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

NCT03488056 | Unknown

• 1 other identifier: CURUMIM
• Study Type: interventional
• Target: 460
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Caries

Keywords

Dental Caries, ICCMS, Risk Assessment

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• New initial caries lesions

  2 years

• Qualitative measurement of difficulties and issues during the programs implementation

  2 years

• Oral Health-Related Quality of Life (OHRQoL)

  2 years

Study Arms (2)

Test - ICCMS

EXPERIMENTAL

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

Control - Standard care SESC

ACTIVE COMPARATOR

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

Interventions

ICCMS OTHER

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)

Test - ICCMS

SESC standard care OTHER

Standard care related to: Caries Diagnosis, operative and non-operative treatments, Indication of recall interval according to the dentist opinion

Control - Standard care SESC

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Sao Paulo: lead
• Serviço Social do Comércio - SESC: collaborator

Study Sites (1)

University of São Paulo

São Paulo, Brazil

RECRUITING

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Mariana M Braga

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mariana M Braga, PhD

CONTACT

551130917835; mmbraga@usp.br

Gabriela S Oliveira

CONTACT

5511961269255; gabriela.sa.oliveira@usp.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The division of the control and experimental groups was done by center and for neither group are revealed to the patient nor responsible for the type of intervention they are undergoing. After a certain time of the study, a blind investor will examine the children's centers and evaluate the outcome of the study. This researcher will not know which center is a control or experimental group.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: The randomization was made by centers of the SESC (Social Service of the Commerce) of São Paulo state. Four centers will follow the ICCMS criteria and four other centers will follow criteria for diagnosis and treatment of SESC. The randomization will be stratified by sociodemographical conditions. The minimization will be used to equate preexisting oral health-related activities. According to allocated strategy, dentists in the center will guide their conduct with children attended to the CURUMIM project.

Study Record Dates

• First Submitted: March 20, 2018
• First Posted: April 4, 2018
• Study Start: November 16, 2017
• Primary Completion: June 1, 2021
• Study Completion: December 1, 2021
• Last Updated: April 4, 2018

Record last verified: 2018-04

Locations

BR (1)