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OpenTrials
Completed

NCT Number: NCT00464009

Development and Evaluation of a Medical Intervention for Early Childhood Caries

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.

Completed

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UNC-CH, School of Public Health

Chapel Hill, North Carolina, 27955, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • pediatric or family physician Medicaid practice in North Carolina

Exclusion criteria

  • participation in related pilot study

Treatment and study plan

Continuing Medical Education

Behavioral

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.

Primary outcomes

  1. Rate of preventive dental services provision per 100 well-child visits.

    Time frame: One year following initial training.

Secondary outcomes

  1. Percent of practices providing 20 or more preventive dental visits.

    Time frame: One year following initial training.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Registry information

Acronym: IMB-RCT

Important dates

Study start
2001
Primary completion
2002
Study completion
2007
First posted
Apr 20, 2007
Registry last updated
Jan 29, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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