Mandibular Injuries Clinical Trial
— MandOfficial title:
A Comparison of 2mm Plates and Screws With Larger Plates Ans Screws in the Treatment of Mandibular Fractures
Verified date | November 2013 |
Source | Emory University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Observational |
Patients who sustain a broken lower jaw have traditionally been treated in one of three
ways. The first involves having their teeth and jaws being wired together for a period of 4
to 6 weeks in order to allow the broken jaw to heal. The second and third ways involve a
surgical procedure that requires exposing the broken bones and stabilizing them with metal
plates and screws that allow the patient to be able to function relatively normally during
the healing period. One surgical method uses small plates and screws while the alternate
method uses large plates and screws. Currently there are two schools of thought with respect
to what plates and screws should be used. One group supports the use of large rigid plates
due to the increased strength of the plate. The use of the larger and stronger plates is the
principle behind the AO technique, which was originally developed in the 1970's in
Switzerland and is now the more popular technique in the USA. The other group supports the
use of smaller plates and screws which must be placed in certain anatomical positions to
allow the natural muscular forces that exist on the jaw to stabilize the break and
facilitate complete healing of the broken bone. This technique was developed in France by
Maxime Champy in the 1970's and is the standard of care throughout Australasia and parts of
Europe. This technique is simpler, quicker and cheaper. The need for patients to maintain a
diet with softer foods is considered by many to be important for success if the less rigid
and smaller plates are going to be used. Many critics of the Champy technique feel that less
compliant patient populations as might be seen in a county hospital make the technique less
readily suited to these populations. This is contrary to published data from Europe,
Australia and recently the USA.
The question of interest is whether the smaller plates and screws are equally as effective
in the treatment of broken lower jaws in an urban county hospital? If they are equally
effective, then is there any benefit in terms of fewer patient complications and decreased
health costs? If the smaller plates and screws are not adequate, then will a modification of
the original Champy technique improve their usefulness? Patients who present with a broken
lower jaw who require surgery will be treated in one of three ways. Some patients will be
treated with the larger plates and screws by an attending surgeon who routinely uses large
plates and screws for broken lower jaws. Another group of patients will be treated with the
smaller plates and screws using the Champy principles. A third group of patients will also
be treated with the smaller plates and screws but using a modification of the original
Champy technique that involves the use of additional small plates and screws for added
stability. Patients will then be followed over a three month period to evaluate for healing
of the broken jaw. The three techniques will be then be compared.
Larger plates/ screws and the smaller plates/ screws are both the standard of care. Regional
differences throughout the USA has continued to ensure differences of opinion with regard to
which technique is better although historically the larger plates/screws has been more
popular in the USA.
Status | Completed |
Enrollment | 126 |
Est. completion date | June 2009 |
Est. primary completion date | June 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 11 Years to 89 Years |
Eligibility |
Inclusion Criteria: - all patients with a fractured mandible - age 11 to 89 Exclusion Criteria: - Comminuted fractures |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | Grady Memorial Hospital | Atlanta | Georgia |
Lead Sponsor | Collaborator |
---|---|
Emory University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | fracture healing | 3 months | No | |
Secondary | malocclusion | 3 months | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT01834339 -
EVPOME Versus AlloDerm in Subjects Reconstructed With Large Defect Mandibular Resection
|
Phase 2 | |
Completed |
NCT03054012 -
Accuracy and Outcome of Computer-assisted Surgery for Bony Micro-vascular Reconstruction in the Head and Neck Region
|
||
Recruiting |
NCT03678467 -
Evaluation of EpiBone-CMF for Mandibular Ramus Reconstruction
|
Phase 1/Phase 2 |