Dental CariesPhase 3NCT00103493
Oral Health Education Program
A Phase 3 study testing Motivational interviewing and Targeted DVD-based educational program in people with Dental Caries and Oral Hygiene, run by Temple University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 15 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries, Oral Hygiene, Oral Health
- What is being tested?
- Motivational interviewing and Targeted DVD-based educational program
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,021 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2004to Aug 2005
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- No family who is eligible was excluded from this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of a Tailored Oral Health Education Program
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.
Read the 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.
- Conditions
- Dental Caries, Oral Hygiene, Oral Health, Dental Health
- Being tested
- Motivational interviewing, Targeted DVD-based educational program
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational interviewingBehavioural
Targeted DVD-based educational programBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2005 (estimated)
- Study startOct 2004
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 1,021 participants (actual)
Sponsor and investigators
- Lead sponsor
- Temple University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR), University of Michigan, Delta Dental Fund of Michigan
- Investigators
- Amid Ismail, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00103493
- Sponsor's protocol ID
- NIDCR-14261
- Other IDs
- U54DE014261
- Status last verified
- Jul 2009
- First submitted
- 9 Feb 2005
- Last updated
- 22 Nov 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Tailored Oral Health Education Program
- ClinicalTrials.gov ID
- NCT00103493
- Acronym / sponsor ID
- NIDCR-14261
- Conditions
- Dental Caries, Oral Hygiene, Oral Health, Dental Health
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,021 participants (actual)
- Lead sponsor
- Temple UniversityUniversity, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR), University of Michigan, Delta Dental Fund of Michigan
- Study start
- Oct 2004
- Study completion
- Aug 2005 (actual)
- First posted
- 10 Feb 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 15 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- No family who is eligible was excluded from this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivational interviewing | Behavioural | – |
| Targeted DVD-based educational program | Behavioural | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amid Ismail principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Motivational interviewing and Targeted DVD-based educational program in people with Dental Caries and Oral Hygiene, run by Temple University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2010.