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Cohort Zero Caries (CZC)

Primary Purpose

Dental Caries, Early Childhood Caries

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Motivational Interview
Traditional health education
Sponsored by
Hospital Nossa Senhora da Conceicao
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dental Caries focused on measuring Early Childhood Caries, Randomized clinical trial, Motivational Interviewing

Eligibility Criteria

12 Months - 14 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Children born in 2014 in the attended territory of 12 Basic Health Units of the Community Health Service of Grupo Hospitalar Conceição, located in the city of Porto Alegre, Rio Grande do Sul, Brazil and who are correctly registered and under follow-up medical attention in the Children Program;
  • Mothers/fathers/responsible adults: the person responsible for the child's oral health care and who follows all dental appointments in the health unit will be considered.

Exclusion Criteria:

  • Children with special needs or syndromes;
  • Children who left the attended territory of Community Health Service of Grupo Hospitalar Conceição health units for more than 6 consecutive months;
  • Mothers/fathers/responsible adults without cognitive conditions to answer the study's surveys.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Motivational Interview

    Traditional health education

    Arm Description

    INTERVENTION GROUP: in this group, composed of 6 UBS, the children and their respective mothers/fathers/responsible adults will be attended by the dentists at least once a year with an approach based on the Motivational Interview.

    CONTROL GROUP: in this group, composed of 6 UBS, the children and their respective mother/fathers/responsible adults will be attended by the dentists at least once a year based on the recommendations by the Brazilian Ministry of Health (BRASIL,2008-a) and on SSC-GHC's protocol (BRASIL, 2008-b). Additionally, the professional guidance script and the parents' booklet of SSC-GHC's oral health Program may be used.

    Outcomes

    Primary Outcome Measures

    Reducing the prevalence of Early Childhood Caries after 3 years of follow verified by the ICDAS index (International Caries Detection & Assessment System) from the realization of reduction of at least 30% of the index pre and post intervention.

    Secondary Outcome Measures

    Full Information

    First Posted
    October 14, 2015
    Last Updated
    March 13, 2021
    Sponsor
    Hospital Nossa Senhora da Conceicao
    Collaborators
    Federal University of Rio Grande do Sul
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02578966
    Brief Title
    Cohort Zero Caries
    Acronym
    CZC
    Official Title
    Impact of Preventive Child Oral Health Programs in Primary Health Care.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2014 (undefined)
    Primary Completion Date
    December 2017 (Actual)
    Study Completion Date
    December 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hospital Nossa Senhora da Conceicao
    Collaborators
    Federal University of Rio Grande do Sul

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to compare the effectiveness of a traditional oral health educational program and a program based on the theories of the Motivational Interview directed to the child's mothers/fathers/responsible parents to reduce childhood caries (2 and 3 years of age).
    Detailed Description
    Early Childhood Caries - ECC - is a highly prevalent and severe disease that affects children during their first years of life and, hence, requires early interventions and approaches, on an individual and collective basis. Early childhood is the ideal period to introduce good habits and begin an educational/preventive oral health program; however, family participation is utmost important, especially because the child's parents or responsible adults tend to pass improper knowledge on oral health care in this stage of life. Once prioritizing educational actions directed to this audience in primary health care is essential, Grupo Hospitalar Conceição's (Conceição Hospital Group - GHC) Community Health Service implemented, in its 12 Basic Health Units (UBS), an oral health action program with the goal that all children born after 2010 have at least one dental appointment in their first, second and third year of life. In these appointments, the child's oral health conditions are evaluated and their mother/father or responsible adult receive guidance on proper oral health care; however, little is known on the effectiveness of these preventive programs and what is their impact on ECC reduction in the population. With the purpose of qualifying oral health care strategies at the Brazilian Unified Health System's Primary Health Care (APS-SUS), with a scientific background, it is necessary to assess the effectiveness of these programmatic actions in comparison with conventional dental care by free demand. In light of this, this study has a technological innovation character, with a potential to be directly applicable in the oral health care staff of the Family Health Strategy program throughout Brazil. The purpose of this study is to compare the effectiveness of a traditional oral health educational program and a program based on the theories of the Motivational Interview directed to the child's mothers/fathers/responsible parents to reduce childhood caries (2 and 3 years of age). Randomized clinical trial nested in a cohort. The study will be conducted at SSC-GHC, which is composed of 12 Basic Health Units (UBS) located in the Northern region of the city of Porto Alegre, RS-Brazil.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dental Caries, Early Childhood Caries
    Keywords
    Early Childhood Caries, Randomized clinical trial, Motivational Interviewing

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    650 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Motivational Interview
    Arm Type
    Experimental
    Arm Description
    INTERVENTION GROUP: in this group, composed of 6 UBS, the children and their respective mothers/fathers/responsible adults will be attended by the dentists at least once a year with an approach based on the Motivational Interview.
    Arm Title
    Traditional health education
    Arm Type
    Active Comparator
    Arm Description
    CONTROL GROUP: in this group, composed of 6 UBS, the children and their respective mother/fathers/responsible adults will be attended by the dentists at least once a year based on the recommendations by the Brazilian Ministry of Health (BRASIL,2008-a) and on SSC-GHC's protocol (BRASIL, 2008-b). Additionally, the professional guidance script and the parents' booklet of SSC-GHC's oral health Program may be used.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Motivational Interview
    Intervention Type
    Other
    Intervention Name(s)
    Traditional health education
    Primary Outcome Measure Information:
    Title
    Reducing the prevalence of Early Childhood Caries after 3 years of follow verified by the ICDAS index (International Caries Detection & Assessment System) from the realization of reduction of at least 30% of the index pre and post intervention.
    Time Frame
    three years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    12 Months
    Maximum Age & Unit of Time
    14 Months
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Children born in 2014 in the attended territory of 12 Basic Health Units of the Community Health Service of Grupo Hospitalar Conceição, located in the city of Porto Alegre, Rio Grande do Sul, Brazil and who are correctly registered and under follow-up medical attention in the Children Program; Mothers/fathers/responsible adults: the person responsible for the child's oral health care and who follows all dental appointments in the health unit will be considered. Exclusion Criteria: Children with special needs or syndromes; Children who left the attended territory of Community Health Service of Grupo Hospitalar Conceição health units for more than 6 consecutive months; Mothers/fathers/responsible adults without cognitive conditions to answer the study's surveys.

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    29885752
    Citation
    Colvara BC, Faustino-Silva DD, Meyer E, Hugo FN, Hilgert JB, Celeste RK. Motivational Interviewing in Preventing Early Childhood Caries in Primary Healthcare: A Community-based Randomized Cluster Trial. J Pediatr. 2018 Oct;201:190-195. doi: 10.1016/j.jpeds.2018.05.016. Epub 2018 Jun 6.
    Results Reference
    derived

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    Cohort Zero Caries

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