MedPath

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

Not Applicable
Conditions
Dental Caries
Interventions
Other: SESC standard care
Other: ICCMS
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

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.
Read More
Exclusion Criteria
  • Children with cognitive impairment, motor impairment and feeding tube.
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Control - Standard care SESCSESC standard careThe clinical sequence in this group will be: Caries Diagnosis Operative and non-operative treatments Indication of recall interval according to the dentist However, dentists will do that without a schematic guide to follow. They will do as they usually do in their practices.
Test - ICCMSICCMSThe dentists will perform clinical examination on children following the ICCMS sequence: The patient's caries risk assessment, Diagnosis of caries lesion and activity assessment Intraoral risk assessment, Decide on a personalized care plan for patient and clinical interventions.After asses all the factors and defining the patient's individual risk, the system presents a personalized treatment plan, indicating the appropriate home care instructions, clinical interventions and specific treatment for each caries lesion categories. The return intervals will be scheduled according to the risk: low risk (return of 1 year), moderate risk (6 months) and high risk (3 months)
Primary Outcome Measures
NameTimeMethod
Incidence of caries2 years

New cavitated caries lesions

Cost-effectiveness2 years

Ratio between the difference in costs and in effects regarding the programs

Secondary Outcome Measures
NameTimeMethod
New initial caries lesions2 years

New initial caries lesions

Qualitative measurement of difficulties and issues during the programs implementation2 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

© Copyright 2025. All Rights Reserved by MedPath