TheraBite Catalog 7827US_200511.indd - Stratmed.co.za

Contents3 Limited Jaw Mobility4-5 Life with Trismus6-7 The TheraBite ®Jaw MotionRehabilitation System8-9 Features10-11 The TheraBite ® systemconsists of…12 Treatment Program13 7-7-7 Protocol14 Testimonials15 Insurance andReimbursement16-17 Ordering Information18 Reference List20 User Manual andPrescriber Information2

Limited Jaw MobilityDifficulty or pain when opening the mouth maybe a sign of limited jaw mobility or trismus.Patients suffering from this condition can befound within many clinical disciplines, includingspeech & language pathology, radiation oncology,maxillofacial surgery and prosthodontics,otolaryngology, physical therapy, and dentalsurgery.Trismus is a serious yet frequently overlookedcondition. In many cases, it can not only causepain, but can also significantly impair importantday-to-day functions, such as chewing andswallowing, maintaining adequate oral hygiene,and communicating effectively with others.Who is affected?Trismus can affect people of all ages. Thecondition is attributed to muscle fibrosis; jointdamage and/or scarring, which in turn may becaused by the following:• Head and neck radiation therapy• Temperomandibular joint (TMJ) dysfunction• Surgery• Systemic diseases such as rheumatoid arthritisor scleroderma• Direct trauma• Indirect trauma such as whiplash• Clenching and grinding of the teeth• Stress-induced disorders• Burns• Stroke• Aging3

Life with TrismusWhat are the complications?Trismus can cause difficulty in:• Biting• Chewing• Swallowing• Speech• Maintaining oral hygiene• IntubationIn turn, these difficulties can result in costlymedical complications and can increasethe risk of:• Malnutrition• Inflammation and pain• Disuse atrophy• Changes in the joints• Poor wound healing• Inadequate oral assessment• Aspiration• Compromised airway• Osteoradionecrosis4

Quality of life!Trismus may not only affect an individual’sphysical health, but also his/her psychosocialwell-being:• Social interactions are often affected dueto reduced ability to communicate and toeat in public.• Exhaustion is common because more effortis required to execute simple tasks.• Appetite for life diminishes and can resultin social withdrawal, feelings ofhelplessness and resignation.• Depression can arise leading to decreasedability to cope with the condition.The vicious cycle of trismusPatients at risk of developing trismus should beevaluated and treated by a qualified clinician toprevent further restrictions to jaw opening orassociated chronic pain. The diagram below bestillustrates the vicious cycle of limited jaw mobility.Limited Jaw MobilityEarly detection and intervention can helppatients counter this debilitating conditionand prevent costly complications which maycompromise a patient’s quality of life and health.Inflammationand PainDisuse Atrophyand/or JointDegeneration5

The TheraBite ®Jaw Motion Rehabilitation SystemThe TheraBite ® Jaw Motion RehabilitationSystem is a portable system which utilizesrepetitive passive motion and stretchingto restore mobility and flexibility of the jawmusculature, associated joints and connectivetissues.The TheraBite Jaw Motion Rehabilitation Systemis available in an adult and a pediatric version.The pediatric version has smaller mouthpiecesthat are more suitable for patients with asmaller mouth.1. Increases Range of Motionof the Jaw:- STRETCHES connective tissueFibrous scar tissue causes tightening of muscleand joints and requires stretching to re-alignthe collagen fibers within. The Therabite systemprovides passive repetitive stretching to lengthenand reform these fibers and does so in ananatomically correct fashion.4.8 cm3.1 cmTreatment ObjectivesNumerous clinical studies have demonstratedthe efficacy of the TheraBite system ref: 1-5 . TheTheraBite system is designed to accomplish twotreatment objectives:6

