Restorabite – Trismus

Intended Use
RestorabiteTM is intended to assist with jaw stretching and strengthening for treatment of trismus (restriction of jaw opening)`

Device Features:
Its’ unique multiple exercise level design allows for a varied force to be selected based on a patient’s specific needs, to ensure that:
*Adequate force and effort are beingused for maximal therapeutic gains.
*Excessive force is not applied to the teeth and jaw, to reduce or prevent therisk of complications and injuries relating to jaw stretching andstrengthening exercises.
*The force applied to the jaw can be modified by user needs.

Device Description
The Restorabite consists of:
Frame (Figures 1)
Insert (Figure 2)
Instruction For Use

The RestorabiteTM outer frame can house an insert at different locations providing varying resistance.

The RestorabiteTM is portable and handheld device. The outer wings of the frameare squeezed together by the user and placed between the upper and lower teeth or gums. The user then gradually releases the pressure applied by their fingers to allow the wings of the frame to deploy force to the jaw, stretching it open (passive range of motion exercise). The user can then bite down to activate the jaw muscles for astrengthening exercise (active range of motion exercise).

Indications:
The RestorabiteTM is indicated for use in individuals whose mouth opening is limited. Restricted mouth opening is known as ‘trismus’. Trismus can arise because of many medical conditions. Commencing rehabilitation for trismus should always be undertaken under the guidance of the user’s physician and experienced clinician.

The RestorabiteTM can be used for both rehabilitation and prevention of trismus. Rehabilitation exercises are undertaken when a user has trismus to improve their condition. Prevention or prophylactic use is for those who are at risk of developing trismus. The minimum mouth opening distance Restorabite is able to accommodate for is 8.0 mm.

Potential Benefits
The purpose of the Restorabite is to increase mouth opening. Reduced ability to open the mouth can lead to several health-related problems such
as pain, difficulty swallowing, speaking, conducting oral/dental care and accessing the airway. Addressing trismus using RestorabiteTM has led to improvements in mouth opening, speech and swallowing related quality of life and improved pain scores. The amount of improvement depends on the individual and their personal circumstances. The use of RestorabiteTM for trismus therapy provides a personalised exercise program for patients. Patients who used RestorabiteTM report increased adherence to exercise program and motivation for exercise program, improved quality of life, and a decreased pain (Charters et al 2022)

The report has shown the following benefits:
*Improved mouth opening
*Increased adherence to exercise program and motivation for exercise program
*Improved quality of life

Risks
Failure to follow the instructions for use may result in complications. Incorrect device handling (such as overstretching of the device), and devicecleaning (such as using the wrong cleaning agent) will increase the risks.
The RestorabiteTM should not be used without an individualised exercise program provided by your physician and/or trained clinician. Application of excessive force to the teeth or jaw can cause complications such as fractures. A patient’s physician can select the maximum force suitable for a patient based on their individual circumstances to mitigate this risk.

The following risks were associated with the
RestorabiteTM:
*Tension headache
*Neck pain
*Temporomandibular joint (TMJ) pain
*Tooth loss

If any of these complications occur, the user should contact their prescribing clinician.

CONTRAINDICATIONS
RestorabiteTM is not recommended for patients with any of the following conditions:
*Osteomyelitis or osteoradionecrosis of theirjaw (maxilla or mandible)
*Fracture of their jaw (maxilla or mandible)
*Unstable dentition
*Have active disease (e.g. untreated cancer ofthe jaw)
*The Restorabite has not been trialled inpatients under the age of 18 years.