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

Effectiveness of the International Caries Classification and Management System (ICCMS) in Reducing the Incidence of Dental Caries in Children Attending to the CURUMIM Social Project, Sesc/São Paulo(SP)

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.

Study Overview

• Status: Unknown
• Conditions: Dental Caries
• Intervention / Treatment: Other: ICCMS; Other: SESC standard care

• Study Type: Interventional
• Enrollment (Anticipated): 460
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mariana M Braga, PhD; Phone Number: 551130917835; Email: mmbraga@usp.br
• Study Contact Backup: Name: Gabriela S Oliveira; Phone Number: 5511961269255; Email: gabriela.sa.oliveira@usp.br

Study Locations

• Brazil
  • São Paulo, Brazil
    • Recruiting
    • University of São Paulo
    • Contact: Mariana M Braga

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 12 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Test - ICCMS; The 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)	Other: ICCMS; 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 treatment is divided into Non-Operative Care and Tooth-Preserving Operative Care (restorations with minimal intervention to preserve maximum dental structure). 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)
ACTIVE_COMPARATOR: Control - Standard care SESC; The 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.	Other: SESC standard care; Standard care related to: Caries Diagnosis, operative and non-operative treatments, Indication of recall interval according to the dentist opinion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of caries	New cavitated caries lesions	2 years
Cost-effectiveness	Ratio between the difference in costs and in effects regarding the programs	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
New initial caries lesions	New initial caries lesions	2 years
Qualitative measurement of difficulties and issues during the programs implementation	Health professional views about the program implementation (impact) collected periodically by a structured online report followed by an interview	2 years
Oral Health-Related Quality of Life (OHRQoL)	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	2 years

Collaborators and Investigators

• Sponsor: University of Sao Paulo
• Collaborators: Serviço Social do Comércio - SESC

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 16, 2017
• Primary Completion (ANTICIPATED): June 1, 2021
• Study Completion (ANTICIPATED): December 1, 2021

Study Registration Dates

• First Submitted: March 20, 2018
• First Submitted That Met QC Criteria: April 3, 2018
• First Posted (ACTUAL): April 4, 2018

Study Record Updates

• Last Update Posted (ACTUAL): April 4, 2018
• Last Update Submitted That Met QC Criteria: April 3, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Dental Caries, ICCMS, Risk Assessment
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries
• Other Study ID Numbers: CURUMIM

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No