Cette page a été traduite automatiquement et l'exactitude de la traduction n'est pas garantie. Veuillez vous référer au version anglaise pour un texte source.

Cohort Zero Caries (CZC)

13 mars 2021 mis à jour par: Daniel Demétrio Faustino da Silva, Hospital Nossa Senhora da Conceicao

Impact of Preventive Child Oral Health Programs in Primary Health Care.

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).

Aperçu de l'étude

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Anticipé)

650

Phase

  • N'est pas applicable

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

1 an à 1 an (Enfant)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: La prévention
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Quadruple

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Motivational Interview
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.
Comparateur actif: Traditional health education
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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Délai
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.
Délai: three years
three years

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 janvier 2014

Achèvement primaire (Réel)

1 décembre 2017

Achèvement de l'étude (Anticipé)

1 décembre 2021

Dates d'inscription aux études

Première soumission

14 octobre 2015

Première soumission répondant aux critères de contrôle qualité

15 octobre 2015

Première publication (Estimation)

19 octobre 2015

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

16 mars 2021

Dernière mise à jour soumise répondant aux critères de contrôle qualité

13 mars 2021

Dernière vérification

1 mars 2021

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • HNSC-CZC

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

S'abonner