Early Orthodontic Intervention Under Medicaid

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by University of Washington.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Northwest and Alaska Center on Oral Health Disparities
Washington State Department of Social and Health Services
Seattle Children's Hospital
Information provided by:
University of Washington
ClinicalTrials.gov Identifier:
NCT00067379
First received: August 15, 2003
Last updated: June 9, 2010
Last verified: June 2010
  Purpose

The primary objective of this study is to examine the usefulness of early orthodontic intervention as a means of increasing access to orthodontic services for children of low-income families.


Condition Intervention Phase
Malocclusion
Procedure: interceptive orthodontic treatments
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Early Orthodontic Intervention Under Medicaid

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Peer Assessment Rating [ Time Frame: Pre-study, post - early treatment or observation, post full treatment or observation ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: April 2003
Estimated Study Completion Date: June 2009
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Medicaid patients with medically necessary malocclusions treated during the mixed dentition with limited goals followed by observation
Procedure: interceptive orthodontic treatments
orthodontic procedures

Detailed Description:

Orthodontic treatment has become a widely accepted procedure in dentistry. The benefits include improved oral health, function, esthetics and quality of life. Significant disparities exist among income strata regarding access to orthodontic services. The sources of these disparities are complex and may reflect differences in the disease prevalence, gender, cultural biases, perception of problems by this population, economic imperatives and negative perceptions of these patients by orthodontists. The primary objective of this study is to examine the usefulness of early orthodontic intervention as a means of increasing access to orthodontic services for children of low-income families.

Aim 1. To compare orthodontic outcomes, facial body image, and quality of life between Medicaid participants who receive early orthodontic treatment and those who do not. 1.a To compare the level of understanding and compliance between early treatment subjects given information about the goals, risks and benefits of the planned treatment one-on-one by an orthodontist, with subjects who also use an interactive CD-ROM to provide this information. This will be referred to as the Informed Consent Study and should not be confused with the routine informed consenting process used to enroll subjects into the overall study.Aim 2. To compare orthodontic outcomes, facial body image, and quality of life between Medicaid-funded and private-pay patients who receive full orthodontic treatment at adolescence.Aim 3. To compare orthodontic outcomes, facial body image, and quality of life between Medicaid-funded patients who receive early orthodontic treatment only and Medicaid-funded participants who receive full orthodontic treatment at adolescence. Relationship of this project with the Disparity Center theme. Two of the goals of the Northwest and Alaska Center for Oral Health Disparity are met by this study. The first is to conduct clinical research to evaluate the efficacy of interventions to prevent and treat oral diseases and conditions in children. The second is to develop community-based research that translates existing knowledge and new information regarding children and their caretakers into new technologies and interventions that hold promise for reducing disparities. Today, children of low-income families have very limited access to orthodontic treatment. We also know that some relatively simple interventions done during the mixed dentition can be effective at reducing the severity of malocclusion. This study is designed to examine how effective these early orthodontic interventions are in a Medicaid population. It will also examine how outcomes from early treatment in Medicaid patients compare to the more complex approach of complete orthodontic treatment in the permanent dentition. Many orthodontists perceive that Medicaid patients are at risk for poor outcomes, and limit access as a consequence. The follow-up component of this study will address this issue by making a comparison between Medicaid and private-pay patients treated in similar environments. We expect that significantly greater access to orthodontic services could be provided for Medicaid patients by the more widespread use of simpler, more timely interventions. This study will provide data on the trade-off between simple, timely partial treatments, versus complete full treatments. In response to the second theme of the Disparity Center, the use of interactive CD-ROMs that provide treatment information at the comprehension level of young patients and their parents, and in a culturally appropriate manner, will be examined. We expect this approach will improve patient and parent understanding of the proposed treatment, as well as enhancing compliance with treatment procedures in order to assure successful outcomes.

  Eligibility

Ages Eligible for Study:   8 Years to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

"Inclusion Criteria:"

  • Enrolled in Medicaid
  • Fluency in English, Spanish, Vietnamese, Chinese, Somalian or Ethiopian
  • Acceptable malocclusion
  • Free of oral disease
  • Current immunizations and record of dental care
  • Acceptable oral hygiene
  • Anticipate living in the area for 4 years
  • Absence of craniofacial anomalies
  • Absence of unilateral posterior crossbite with facial asymmetry
  • No prior orthodontic treatment
  • Agree to be randomized to early orthodontic treatment or late full treatment
  • Signs assent/consent
  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: NCT00067379

Locations
United States, Washington
Odessa Brown Children's Clinic
Seattle, Washington, United States, 98122
Sponsors and Collaborators
University of Washington
Northwest and Alaska Center on Oral Health Disparities
Washington State Department of Social and Health Services
Seattle Children's Hospital
Investigators
Principal Investigator: Gregory J King, DDS University of Washington
  More Information

No publications provided

Responsible Party: Gregory King, DMD, PhD, University of Washington
ClinicalTrials.gov Identifier: NCT00067379     History of Changes
Other Study ID Numbers: NIDCR-142542, U54DE014254
Study First Received: August 15, 2003
Last Updated: June 9, 2010
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Malocclusion
Tooth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on July 22, 2014