- STRENGTHENS weakened musclesMuscles that have suffered from disuse atrophyrequire strengthening across the full range ofmotion.Using passive range of motion exercises, theTheraBite system helps to increase muscle massand endurance.- MOBILIZES jointsJoints that have been immobilized can undergodegenerative changes in a matter of days.The TheraBite system can safely mobilize thetemporomandibular joint across its full range ofmotion via passive motion.2. Pain Reduction- Reduces joint inflammationImmobilized joints lead to thickening of thesynovial fluid and thinning of cartilage. Thisstiffening of the joints ultimately leads toinflammation and pain.Exercising with the TheraBite system activatesanti-inflammatory agents that promote jointlubrication and reduce inflammation and pain.- Reduces muscle painMuscle pain (myofascial pain) is usually causedby inflammation which creates abnormalpressure on nerves, muscles, and bones. Thisinflammation process can be corrected throughpassive motion exercises.Rehabilation with the TheraBite system hasbeen proven to reduce joint and/or muscle painin as little as two weeks of therapy ref.4 .The TheraBite cycleThe diagram below illustrates how passivemovement and stretching with the TheraBitesystem can help to transform a vicious cycle intoa positive one.AntiInflammatoryactionPain reductionRange of Motion Exerciseswith the TheraBite SystemStretches connective tissuesStrengthens musclesMobilizes jointsIncrease inJaw Opening7

FeaturesAnatomically correctA unique feature of TheraBite system is itsability to follow natural curved motion of thejaw. The patented curved track of the TheraBiteJaw Mobilizer guides the mandible along ananatomically correct pathway.Patient controlledWhen using the TheraBite system, the patientis in control. Speed and opening range can beadjusted directly by the patient, using manualforce, or the Fine Adjustment Knob. This featurehelps to reduce anxiety levels and improvecompliance.The opening motion of the Jaw Mobilizer follows the naturalpathway of the mandible.The hand-operated Jaw Mobilizer is easy to use and gives thepatient control over the rehabilitation program.Lee Laino“One problem I faced after radiation for my base-of-tongue cancer was that I couldn’topen my mouth wide enough to chew properly. This also affected my speakingability and oral hygiene, which are essential in my business practice and for my overallquality of life. My speech-language therapist told me that I should try to improve myjaw mobility as quickly as possible when I finished my treatment. Initially, I pursued thetraditional manual exercises and stacking tongue depressors to force open the mouth.The results were disappointing.Then a progressive-thinking therapist recommended the TheraBite system, which I beganusing immediately. I am happy to say that within weeks my range of motion was restored topre-treatment levels and my oral health and lifestyle are uncompromised.”8

PortableThe TheraBite system is durable and lightweight.It can be conveniently stored in the CarryingBag provided for patients to continue theirrehabilitation program wherever they go.Load-bearing comfortThe mouthpieces are attached to theJaw Mobilizer and are designedin such a way that theload-bearing forcesof stretching spreadacross the teeth. This,together with theBite Pads, promotesa comfortable and evenstretch while protecting thepatient’s teeth.EffectivePassive motion and stretchingexercises with the TheraBite system are clinicallyproven to be an effective form of jaw therapy.It has been used with success by thousands ofpatients suffering from more than 30 differentconditions, ranging from post-radiation trismus toorofacial pain.9

The TheraBite systemconsists of…Range Setting ArmThe position of the Range Setting Arm can beadjusted between 25-45 mm and is used todetermine maximum opening appropriate toeach stage of rehabilitation.Bite PadsThe self-adhesiveBite Pads spreadthe force across theteeth and can be trimmedor stacked for customizedprotection. The Bite Pads come inadult, pediatric and edentulous versions.Range of Motion ScalesThe disposable Range of Motion Scalesallow the patient and his/her clinician tomake jaw opening measurements and tomonitor progress.10

Carrying BagThe durable nylon Carrying Bag keepsthe TheraBite system and accessoriestogether.Patient Progress LogThe daily and monthlyPatient ProgressLog enables the userand his/her treatingclinician to monitorprogress.Fine Adjustment KnobThe Fine Adjustment Knob can be usedto regulate opening speed and distanceif needed.Hand-AidThe Hand-Aid assiststhe patient in maintainingconstant opening duringstretching or strengtheningprograms.11

