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

Primary Purpose

Dental Caries

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
ICCMS
SESC standard care
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dental Caries focused on measuring Dental Caries, ICCMS, Risk Assessment

Eligibility Criteria

7 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of São PauloRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Test - ICCMS

Control - Standard care SESC

Arm Description

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)

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.

Outcomes

Primary Outcome Measures

Incidence of caries
New cavitated caries lesions
Cost-effectiveness
Ratio between the difference in costs and in effects regarding the programs

Secondary Outcome Measures

New initial caries lesions
New initial caries lesions
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
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

Full Information

First Posted
March 20, 2018
Last Updated
April 3, 2018
Sponsor
University of Sao Paulo
Collaborators
Serviço Social do Comércio - SESC
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1. Study Identification

Unique Protocol Identification Number
NCT03488056
Brief Title
Effectiveness of ICCMS in Reducing the Incidence of Dental Caries in Children
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 16, 2017 (Actual)
Primary Completion Date
June 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
Collaborators
Serviço Social do Comércio - SESC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries
Keywords
Dental Caries, ICCMS, Risk Assessment

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
ParticipantOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
460 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Test - ICCMS
Arm Type
Experimental
Arm Description
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)
Arm Title
Control - Standard care SESC
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
ICCMS
Intervention Description
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
Intervention Name(s)
SESC standard care
Intervention Description
Standard care related to: Caries Diagnosis, operative and non-operative treatments, Indication of recall interval according to the dentist opinion
Primary Outcome Measure Information:
Title
Incidence of caries
Description
New cavitated caries lesions
Time Frame
2 years
Title
Cost-effectiveness
Description
Ratio between the difference in costs and in effects regarding the programs
Time Frame
2 years
Secondary Outcome Measure Information:
Title
New initial caries lesions
Description
New initial caries lesions
Time Frame
2 years
Title
Qualitative measurement of difficulties and issues during the programs implementation
Description
Health professional views about the program implementation (impact) collected periodically by a structured online report followed by an interview
Time Frame
2 years
Title
Oral Health-Related Quality of Life (OHRQoL)
Description
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
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mariana M Braga, PhD
Phone
551130917835
Email
mmbraga@usp.br
First Name & Middle Initial & Last Name or Official Title & Degree
Gabriela S Oliveira
Phone
5511961269255
Email
gabriela.sa.oliveira@usp.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mariana M Braga
Organizational Affiliation
University of São Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of São Paulo
City
São Paulo
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mariana M Braga

12. IPD Sharing Statement

Learn more about this trial

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

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