Dental Caries in ChildrenNCT01205971
Tooth Smart Healthy Start: Oral Health Advocates in Public Housing
A study testing Motivational Interviewing and Dental Preventive Services in people with Dental Caries in Children, run by Boston University at 1 site in United States.
Trial summary
Dental caries is the most common chronic disease of childhood and is increasing in prevalence in children 2-5 years old. Racial and ethnic minority groups as well as economically disadvantaged individuals are affected the most by this health outcome. Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Caries in Children
- What is being tested?
- Motivational Interviewing and Dental Preventive Services
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,842 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to 23 Dec 2016
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- be living in participating public housing sites
- have one or more children 0-5 years old or be in their third trimester of pregnancy
- plan to live in their current housing development for the ensuing 24 months
- be able and willing to provide informed consent
Who cannot join
- caregivers unable to communicate orally in English or Spanish
- subject child has a known systemic disease associated with abnormal tooth development or abnormal oral health status such as cleft lip or palate, Burkett's lymphoma, osteogenesis imperfecta, ameliogenesis imperfecta, or dentinogenesis imperfecta
- children who have a known allergy to fluoride varnish and its components
- caregivers less than 15 years old
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Oral Health Advocates in Public Housing
Dental caries is the most common chronic disease of childhood and is increasing in prevalence in children 2-5 years old. Racial and ethnic minority groups as well as economically disadvantaged individuals are affected the most by this health outcome. This study will test if a community-based multimodal intervention will reduce 2-year incidence of early childhood caries (ECC) in children aged 0-5 living in public housing developments. The intervention combines the components of motivational interviewing (counseling) delivered by dental health advocates, fluoride varnish application, oral health assessment and referral. The investigators hypothesize that the multimodal intervention with motivational interviewing will reduce ECC behavioral risk factors thereby leading to a reduction of ECC incidence when compared to fluoride varnish application, written oral health education materials and oral health assessment and referral.
Read the detailed description
Dental caries is the most common, chronic disease of childhood, is increasing in prevalence, and disproportionately affects individuals who are financially disadvantaged and from racial and ethnic minority groups. Given the chronic nature of dental caries, clinically based preventive and restorative care alone will likely be inadequate to decrease disparities in early childhood caries (ECC) prevalence. We posit that a multimodal community-based approach, which addresses the chronic, infectious and multifactorial nature of dental caries, will be more effective than either behavioral counseling and the chemotherapeutic effects of fluoride alone. In addition to counseling and fluoride application, a successful community-based multimodal intervention will also need to equip caregivers with the skills to become involved in the prevention and management of ECC.
This group randomized clinical trial will test if a community-based multimodal intervention will reduce the 2-year ECC incidence of children aged 0-5 living in public housing developments. The intervention combines evidence based components and a unique delivery setting (public housing). We hypothesize that the multimodal intervention comprised of oral health assessment and feedback, fluoride varnish application, and motivational interviewing delivered by Dental Health Advocates (trained public housing residents) can reduce incidence of ECC in 0-5 year olds compared with a control group that receives oral health assessment and feedback, fluoride varnish application, and written oral health education materials.
This study is well poised for dissemination. Ultimately, this work could be disseminated nationwide and could potentially improve the oral health of over 500,000 family households and over 1 million children living in public housing.
- Conditions
- Dental Caries in Children
- Being tested
- Motivational Interviewing, Dental Preventive Services
- Keywords
- Motivational interviewing, Community-based multimodal intervention, Dental Health Advocates, Prevention of ECC, Randomized clinical trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational InterviewingBehavioural
Motivational interviewing is delivered by trained public housing residents, every 3 months for a total of 8 sessions over 24 months.
