MULTISITE CLINICAL TRIAL OF RIGID- VS. WIRE-FIXATION

Project: Research project

Project Details

Description

During the past 25 years significant advances have been made in correcting
dentofacial malrelations through a combination of surgery and orthodontics.
These interventions have become relatively common; however, there are
controversies regarding the various procedures. Current knowledge is based
primarily upon case reports and retrospective comparisons. There have been
no large randomized clinical trials to establish efficacy, to determine
risk factors, nor to establish the cost-effectiveness of specific
procedures. The objective of this research is to compare the efficacy and
cost-effectiveness of the two most commonly used surgical stabilization
procedures--rigid fixation and wire fixation--in the most common
orthognathic procedure--mandibular advancement. A secondary objective is to
identify patient risk factors and describe the complications associated
with these two procedures. These objectives will be accomplished through a
randomized clinical trial involving three sites: The University of Texas
Health Science Center at San Antonio, Emory University in Atlanta, and the
University of Florida at Gainesville. One hundred and eighty patients
referred by orthodontists for surgical correction of a Class II dentofacial
malrelation will be randomly assigned to receive either rigid or wire
fixation. The two patient groups will be assessed before surgery and at
five post-surgical intervals over a two-year follow-up period. Assessments
will be made of stability, oral function, neurosensory loss, TM signs and
symptoms, quality of life, patient satisfaction, and cost-effectiveness.
These outcome assessments will be accomplished and scored by evaluators who
are blind to the treatment. Specific hypotheses will be tested between
groups and the use of standardized assessments will allow us to describe
and compare our patients pre- and post-surgery. The trial will have
statistical power greater than 0.90 to detect clinically significant
differences between the two procedures. The trial includes rules for
stopping and interim analyses. A trial review and safety committee will
evaluate progress at yearly intervals over the planned five-year study. The
knowledge gained from this clinical trial will allow clinicians to
appropriately advise patients about the relative efficacy, complications,
and cost-effectiveness of these common orthognathic procedures. The results
will also provide the necessary knowledge to identify patients at risk for
complications with either surgical technique. The long-term objective is to
improve oral health care and overall quality of life of persons having
dentofacial malrelations.
StatusFinished
Effective start/end date7/1/9012/31/00

Funding

  • National Institutes of Health
  • National Institutes of Health
  • National Institutes of Health
  • National Institutes of Health: $68,198.00
  • National Institutes of Health
  • National Institutes of Health
  • National Institutes of Health
  • National Institutes of Health: $252,757.00
  • National Institutes of Health
  • National Institutes of Health
  • National Institutes of Health
  • National Institutes of Health
  • National Institutes of Health
  • National Institutes of Health: $257,534.00
  • National Institutes of Health

ASJC

  • Medicine(all)
  • Dentistry(all)

Fingerprint Explore the research topics touched on by this project. These labels are generated based on the underlying awards/grants. Together they form a unique fingerprint.