Treatment ProgramTreatmentPrior to using the Therabite system, eachpatient should consult his/her clinician, who willprescribe an individualized program of exercisetailored to the patient’s unique needs andabilities.A commonly used treatment program is 7-7-7:7 stretches performed 7 times per day, eachstretch held for 7 seconds. In total, this is aninvestment of less than ten minutes a day.Individuals who suffer from muscle and/or jointpain may benefit from longer stretch exercises.An example of a treatment program with longerstretches is 5-5-30: 5 stretches performed 5times per day or more, each stretch held for 30seconds.Regular monitoring, review, and evaluation bya properly trained clinician is essential for alltreatment programs. Depending on a patient’scondition and the judgment of his/her clinician,the type of program required may be modifiedover time.Expected Treatment outcomes:1 – 1.5 mm per weekA typical patient will gain from 1-4 mm of jawopening ability in the first session; however, thisgain is likely to be lost within the next few hours.Only by continuing to stretch and mobilize thejaw for several sessions per day can any lastingbenefit be achieved.Increased pain during the exercises should beavoided, as it can result in muscle guarding thatmay impair the effectiveness of the therapy andreduce compliance.The average sustainable gain is around1 – 1.5 mm per week. Thus, to achieve 10 mm ofsustainable gain, a patient may need to exercisefrom six to ten weeks.The number of daily exercise sessions with theTheraBite system typically decreases over time.Ultimately, many patients are usually able tomaintain the gain they have achieved by usingthe device just once or twice a day.12

7-7-7 Protocol1 2Peel off tape from Bite Pad to apply the BitePads to the mouthpieces.The longer the Bite Pads sit on themouthpieces, the stronger they adhere.3 4Place mouthpieces comfortably between teethSqueeze the Lever gently to the point of resistance.Hold for 7 seconds.5 6Slowly close the mouth andpause for 7 seconds.Squeeze the Lever again to the point of resistanceand hold for 7 seconds.7 seconds followed by a 7 second pause7 stretches7 times per day13

TestimonialsProf W. MendenhallProf. D. BuchbinderDivision of Maxillofacial Surgery, Department of Otolaryngology,Continuum Cancer Centers, New York, NY, USA“I have been prescribing the TheraBite system for more than ten years for my patientswho have limited range of motion of the jaw. Many of my patients have had surgery or radiationtreatment to the head and jaw area, and many of them have difficulty in opening their mouth.For many years, we used tongue depressors to help patients with limited range of motion of the jaw,but have determined that the TheraBite system provides a much better and faster result.”Department of Radiation Oncology, University of Florida Health Science Center, Gainesville, FL, USA“While treating patients with radiation for head and neck cancer, we have noted a meaningful numberof cases of trismus. We have tried many different approaches to the treatment of this condition, butare most impressed with the results of the TheraBite system. It is easy for patients to use, and offersconsistently positive results.”Lynn ActonMS, CCC/SLP, Speech Language Pathologist, New Haven, CT, USA“Head and neck cancer patients who undergo surgical resection, external beamradiation therapy or a combination of both treatments often suffer from trismus.Trismus effects ability to masticate, speech intelligibility and oral care. I have found the Therabite jawmotion system to be effective in the remediation of trismus in this population. The Therabite not onlystretches the muscles but passively moves the mandibular joint”.Prof R. ReichDepartment of Oral and Maxillofacial Surgery,University of Bonn, Germany“Over the past 13 years, I have used the TheraBitesystem in a wide variety of cases of limited jawfunction, including persons with trismus, personsrecovering from TMD surgery, and persons whohave experienced facial trauma.I have found the device to be welltoleratedby the patient, and have seen quiteconsistently good results across this widerange of etiologies. As with many therapeutictreatments, we see that early interventionprovides the best result for the patient.”Dr. B. StackDepartment of Otolaryngology, Head and Neck Surgery,University of Arkansas Center for Medical Sciences, LittleRock, AR, USA“I have used the TheraBite device in a variety ofpatients, including patients suffering from postsurgicaland post-radiation trismus, as well as onTMJ patients. The typical patient responds wellto the device, showing significant improvementin function. While rehabilitation does takesome time and effort, it is encouraging to manypatients, who find that they can resume eatingand speaking properly.”14

Insurance andReimbursement (USA only)Atos Medical Inc. handles all aspects of theinsurance process. We also accept assignmentsfor Medicare patients.The TheraBite system is eligible for Medicarereimbursement, however, reimbursementamounts may differ from state to state. Manyprivate insurance companies will also coverthe TheraBite system. Please note thateach insurance plan is individualized, andreimbursement may vary.How can I order?You can call, e-mail, or fax your order to:Atos Medical Inc.2202 N. Bartlett Avenue, Suite 100Milwaukee WI 53202Tel: 1 800 217 0025Fax: 1 414 227 9033E-mail: info.us@atosmedical.comwww.atosmedical.comIt is also possible to order the TheraBite systemfrom the Atos Medical Inc.webshop – www.atosdirect.comShould you require further information about theTheraBite system, please contact our customerservice representatives at the above-mentionedaddress.Patient information forms, prescription forms,and certificates of medical necessity can be sentto you upon request or you can download themfrom the www.atosmedical.com webpage.For Canadian insurance issues please contactAtos Medical Inc.15

