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MalocclusionPhase 1NCT00067379

Early Orthodontic Intervention Under Medicaid

A Phase 1 study testing interceptive orthodontic treatments in people with Malocclusion, run by University of Washington at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 8 to 11 years
Conditions the study is for
Malocclusion
What is being tested?
interceptive orthodontic treatments
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteUnited States
Study dates
Apr 2003to Jun 2009
Phase
Phase 1
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 8 to 11 years
  • All sexes
  • No healthy volunteers
  • Child

"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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Odessa Brown Children's Clinic

    Seattle, Washington, 98122

Other trials in United States

About this study

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.

Read the 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.

Conditions
Malocclusion
Being tested
interceptive orthodontic treatments
Medical subject headings
Malocclusion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • interceptive orthodontic treatmentsProcedure or surgery

    orthodontic procedures

Study groups in NCT00067379
Study groupRoleWhat they receive
1Active comparatorMedicaid patients with medically necessary malocclusions treated during the mixed dentition with limited goals followed by observation
Receives: Procedure: interceptive orthodontic treatments

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Peer Assessment Rating

    Measured: Pre-study, post - early treatment or observation, post full treatment or observation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Aug 2003 (estimated)
  2. Study startApr 2003
  3. Primary completionJun 2009 (estimated)
  4. Study completionJun 2009 (estimated)

Resources

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 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00067379
Sponsor's protocol ID
NIDCR-142542
Other IDs
U54DE014254
Status last verified
Jun 2010
First submitted
15 Aug 2003
Last updated
10 Jun 2010
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 22699670

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing interceptive orthodontic treatments in people with Malocclusion, run by University of Washington 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?

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: status not confirmed, as of the sponsor's last update on 10 Jun 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.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

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?

Peer Assessment Rating (time frame: Pre-study, post - early treatment or observation, post full treatment or observation). 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 NCT00067379, which also lists 1 linked publication.

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 10 Jun 2010; AzTrials last refreshed its copy on 4 Nov 2026.

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