cognitive impairment, motor impairment and feeding tube.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Incidence of caries	2 years	New cavitated caries lesions
Cost-effectiveness	2 years	Ratio between the difference in costs and in effects regarding the programs

Secondary Outcome Measures

Name	Time	Method
New initial caries lesions	2 years	New initial caries lesions
Qualitative measurement of difficulties and issues during the programs implementation	2 years	Health professional views about the program implementation (impact) collected periodically by a structured online report followed by an interview
Oral Health-Related Quality of Life (OHRQoL)	2 years	Difference in Oral Health-Related Quality of Life (OHRQoL) scores using the Brazilian validated version of Early Childhood Oral Health Impact Scale (ECOHIS) questionnaire (before and after treatment). Bigger the difference, bigger the impact of the program on children's OHRQoL

Trial Locations

Locations (1)

University of São Paulo; 🇧🇷 São Paulo, Brazil