- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04819763
Physical Exercises for Temporomandibular Disorders
Training of the Lateral Pterygoid Muscle in the Treatment of Anterior Temporomandibular Joint Disc Displacement With Reduction With Pain
Temporomandibular Disorders are a common clinical picture that appear in particular in people between the age of 20 and 40 years. About 33% of the total population shows symptoms and signs of TMD. Among the temporomandibular joint disorders anterior disc displacement appear to be the most common. In case of limitations of jaw movements and or pain conservative methods including combinations of behavior change, physiotherapy, stabilization appliance therapy and medication are most popular. The benefit of a self-treatment program to strengthen the lateral pterygoid muscle and to learn a properly executed lower jaw sideways movement to achieve pain reduction is up to now not well investigated. The aim of this study is to examine the effectiveness of muscle training for the treatment of patients with anterior disc displacement with reduction (DDWR). 60 patients with DDWR and pain (≥18 years) will be randomly allocated to two groups: 1. Physical exercises, 2. Stabilization appliance therapy. All patients receive a functional examination according to the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) at baseline.
The training in group 1 includes eccentric and concentric counter-movements of the lower jaw muscle to strengthen and restore a physiological lateral movement of the mandible. The muscle exercises should be performed once a day with 5-6 repetitions per side. The treatment with an equilibration appliance in the lower jaw serves as a comparison group. Patients are instructed to wear the appliance while sleeping. The wearing rhythm is described as intermittent. (three nights - wearing the appliance, one night - not wearing the appliance). The primary target variable is the occurrence of pain in the head and joint area before and during therapy. The variable is measured using a numeric rating scale (NRS; 0-10) during the baseline examination and control check-ups after 2, 4 and 6 months.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The literature describes the cause of a temporomandibular disorder (TMD) as a multifactorial event. It can be influenced by anatomical, neuromuscular, traumatic or psychosocial factors. Disturbances often occur in the condyle-disc complex of the temporomandibular joint. The relationship between the articular disc and the condyle head is pathologically altered. The Diagnostic Criteria for Temporomandibular disorders (DC / TMD) describe the displacement of the disc in 4 different forms: disc displacement with reduction; disc displacement with reduction and intermittent locking; disc displacement without reduction with limited opening and disc displacement without reduction without limited opening. TMDs are a common clinical picture that appears in particular in people between the age of 20 and 40 years. About 33% of the total population show signs and symptoms of TMD.
Studies prove that the displacement of the disc with reduction is the most common disorder among temporomandibular joint disorders. According to the DC / TMD, this clinical picture shows intracapsular and biomechanical alterations. If the mouth is closed, the articular disc is often located in front of the mandibular condyle; if the mouth is opened, the disc moves back to its original position on the condyle. Anterior disc displacement appears to be the most common, although a medial or lateral displacement is also possible. During the disc repositioning clicking, popping or snapping noises are usually recorded. Temporomandibular joint disorders such as disc displacement, can also cause pain. Overstretching of the posterior ligament and a compression of the bilaminar zone mandibular movements can be pain-related. Therefore, clicking, popping or snapping noises in the area of the temporomandibular joint (TMJ) correlate with pain in the surrounding tissue. Those complaints intensify when opening the mouth or chewing food.
The treatment of TMD should be oriented on evidence-based procedures that are easy to implement in practice and have a long-term positive effect on the patient's symptoms. Conservative methods including combinations of behavior change, physiotherapy, splint-therapy and medication are most popular. The physiotherapeutic treatment should pursue different strategies, including manual therapy methods (e.g. mobilization and stretching of the temporomandibular joint and / or the neck area) and the demonstration of exercises in everyday life (e.g. self-mobilization and stretching of the masticatory muscles and / or cervical spine) and in addition educating the patient (e.g. about the perception of parafunctions or relaxation techniques). Conservative attempts for patients with TMD should be the first choice. However, there is still no clear data situation and the data pool of randomized clinical studies on this topic needs to be improved. So far studies demonstrate a positive effect of the tested therapy forms. But the individual studies differ greatly in terms of the patient pool, diagnosis, treatment modalities and the result. Furthermore, a precisely described procedure is missing in some papers. Therefore, an exact reproducibility for practitioners is not executable. More research is needed into the benefits of various non-invasive treatments for TMD.
The primary goal of this study is to decrease the ambiguity in this scientific field. In the past various manual and physiotherapeutic exercise methods have already been tested.
This study is also intended to examine the effectiveness of muscle training for the treatment of patients with anterior disc displacement with reduction. The exercises are primarily supposed to train the lateral pterygoid muscle. The treatment with an equilibration appliance in the lower jaw serves as a comparison group.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Olaf Bernhardt, Prof.
- Phone Number: +49 3834 867325
- Email: obernhar@uni-greifswald.de
Study Contact Backup
- Name: Falk Pfanne, Dr.
