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University of Maryland
Interim Report for Facial-Flex
® Corporation
By Edward G. Grace, D.D.S., M.A.
University of Maryland
February 11, 2001


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 1 minute at a time, a better schedule would be to use it 3 times a day for 1 minute at a time or twice a day for 2 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.

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