Early Orthodontic Intervention Under Medicaid
Primary Purpose
Malocclusion
Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
interceptive orthodontic treatments
Sponsored by
About this trial
This is an interventional treatment trial for Malocclusion
Eligibility 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
Sites / Locations
- Odessa Brown Children's Clinic
Arms of the Study
Arm 1
Arm Type
Active Comparator
Arm Label
1
Arm Description
Medicaid patients with medically necessary malocclusions treated during the mixed dentition with limited goals followed by observation
Outcomes
Primary Outcome Measures
Peer Assessment Rating
Secondary Outcome Measures
Full Information
NCT ID
NCT00067379
First Posted
August 15, 2003
Last Updated
June 9, 2010
Sponsor
University of Washington
Collaborators
National Institute of Dental and Craniofacial Research (NIDCR), Northwest and Alaska Center on Oral Health Disparities, Washington State Department of Social and Health Services, Seattle Children's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00067379
Brief Title
Early Orthodontic Intervention Under Medicaid
Official Title
Early Orthodontic Intervention Under Medicaid
Study Type
Interventional
2. Study Status
Record Verification Date
June 2010
Overall Recruitment Status
Unknown status
Study Start Date
April 2003 (undefined)
Primary Completion Date
June 2009 (Anticipated)
Study Completion Date
June 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
University of Washington
Collaborators
National Institute of Dental and Craniofacial Research (NIDCR), Northwest and Alaska Center on Oral Health Disparities, Washington State Department of Social and Health Services, Seattle Children's Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malocclusion
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Medicaid patients with medically necessary malocclusions treated during the mixed dentition with limited goals followed by observation
Intervention Type
Procedure
Intervention Name(s)
interceptive orthodontic treatments
Intervention Description
orthodontic procedures
Primary Outcome Measure Information:
Title
Peer Assessment Rating
Time Frame
Pre-study, post - early treatment or observation, post full treatment or observation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory J King, DDS
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
Odessa Brown Children's Clinic
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
22699670
Citation
King GJ, Spiekerman CF, Greenlee GM, Huang GJ. Randomized clinical trial of interceptive and comprehensive orthodontics. J Dent Res. 2012 Jul;91(7 Suppl):59S-64S. doi: 10.1177/0022034512448663.
Results Reference
derived
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Early Orthodontic Intervention Under Medicaid
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