Ordering InformationQuantity REFTheraBite ® Jaw Motion Rehabilitation System, Adult 1 pc TH001TheraBite ® Jaw Motion Rehabilitation System, Pediatric 1 pc TH002Set contents:• The Jaw Mobilizer• Bite Pad• Hand-Aid• Range of Motion Scale• Carrying Bag• Instructions for Use• Patient Progress Log1 pc4 pcs1 pc30 pcs1 pc1 pc1 pcTheraBite ® Range of Motion Scale150 pcs SC001TheraBite ® Bite Pad, Regular4 pcs PA001TheraBite ® Bite Pad, Edentulous4 pcs PA002TheraBite ® Bite Pad, Pediatric4 pcs PA00316

TheraBite Instructional DVDThis 14-minute film provides usefulinformation on trismus and demonstratesthe functions and benefits of the TheraBitesystem. This DVD is divided into severalchapters and features testimonials from aformer patient and two clinicians. Availablein English onlyTheraBite CD-ROM Clinician´s EditionThis educational tool is intended for theclinician. This CD-ROM contains clinicalpapers, articles, and presentation slides.All items are extractable and may be usedfor scientific presentations.Available in English only.TheraBite Picture CD-ROMThe Picture CD presents acomprehensive collection of digitalJPEG pictures and may be used forscientific presentations.Quantity REF1 pc1 pc 78471 pc 78467840 (PAL)7840-N (NTSC)TheraBite Display StandThis display stand is madeof frosted plexiglass forthe demonstration of theTheraBite system (adultversion only).It comes with an extra panelto display accessories.Note: No accessories comewith the display stand.1 pc 784517

1. Buchbinder D, Currivan RB, Kaplan AJ, Urken ML.Mobilization regimens for the prevention of jawhypomobility in the radiated patients. A comparison ofthree techniques. Journal ofOralmaxillofacial Surgery. 1993; 51:863-867.2. Cohen EG, Deschler DG, Walsh K, Hayden RE.Early use of a mechanical stretching device to improvemandibular mobility after composite resection:a pilot study. Arch Phys Med Rehabil.2005 Jul;86(7):1416-9.3. Dijkstra PU, Kalk WW, Roodenburg JL.Trismus in head and neck oncology: a systematicreview. Journal: Oral Oncol.2004 Oct; 40(9):879-89.4. Maloney GE, Mehta N, Forgione AG, Zazawi KH,Al-Badawi EA, Driscoll SE. Effects of a passive jawmotion device on pain and range of motion in TMDpatients not responding to flat plane intraoralappliances. The Journal of CranioMandibularPractice, 2002; 20:55-66.5. Messing BP, Saunders JR, Dietrich-Burns K, Farrell SS,Pyrke-Fairchild J, Melick CF. Trismus management inthe head and neck cancer patient undergoing organpreservation treatment. 6th International Conferenceon Head and Neck Cancer, Washington DC, USAAugust 07-11, 2004. Scientific Poster 01-97.6. Bandy WD, Irion JM, Briggler M. The effect of staticstretch on the flexibility of the hamstring muscles.Physical Therapy 1997; 77: 1090-1096.7. Cohen GS, Fletcher M. Comparison of Jaw MobilizationRegimens. Journal of Dental Research, 1991; 70:329.8. Clark HM. Neuromuscular Treatments for Speech andSwallowing: A Tutorial. American Journal of Speech-Language Pathology. 2003; 12:400-415.9. De Deyne PG. Application of passive stretch and itsimplications for muscle fibers. Physical Therapy.2001; 81:821-822.and Related Research 1984; 185:113-120.11. Gassner R, Buckley M, Studer RK, Evans CH, Agarwal S.Interaction of strain and interleukin-1 in articularcartilage: effects on proteoglycan synthesis inchondrocytes; International Journal of Oral andMaxillofacial Surgery 2000; 29:389-394.12. Gaziano JE. Evaluation and management oforopharyngeal dysphagia in head and neck cancer.Cancer Control. 2002; 9: 400-408.13. Milam S, Zardeneta G. Oxidative stress anddegenerative temporomandibular joint disease -A proposed hypothesis. Journal of Oral andMaxillofacial Surgery 1998; 56:214-223.14. Nicolakis P, Burak E, Kopf A, Djaber-Ansari A,Piehslinger E, Fialka-Moser V, Exercise therapy forcraniomandibular disorders: Archives of PhysicalMedical Rehabilitation, 2001; 81:1137-1141.15. Nicolakis P, Burak EC, Kollmitzer J, Kopf A, Piehslinger E,Wiesinger GF, Fialka-Moser V. An investigation of theeffectiveness of exercise and manual therapy intreating symptoms of TMJ osteoarthritis.Cranio: The Journal of Crianiomandibular Practice.2001; 19(1):26-3216. Nicolakis P; Erdogmus B; Kopf A; Nicolakis M;Piehslinger E; Fialka-Moser V. Effectiveness of exercisetherapy in patients with myofascial pain dysfunctionsyndrome. Journal of Oral Rehabilitation.2002; 29(4):362-368.17. Salter RB The biological concept of continuous passivemotion of synovial joints; the first 18 years of basicresearch and its clinical application.Clinical Orthopaedics and Related Research:1989: 242:12-26.18. Sapega AA, Quedenfeld TC, Moyer RA, Butler RA.Biophysical factors in range-of-motion exercise.Physical Sports Medicine. 1981; 9(12):57-61.10. Frank C, Akeson WH, Woo SL-Y, Amiel D, Ing D,Coutts RD. Physiology and therapeutic value ofpassive joint motion. Clinical Orthopaedics18

