NCT00067379

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Apr 2003

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2003

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 15, 2003

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 19, 2003

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

June 10, 2010

Status Verified

June 1, 2010

Enrollment Period

6.2 years

First QC Date

August 15, 2003

Last Update Submit

June 9, 2010

Conditions

Malocclusion

Outcome Measures

Primary Outcomes (1)

  • Peer Assessment Rating

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

Study Arms (1)

1

ACTIVE COMPARATOR

Medicaid patients with medically necessary malocclusions treated during the mixed dentition with limited goals followed by observation

Procedure: interceptive orthodontic treatments

Interventions

interceptive orthodontic treatmentsPROCEDURE

orthodontic procedures

1

Eligibility Criteria

Age8 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Odessa Brown Children's Clinic

Seattle, Washington, 98122, United States

Location

Related Publications (1)

  • 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.

    PMID: 22699670DERIVED

MeSH Terms

Conditions

Malocclusion

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Study Officials

  • Gregory J King, DDS

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 15, 2003

First Posted

August 19, 2003

Study Start

April 1, 2003

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

June 10, 2010

Record last verified: 2010-06

Locations

US(1)