Early Childhood Dental CariesIMB-RCTNCT00464009
Development and Evaluation of a Medical Intervention for Early Childhood Caries
A study testing Continuing medical education in people with Early Childhood Dental Caries, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
This study aimed to evaluate the effect of three forms of continuing medical education (CME) on provision of preventive dental services to Medicaid-enrolled children by medical personnel in primary care physician offices. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Early Childhood Dental Caries
- What is being tested?
- Continuing medical education
- 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
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2001to Nov 2007
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- pediatric or family physician Medicaid practice in North Carolina
Who cannot join
- participation in related pilot study
Trial locations and contacts
1 site in 1 country.
United States1 site
UNC-CH, School of Public Health
Chapel Hill, North Carolina, 27955
About this study
This study aimed to evaluate the effect of three forms of continuing medical education (CME) on provision of preventive dental services to Medicaid-enrolled children by medical personnel in primary care physician offices.
Read the detailed description
Practice-based, randomized controlled trial. Setting: 1,400 pediatric and family physician practices in North Carolina providing care to an estimated 240,000 Medicaid-eligible children aged 0-3 years. Interventions: Group A practices (n=39) received didactic training and course materials in oral health screening, referral, counseling and application of fluoride varnish. Group B practices (n=41) received the same as Group A and were offered weekly conference calls providing advice and support. Group C practices (n=41) received the same as Group B and were offered in-office visit providing hands-on advice and support. Outcome measures were computed from reimbursement claims submitted to NC Division of Medical Assistance. Primary outcome measure: rate of preventive dental services provision per 100 well-child visits. Secondary outcome measure: % of practices providing 20 or more preventive dental visits.
- Conditions
- Early Childhood Dental Caries
- Being tested
- Continuing medical education
- Keywords
- Early childhood caries - ECC, Prevention, Continuing medical education, Randomized controlled trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuing medical educationBehavioural
Group A practices took part in a 90 minute lecture with slides, case-based presentations and discussions of the clinical interventions, instruction in children's dental development, common dental diseases and prevention, screening, referral, counseling and fluoride varnish application. Group B practices received the same as group A and additionally were offered support through telephone conference calls using "learning collaborative" methods where staff receive ongoing support from CME instructors and learn from one another as they begin to implement systems for preventive care in their practices. The conference calls were moderated by research staff with clinical expertise in primary health care who had assisted in other interventions among NC pediatric and family medicine offices. Group C received the same intervention as Group B and were offered additional in-office support for implementation of preventive dental procedures provided by a dental hygienist.
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Group A practices (n=39) received didactic training and course materials in oral health screening, referral, counseling and application of fluoride varnish. Receives: Behavioral: Continuing medical education |
| B | Active comparator | Group B practices (n=41) received the same as Group A and were offered weekly conference calls providing advice and support. Receives: Behavioral: Continuing medical education |
| C | Active comparator | Group C practices (n=41) received the same as Group B and were also offered in-office follow-up visits providing hands-on advice and support. Receives: Behavioral: Continuing medical education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of preventive dental services provision per 100 well-child visits.
Measured: One year following initial training.
Secondary outcomes (1)
Percent of practices providing 20 or more preventive dental visits.
Measured: One year following initial training.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2007 (estimated)
- Study startFeb 2001
- Primary completionApr 2002
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Early Childhood Dental CariesStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Investigators
- Richard G Rozier, DDS, Principal investigator, UNC-CH, School of Public Health, Department of Health Policy and Administration
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00464009
- Sponsor's protocol ID
- 11-P-91251/4-02
- Acronym
- IMB-RCT
- Status last verified
- Sep 2009
- First submitted
- 19 Apr 2007
- Last updated
- 29 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Quinonez RB, Pahel BT, Rozier RG, Stearns SC. Follow-up preventive dental visits for Medicaid-enrolled children in the medical office. J Public Health Dent. 2008 Summer;68(3):131-8. doi: 10.1111/j.1752-7325.2007.00055.x.
PubMed 18179471Rozier RG, Sutton BK, Bawden JW, Haupt K, Slade GD, King RS. Prevention of early childhood caries in North Carolina medical practices: implications for research and practice. J Dent Educ. 2003 Aug;67(8):876-85.
PubMed 12959161Slade GD, Rozier RG, Zeldin LP, Margolis PA. Training pediatric health care providers in prevention of dental decay: results from a randomized controlled trial. BMC Health Serv Res. 2007 Nov 2;7:176. doi: 10.1186/1472-6963-7-176.
