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

NCT ID: NCT03488056

Last Updated: 2018-04-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 460 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-16
• Study Completion Date: 2021-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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)

Group Type: EXPERIMENTAL

ICCMS

Intervention Type: 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)

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.

Group Type: ACTIVE_COMPARATOR

SESC standard care

Intervention Type: OTHER

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

Interventions

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)

Intervention Type: OTHER

SESC standard care

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Serviço Social do Comércio - SESC

UNKNOWN

Sponsor Role: collaborator

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Mariana Minatel Braga

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mariana M Braga

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Locations

University of São Paulo

São Paulo, , Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Mariana M Braga, PhD

Role: CONTACT

mmbraga@usp.br

551130917835

Gabriela S Oliveira

Role: CONTACT

gabriela.sa.oliveira@usp.br

5511961269255

Facility Contacts

Mariana M Braga

Role: primary

Other Identifiers

CURUMIM

Identifier Type: -

Identifier Source: org_study_id