About Atos MedicalAtos Medical was founded in 1986 with a visionto improve the lives of people suffering fromear, nose, and throat (ENT) problems. Today,we develop and manufacture a wide range ofreliable, safe and cost-effective ENT products.We are a global leader in voice and pulmonaryrehabilitation products and are expandingsteadily in the areas of dysphagia, orofacial,otology and rhinology.Atos Medical acts and excels in every step ofthe product cycle - development, quality control,production, marketing, and sales to ensurethat we are at the pinnacle of innovation andquality. We believe in building a close workingrelationship with clinicians and patients. Someof our most innovative products have beendeveloped in close collaboration with ourcustomers.Atos Medical is an expansive and dynamicworldwide corporation based in the renownedÖresund cluster for medical device andpharmaceutical companies in the south ofSweden. Our headquarter houses state-of-theartproduction and R & D facilities which meetthe rigorous requirements for manufacturingmedical devices. We have subsidiaries in theUS, UK, Germany, the Netherlands, Spain,Belgium and Switzerland as well as exclusivedistributors in over 50 countries.Through an intimate and extensive network ofinterconnected companies, scientists, cliniciansand patients, we are able to integrate thebenefits of research and development as well asfoster continual innovation. Our success is alsoreflected by our net turnover which has risen byan average of 20% to 40% annually for the past10 years.U.K. Sales office:Platon Medical LtdP O Box 2568, Eastbourne,East Sussex BN21 3HZ,United KingdomTel: 01323 431 930 • Fax: 01323 732 606platon@mistral.co.uk • www.atosmedical.comNiederlassung:Atos Medical GmbHCarl Schuricht Strasse 3,DE-65187, Wiesbaden,GermanyTel: 0611 445 70-0 • Fax: 0611 445 7023info.de@atosmedical.com • www.atosmedical.comVerkoopadres in NederlandAtos Medical BVBlauw-roodlaan 286Postbus 574, 2700 AN ZoetermeerThe NetherlandsTel: 079 593 5000 • Fax: 079 593 5009Info.nl@atosmedical.com • www.atosmedical.comOficina de ventas de España:Atos Medical Spain S.L.C/Aragon 208-210 3 o 3 a ,ES-08011, Barcelona,SpainTel: 93 323 9195 • Fax: 93 451 3695info.es@atosmedical.com • www.atosmedical.comBureau de vente en BelgiqueVerkoopskantoor in BelgiëAtos Medical BVBA / SPRLKoningsstraat 266 Rue RoyaleBE - 1210 Brussel / BruxellesTel 02 / 218 55 50 • Fax 02 / 218 55 51info.be@atosmedical.com • www.atosmedical.comAtos Medical branch office in SwitzerlandMainaustrasse 15,Postfach 8034ZürichTel: 0840 480 490 • Fax: 0840 480 400info.ch@atosmedical.com19