Dental Preventive ServicesBehavioural
Written oral health educational materials
| Study group | Role | What they receive |
|---|---|---|
| Motivational Interviewing | Experimental | Motivational Interviewing to reduce caregiver risk factors for early childhood caries in their children is delivered by Dental Health Advocates (trained public housing residents) in combination with fluoride varnish applications, oral health assessments and referrals for children. Receives: Behavioral: Motivational Interviewing |
| Dental Preventive Services | Active comparator | Fluoride varnish applications, written oral health educational materials regarding early childhood caries prevention, oral health assessments and referrals. Receives: Behavioral: Dental Preventive Services |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dental caries incidence
Measured: 24 months
Secondary outcomes (1)
Behavioral risk factors for early childhood caries
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2010 (estimated)
- Study startJan 2011
- Primary completion23 Dec 2016
- Study completion23 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Dental Caries in ChildrenStudies of the same condition, open and under way.
- More trials run by Boston UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2,842 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Responsible party
- Principal investigator, Michelle Henshaw, Boston University
- Investigators
- Michelle M Henshaw, DDS, MPH, Principal investigator, Boston UniversityBelinda Borrelli, PhD, Principal investigator, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01205971
- Sponsor's protocol ID
- H-27749
- Other IDs
- U54DE019275
- Status last verified
- Feb 2018
- First submitted
- 19 Sep 2010
- Last updated
- 13 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Researchers can make a data request through the EC4 website oralhealthdisparities.ucsf.edu
Publications
Henshaw MM, Borrelli B, Gregorich SE, Heaton B, Tooley EM, Santo W, Cheng NF, Rasmussen M, Helman S, Shain S, Garcia RI. Randomized Trial of Motivational Interviewing to Prevent Early Childhood Caries in Public Housing. JDR Clin Trans Res. 2018 Oct;3(4):353-365. doi: 10.1177/2380084418794377. Epub 2018 Aug 22.
PubMed 30238060Albino J, Tiwari T, Gansky SA, Henshaw MM, Barker JC, Brega AG, Gregorich SE, Heaton B, Batliner TS, Borrelli B, Geltman P, Kressin NR, Weintraub JA, Finlayson TL, Garcia RI; Early Childhood Caries Collaborating Centers. The basic research factors questionnaire for studying early childhood caries. BMC Oral Health. 2017 May 19;17(1):83. doi: 10.1186/s12903-017-0374-5.
PubMed 28526003
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Health Advocates in Public Housing
- ClinicalTrials.gov ID
- NCT01205971
- Acronym / sponsor ID
- H-27749
- Conditions
- Dental Caries in Children
- Keywords
- Motivational interviewing, Community-based multimodal intervention, Dental Health Advocates, Prevention of ECC, Randomized clinical trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,842 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Study start
- Jan 2011 (actual)
- Primary completion
- 23 Dec 2016 (actual)
- Study completion
- 23 Dec 2016 (actual)
- First posted
- 21 Sep 2010 (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.
Dental caries is the most common chronic disease of childhood and is increasing in prevalence in children 2-5 years old. Racial and ethnic minority groups as well as economically disadvantaged individuals are affected the most by this health outcome. This study will test if a community-based multimodal intervention will reduce 2-year incidence of early childhood caries (ECC) in children aged 0-5 living in public housing developments. The intervention combines the components of motivational interviewing (counseling) delivered by dental health advocates, fluoride varnish application, oral health assessment and referral. The investigators hypothesize that the multimodal intervention with motivational interviewing will reduce ECC behavioral risk factors thereby leading to a reduction of ECC incidence when compared to fluoride varnish application, written oral health education materials and oral health assessment and referral.
Detailed description
Dental caries is the most common, chronic disease of childhood, is increasing in prevalence, and disproportionately affects individuals who are financially disadvantaged and from racial and ethnic minority groups. Given the chronic nature of dental caries, clinically based preventive and restorative care alone will likely be inadequate to decrease disparities in early childhood caries (ECC) prevalence. We posit that a multimodal community-based approach, which addresses the chronic, infectious and multifactorial nature of dental caries, will be more effective than either behavioral counseling and the chemotherapeutic effects of fluoride alone. In addition to counseling and fluoride application, a successful community-based multimodal intervention will also need to equip caregivers with the skills to become involved in the prevention and management of ECC.
