Introduction
A study of the Facial Flex
device called the Bite Assist Exerciser or BAE was
begun in late June, 2000 and the last data collection
was performed in January of 2001. The purpose of
the study was to evaluate the clinical performance
of the BAE and validate that it performs as intended,
which is to reduce muscle tension and increase muscle
strength and muscle tone in patients with muscle
dysfunction and or muscle pain, associated with
specific Temporomandibular Joint Disorders (TMD).
The muscles usually affected adversely in most TMD
patients are the muscles of mastication, which include
the ptyergoids, masseters, and temporalis muscles.
These are the same muscles that have been shown
in earlier studies to be positively affected by
the use of the BAE exercise device.
Conclusions
The BAE was shown to be a safe,
simple, and efficient method of muscular exercise
for TMD patients with a variety of diagnoses which
included some form of muscular dysfunction.
Discussion
The BAE was found to be a clinically
useful device by both patients and dentists. Statistically
no difference could be found between the groups,
but trends toward efficacy of the BAE were detected.
It may be useful in future studies to use a larger
number of patients in order to be able to detect
statistical significance. The clinical staff also
felt that although it was recommended to use the
appliance twice a day for one minute at a time,
a better schedule would be to use it three times
a day for one minute at a time or twice a day for
two minutes at a time, depending on patient needs.
The utilization of the combination of the BAE device
with the original Facial Flex device may also help
in the alleviation of muscular problems. The combination
of horizontal and vertical programmed exercise with
a measured amount of resistance could prove to be
more helpful than the BAE alone.
Comments
from Patients and Investigators
No patients had any adverse
comments about the BAE. The original green exerciser
was too “strong” for most patients but
the newly designed one is very complimentary to
the blue and yellow. There were no adverse outcomes
from use of the BAE and no patients became worse
with the use of the BAE. No patient was unable to
understand the instructions for use and all were
able to use the BAE properly.
The principal investigator
likes the BAE as part of a good physical therapy
home exercise and thermomodality regimen. Other
dentists who have seen the BAE in use also plan
to use it as a part of routine muscular TMD therapy.
Further data analysis is being performed and follow-up
of patients who have not responded is continuing.
