Oral Health Education Program

This study has been completed.
Sponsor:
Collaborators:
University of Michigan
Delta Dental Fund of Michigan
Information provided by:
Temple University
ClinicalTrials.gov Identifier:
NCT00103493
First received: February 9, 2005
Last updated: November 19, 2010
Last verified: July 2009
  Purpose

The purpose of this study is to evaluate whether an oral health education program that is tailored to caregivers' understanding and acceptance of information on how to prevent tooth decay will lead to improvement in behaviors conducive to good oral health and reduction in tooth decay in his or her children.


Condition Intervention Phase
Dental Caries
Oral Hygiene
Oral Health
Dental Health
Behavioral: Motivational interviewing
Behavioral: Targeted DVD-based educational program
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Official Title: Efficacy of a Tailored Oral Health Education Program

Resource links provided by NLM:


Further study details as provided by Temple University:

Enrollment: 1021
Study Start Date: October 2004
Study Completion Date: August 2005
Detailed Description:

The Detroit Dental Health Project (DDHP) is a seven-year research study designed to identify the determinants of variation in prevalence and incidence of dental caries among low-income African-American children in Detroit. The children were randomly selected from housing units located in the lowest income areas (less than 250% of the poverty line). After over a year of preparation and testing, the DDHP listed over 18,000 housing and non-housing units in 118 randomly selected low-income neighborhoods in Detroit. A total of 12,000 housing units were randomly sampled and contacted over a period of one year (September 2001 - August 2002) in order to recruit a representative sample of African American children. Field interviewers contacted the selected housing units. The recruitment process located and scheduled around 1,400 families to visit the Dental Assessment Center (DAC). Of those, 1,021 visited the DAC and completed examinations and interviews (Phase I).

The long-term objective of this project is to develop an effective multi-component tailored/targeted behavioral intervention to promote and maintain good oral health and prevent oral diseases among low-income children. To achieve this, a multimedia-based multi-level intervention has been designed to be easy to use and easy to disseminate for large-scale use.

The efficacy of the Multi-Component Tailored/Targeted Intervention that will be delivered using motivational interviewing and a targeted educational video designed and produced for the specific population in comparison with the non-tailored health education (targeted educational video only - control group) will be tested in a randomized controlled trial. In Phase II of the Detroit Dental Health Project, the 1,021 low-income African Americans recruited will be randomly assigned to one of the two intervention groups. A dental examination will provide the baseline measurement and changes in the outcomes will be assessed in the follow-up examination after two years. Participants in the control and intervention groups will complete a questionnaire about their oral health and related behaviors. Participants in the control group will receive standard oral hygiene and caries risk counseling using only the educational video without any motivational interviewing (equivalent to a counseling session conducted by a dentist).

The 1,021 families have been randomized using a list of randomly generated numbers. The allocation of the assignment is being concealed from the analysis team and the examining dentist. After each session, the participants receive a "recipe" for oral health with a picture of their child. The control group participants receive a standard plan; whereas the caregivers in the intervention group receive the specific plan they have developed with the motivational interviewer.

After the intervention/control session, the participants are being followed by telephone contact to review the progress in oral health behaviors and answer questions. Follow-up questionnaires will be administered after 2-4 weeks, at 6 months, and 2 years after the intervention/control session.

  Eligibility

Ages Eligible for Study:   15 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All participants have been randomly selected from 39 Census Tracts (CTs) in the city of Detroit. The tracts were selected based on household income using 2000 Census Data.
  • Participants should live in one of the randomly selected dwellings in the selected CTs; have a child or children less than 6 years old at the time of recruitment in 2002-2003; and have a total family income of less than 250% percentile of the federal poverty line.

Exclusion Criteria:

  • No family who is eligible was excluded from this study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00103493

Locations
United States, Michigan
Dental Assessment Center
Detroit,, Michigan, United States, 48215
Sponsors and Collaborators
Temple University
University of Michigan
Delta Dental Fund of Michigan
Investigators
Principal Investigator: Amid Ismail University of Michigan
  More Information

No publications provided

Responsible Party: Amid Ismail, Principal Investigator, Temple University
ClinicalTrials.gov Identifier: NCT00103493     History of Changes
Other Study ID Numbers: NIDCR-14261, U54DE014261
Study First Received: February 9, 2005
Last Updated: November 19, 2010
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on July 23, 2014