User manual and prescriber informationThis catalog does not replace nor does it set forth the complete contents of theUser Manual for the TheraBite ® Jaw Motion Rehabilitation System, and is nota substitute for reviewing and understanding that important information. Therefore,before using the TheraBite ® Jaw Motion Rehabilitation System, pleasereview the entire contents of the User Manual.The User Manual and Prescriber Information for the TheraBite ® Jaw MotionRehabilitation System are available online at www.atosmedical.com. You mayobtain a copy of the User Manual by calling 1-800-217-0025 (in the USA), sendingan e-mail to info@atosmedical.com, or writing to Atos Medical AB (PO Box183, SE 242 22, Hörby, Sweden). In addition, copies of the User Manual can beobtained from your TheraBite ® Jaw Motion Rehabilitation System supplier.Intended use / IndicationsThe TheraBite ® system is intended for use in individuals who are restricted intheir ability to open their jaws (trismus or jaw hypomobility).The TheraBite ® system is intended for use in individuals who experience pain inthe joints and/or muscles of the jaw.The TheraBite ® system may also be used as a rehabilitation tool for postoperativephysical therapy of the jaw.Patients at risk of developing limited jaw motion may consider the TheraBite ®system for prophylactic use on the advice and under the supervision of a trainedclinician.Prospective users should consult their clinician to determine whether the Thera-Bite ® system is appropriate for their individual conditions.ContraindicationsThe TheraBite ® system should not be used by individuals who have or may havea fracture in the maxilla or mandible (upper or lower jaw) or other weaknessesof the bones of the jaw.Patients with infections of the jaw, osteomyelitis, or osteoradionecrosis of thejaw should not use the TheraBite ® system.WarningsIf the user feels unexpected pain at any time while using the TheraBite ® system,the user should immediately stop using the product and should immediatelycontact his or her clinician.Injury may occur if excessive force is applied while using the TheraBite ® system,especially in users with weakened dentition, periodontal disease, weakenedbones or joints, or gap-bridging plates. Users should disclose any such conditionto their clinician before using the TheraBite ® system and should exerciseextreme caution while using the product.Before commencing any rehabilitation regimen involving the TheraBite ® system,all users should receive a thorough, professional evaluation by a clinician whois properly trained in the diagnosis of mandibular dysfunction. All therapeuticprograms and rehabilitation regimens involving the TheraBite ® system shouldinclude regular monitoring, review, and evaluation by a clinician.CautionsThe TheraBite ® system is intended for single-patient use only.Do not expose the TheraBite ® system to direct sunlight and excessive moisture.Do not expose the TheraBite ® system to extreme temperatures.Do not sterilize the TheraBite ® system. Sterilization processes may weaken thematerials out of which the device is manufactured, as well as the bonding of themouthpieces, and cause failure under load.Always handle the TheraBite ® system with care.Limited WarrantyAtos Medical makes no warranty, either expressed or implied, as to the lifetimeof the product delivered to the purchaser hereunder, which may vary with individualuse and biological conditions. Further, Atos Medical makes no warrantyof merchantability or fitness of the product for any particular purpose.Please note:Information in French is available online at www.atosmedical.com.Patents and TrademarksThe TheraBite ® Jaw Motion Rehabilitation System is protected by UnitedStates patent (4.909.502 and 5.035.420), as well as by other patents andpatents pending worldwide.TheraBite ® is a registered trademark owned by Atos Medical AB, Sweden.©Atos Medical AB, 200511, REF 7827USHead office:Atos Medical ABP.O. Box 183, SE-242 22 Hörby, SwedenTel: Int +46 (0)415 198 00 • Fax: Int +46 (0)415 198 98info@atosmedical.com • www.atosmedical.comU.S. Sales Office:Atos Medical Inc.2202 N Bartlett Avenue, Suite 100, Milwaukee, WI 53202, U.S.A.Tolfree:1 800 217 0025 • Fax: 1 414 227 9033info.us@atosmedical.com • www.atosdirect.com