This group randomized clinical trial will test if a community-based multimodal intervention will reduce the 2-year ECC incidence of children aged 0-5 living in public housing developments. The intervention combines evidence based components and a unique delivery setting (public housing). We hypothesize that the multimodal intervention comprised of oral health assessment and feedback, fluoride varnish application, and motivational interviewing delivered by Dental Health Advocates (trained public housing residents) can reduce incidence of ECC in 0-5 year olds compared with a control group that receives oral health assessment and feedback, fluoride varnish application, and written oral health education materials.
This study is well poised for dissemination. Ultimately, this work could be disseminated nationwide and could potentially improve the oral health of over 500,000 family households and over 1 million children living in public housing.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Motivational Interviewing | Experimental | Behavioral: Motivational InterviewingMotivational Interviewing to reduce caregiver risk factors for early childhood caries in their children is delivered by Dental Health Advocates (trained public housing residents) in combination with fluoride varnish applications, oral health assessments and referrals for children. |
| Dental Preventive Services | Active comparator | Behavioral: Dental Preventive ServicesFluoride varnish applications, written oral health educational materials regarding early childhood caries prevention, oral health assessments and referrals. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- be living in participating public housing sites
- have one or more children 0-5 years old or be in their third trimester of pregnancy
- plan to live in their current housing development for the ensuing 24 months
- be able and willing to provide informed consent
Key exclusion criteria (4 listed)
- caregivers unable to communicate orally in English or Spanish
- subject child has a known systemic disease associated with abnormal tooth development or abnormal oral health status such as cleft lip or palate, Burkett's lymphoma, osteogenesis imperfecta, ameliogenesis imperfecta, or dentinogenesis imperfecta
- children who have a known allergy to fluoride varnish and its components
- caregivers less than 15 years old
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 InterviewingMotivational interviewing is delivered by trained public housing residents, every 3 months for a total of 8 sessions over 24 months. | Behavioural | Motivational Interviewing |
| Dental Preventive ServicesWritten oral health educational materials | Behavioural | Dental Preventive Services |
Primary outcome
Dental caries incidence
Time frame: 24 months
1 secondary outcome
Behavioral risk factors for early childhood caries
Time frame: 24 months
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 13 Feb 2018.
- Derived from this study: PubMed 30238060Henshaw MM, Borrelli B, Gregorich SE, Heaton B, Tooley EM, Santo W, Cheng NF, Rasmussen M, Helman S, Shain S, Garcia RI. Randomized Trial of Motivational Interviewing to Prevent Early Childhood Caries in Public Housing. JDR Clin Trans Res. 2018 Oct;3(4):353-365. doi: 10.1177/2380084418794377. Epub 2018 Aug 22.
- Derived from this study: PubMed 28526003Albino J, Tiwari T, Gansky SA, Henshaw MM, Barker JC, Brega AG, Gregorich SE, Heaton B, Batliner TS, Borrelli B, Geltman P, Kressin NR, Weintraub JA, Finlayson TL, Garcia RI; Early Childhood Caries Collaborating Centers. The basic research factors questionnaire for studying early childhood caries. BMC Oral Health. 2017 May 19;17(1):83. doi: 10.1186/s12903-017-0374-5.
- Northeast Center for Research to Evaluate and Eliminate Dental DisparitiesLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Researchers can make a data request through the EC4 website oralhealthdisparities.ucsf.edu
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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.
Michelle M Henshaw, DDS, MPH principal investigator
Boston University
Belinda Borrelli, PhD principal investigator
Brown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational Interviewing and Dental Preventive Services in people with Dental Caries in Children, run by Boston 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 4 inclusion and 4 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 13 Feb 2018. 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.
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.
What does the primary outcome measure?
Dental caries incidence (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01205971, which also lists 2 linked publications.
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 13 Feb 2018.