PubMed 17980021Rozier RG, Slade GD, Zeldin LP, Wang H. Parents' satisfaction with preventive dental care for young children provided by nondental primary care providers. Pediatr Dent. 2005 Jul-Aug;27(4):313-22.
PubMed 16317972
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of a Medical Intervention for Early Childhood Caries
- ClinicalTrials.gov ID
- NCT00464009
- Acronym / sponsor ID
- IMB-RCT / 11-P-91251/4-02
- Conditions
- Early Childhood Dental Caries
- Keywords
- Early childhood caries - ECC, Prevention, Continuing medical education, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- Feb 2001
- Primary completion
- Apr 2002 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 20 Apr 2007 (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.
This study aimed to evaluate the effect of three forms of continuing medical education (CME) on provision of preventive dental services to Medicaid-enrolled children by medical personnel in primary care physician offices.
Detailed description
Practice-based, randomized controlled trial. Setting: 1,400 pediatric and family physician practices in North Carolina providing care to an estimated 240,000 Medicaid-eligible children aged 0-3 years. Interventions: Group A practices (n=39) received didactic training and course materials in oral health screening, referral, counseling and application of fluoride varnish. Group B practices (n=41) received the same as Group A and were offered weekly conference calls providing advice and support. Group C practices (n=41) received the same as Group B and were offered in-office visit providing hands-on advice and support. Outcome measures were computed from reimbursement claims submitted to NC Division of Medical Assistance. Primary outcome measure: rate of preventive dental services provision per 100 well-child visits. Secondary outcome measure: % of practices providing 20 or more preventive dental visits.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Behavioral: Continuing medical educationGroup A practices (n=39) received didactic training and course materials in oral health screening, referral, counseling and application of fluoride varnish. |
| B | Active comparator | Behavioral: Continuing medical educationGroup B practices (n=41) received the same as Group A and were offered weekly conference calls providing advice and support. |
| C | Active comparator | Behavioral: Continuing medical educationGroup C practices (n=41) received the same as Group B and were also offered in-office follow-up visits providing hands-on advice and support. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- pediatric or family physician Medicaid practice in North Carolina
Key exclusion criteria (1 listed)
- participation in related pilot 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 |
|---|---|---|
| Continuing medical educationGroup A practices took part in a 90 minute lecture with slides, case-based presentations and discussions of the clinical interventions, instruction in children's dental development, common dental diseases and prevention, screening, referral, counseling and fluoride varnish application. Group B practices received the same as group A and additionally were offered support through telephone conference calls using "learning collaborative" methods where staff receive ongoing support from CME instructors and learn from one another as they begin to implement systems for preventive care in their practices. The conference calls were moderated by research staff with clinical expertise in primary health care who had assisted in other interventions among NC pediatric and family medicine offices. Group C received the same intervention as Group B and were offered additional in-office support for implementation of preventive dental procedures provided by a dental hygienist. | Behavioural | A, B, C |
Primary outcome
Rate of preventive dental services provision per 100 well-child visits.
Time frame: One year following initial training.
1 secondary outcome
Percent of practices providing 20 or more preventive dental visits.
Time frame: One year following initial training.
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 29 Jan 2010.
- Background: PubMed 18179471Quinonez RB, Pahel BT, Rozier RG, Stearns SC. Follow-up preventive dental visits for Medicaid-enrolled children in the medical office. J Public Health Dent. 2008 Summer;68(3):131-8. doi: 10.1111/j.1752-7325.2007.00055.x.
- Results publication: PubMed 12959161Rozier RG, Sutton BK, Bawden JW, Haupt K, Slade GD, King RS. Prevention of early childhood caries in North Carolina medical practices: implications for research and practice. J Dent Educ. 2003 Aug;67(8):876-85.
- Results publication: PubMed 17980021Slade GD, Rozier RG, Zeldin LP, Margolis PA. Training pediatric health care providers in prevention of dental decay: results from a randomized controlled trial. BMC Health Serv Res. 2007 Nov 2;7:176. doi: 10.1186/1472-6963-7-176.
- Results publication: PubMed 16317972Rozier RG, Slade GD, Zeldin LP, Wang H. Parents' satisfaction with preventive dental care for young children provided by nondental primary care providers. Pediatr Dent. 2005 Jul-Aug;27(4):313-22.
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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.
Richard G Rozier, DDS principal investigator
UNC-CH, School of Public Health, Department of Health Policy and Administration
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuing medical education in people with Early Childhood Dental Caries, run by University of North Carolina, Chapel Hill 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 1 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 29 Jan 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.
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?
Rate of preventive dental services provision per 100 well-child visits. (time frame: One year following initial training.). 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 NCT00464009, which also lists 4 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 29 Jan 2010.