Cohort Zero Caries

NCT02578966 | Active Not Recruiting

• 1 other identifier: HNSC-CZC
• Study Type: interventional
• Target: 650
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Dental Caries; Early Childhood Caries

Keywords

Early Childhood Caries; Randomized clinical trial; Motivational Interviewing

Outcome Measures

Primary Outcomes (1)

• 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.

  three years

Study Arms (2)

Motivational Interview

EXPERIMENTAL

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.

Behavioral: Motivational Interview

Traditional health education

ACTIVE COMPARATOR

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.

Other: Traditional health education

Interventions

Motivational Interview BEHAVIORAL

Motivational Interview

Traditional health education OTHER

Traditional health education

Eligibility Criteria

• Age: 12 Months - 14 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Nossa Senhora da Conceicao: lead
• Federal University of Rio Grande do Sul: collaborator

Related Publications (1)

• 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.

  PMID: 29885752 DERIVED

MeSH Terms

Conditions

Dental Caries

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dentist

Study Record Dates

• First Submitted: October 14, 2015
• First Posted: October 19, 2015
• Study Start: January 1, 2014
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09