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Early Orthodontic Intervention under Medicaid Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified medical advice, visits or professional assistance with a genuine dr.. We are not doctors. Always consult your mD about Early Orthodontic Intervention under Medicaid conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Early Orthodontic Intervention under Medicaid Clinical research trials and Early Orthodontic Intervention under Medicaid medical trials take place in many of places throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectiveness of new does drugs. The purpose of the studies / projects is to solve specific human healthcare questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to find cures for all varieties of conditions, like Early Orthodontic Intervention under Medicaid. Early Orthodontic Intervention under Medicaid Clinical Trials and other clinical trials allow for volunteers to have health treatment options before they are available to the masses. Many times the human subjects acquire professional assistance for free of charge, and sometimes they are compensated for their time. Occasionally there is a cost for a Early Orthodontic Intervention under Medicaid clinical trial. Test subjects typically obtain the finest healthcare available for their Early Orthodontic Intervention under Medicaid condition. Dangers are a reality, nevertheless, and might include additional or frequent doctor trips, medical dangers (possibly life-jeopardising), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials patients.
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Home > "E" Clinical Trials Conditions > Early Orthodontic Intervention under Medicaid  Early Orthodontic Intervention under Medicaid
Early Orthodontic Intervention under Medicaid
For Condition: Malocclusion
Status: Recruiting
Sponsor(s): National Institute of Dental and Craniofacial Research (NIDCR) , Northwest and Alaska Center on Oral Health Disparities,Washington State Department of Social and Health Services,Children's Hospital and Medical Center - Seattle
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Minimum Age/Maximum Age: 8 Years/11 Years
Genders: Both
Protocol Entry 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
Total Enrollment: 150
Location and Contact Information:
Overall Study Official:
GregoryKing, Principal Investigator, University of Washington
Odessa Brown Children's Clinic *Recruiting*
Seattle, Washington, 98122
United States
Recruiting Chris Delecki 206-329-7870
Additional Information:
Study ID Numbers: NIDCR-142542;
Study Start Date: April 2003
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00067379
Other Malocclusion Studies:
1. Early Orthodontic Intervention under Medicaid
Related Studies:
Other Malocclusion Clinical Trials
Other Washington Clinical Trials
Other Seattle Clinical Trials
Early Orthodontic Intervention under Medicaid
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