- Phone Number: +49 35955 45577
- Email: falk.pfanne@zahnheilkunde-dr-pfanne.de
Study Locations
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Steina, Germany, 01920
- Zahnarztpraxis Dr. Pfanne
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Orofacial pain in the joint or muscles, degree NRS≥3
- Clicking phenomenon during TMJ opening or closing movement
- Deviation movement during opening of the lower jaw
- Legal competence and presence of the signed declaration of consent
Exclusion Criteria:
- Drug abuse
- Depression
- Polyarthritis
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Physical training of the lateral pterygoid muscle
Static stretching and isometric contraction exercises of the lateral pterygoid muscle are used to strengthen and restore a physiological lateral movement of the mandible.
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Coordination training for lateral movement of the mandible (spatula exercise):
Training of the left lateral pterygoid muscle:
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Active Comparator: Stabilization appliance therapy
Hard acrylic splint with anterior canine guidance for the lower jaw.
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Upper and lower jaw impressions are registered by using an intraoral scanner. The arbitrary hinge axis position is determined using a face bow. The stabilization appliance with anterior canine guidance is manufactured in the Lexmann laboratory in Dresden. The stabilization appliance is incorporated by the dentist and the static and dynamic occlusion is checked. A tension-free fit of the appliance on the lower jaw is necessary. Additionally, equal contacts in the side teeth area and incisors guidance in the case of mandibular protrusion are checked visually and by using occlusion foil. During mandibular lateral movement only the canine guidance takes place and is also registered optically and by using occlusion foil.Interference contacts should be adjusted. The patient is instructed to wear the stabilization appliance while sleeping. The wearing rhythm is described as intermittent. (three nights - wearing the appliance, one night - not wearing the appliance). |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change orofacial pain: numeric rating scale (NRS; 0-10)
Time Frame: 2 months, 4 months, 6 months
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The primary outcome variable is defined as the change of orofacial pain in the head and joint area after initiating the therapy measured by numeric rating scale (NRS; 0-10, 0: no pain, 10: worst imaginable pain) at the time of the follow-up appointments
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2 months, 4 months, 6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in number of clicking noises
Time Frame: 2 months, 4 months, 6 months
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Change in number of clicking noises in the TMJ during jaw opening or jaw closing movements established by palpation of the TMJs
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2 months, 4 months, 6 months
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Change in interincisal distance during jaw opening
Time Frame: 2 months, 4 months, 6 months
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Change in interincisal distance during maximum unassisted opening measured in mm between first upper and lower right incisor.
If one of the teeth is missing: first upper and lower left incisor
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2 months, 4 months, 6 months
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Change in force degrees for the lateral movement of the mandible (scale 0-5)
Time Frame: 2 months, 4 months, 6 months
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Evaluation of muscle forces during lateral jaw movements on a ordinal scale (0-5) according to Janda
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2 months, 4 months, 6 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Olaf Bernhardt, Prof., University Medicine Greifswald
Publications and helpful links
General Publications
- Schiffman E, Ohrbach R, Truelove E, Look J, Anderson G, Goulet JP, List T, Svensson P, Gonzalez Y, Lobbezoo F, Michelotti A, Brooks SL, Ceusters W, Drangsholt M, Ettlin D, Gaul C, Goldberg LJ, Haythornthwaite JA, Hollender L, Jensen R, John MT, De Laat A, de Leeuw R, Maixner W, van der Meulen M, Murray GM, Nixdorf DR, Palla S, Petersson A, Pionchon P, Smith B, Visscher CM, Zakrzewska J, Dworkin SF; International RDC/TMD Consortium Network, International association for Dental Research; Orofacial Pain Special Interest Group, International Association for the Study of Pain. Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) for Clinical and Research Applications: recommendations of the International RDC/TMD Consortium Network* and Orofacial Pain Special Interest Groupdagger. J Oral Facial Pain Headache. 2014 Winter;28(1):6-27. doi: 10.11607/jop.1151.
- Bumann, A., Groot Landeweer, G.: Manuelle Untersuchungstechniken zur Manuellen Untersuchungstechniken zur Differenzierung von Funktionsstörungen im Kausystem. In Hahn, W.: Funktionslehre: aktueller Stand und praxisgerechte Umsetzung. Hanser, München, 1993
- Eberhard D, Bantleon HP, Steger W. The efficacy of anterior repositioning splint therapy studied by magnetic resonance imaging. Eur J Orthod. 2002 Aug;24(4):343-52. doi: 10.1093/ejo/24.4.343.
- Egermark I, Magnusson T, Carlsson GE. A 20-year follow-up of signs and symptoms of temporomandibular disorders and malocclusions in subjects with and without orthodontic treatment in childhood. Angle Orthod. 2003 Apr;73(2):109-15. doi: 10.1043/0003-3219(2003)732.0.CO;2.
- El-Asfahani I, Kortam S (2020) Effect of CAD/CAM versus conventional anterior repositioning splints on the management of temporomandibular joint disc displacement with reduction: A randomized controlled clinical trial. Egyptian Dental Journal 66:571-585. doi: 10.21608/edj.2020.79131
- Janda V (2013) Muscle Function Testing. Butterworth-Heinemann
- Kalaykova SI, Lobbezoo F, Naeije M. Risk factors for anterior disc displacement with reduction and intermittent locking in adolescents. J Orofac Pain. 2011 Spring;25(2):153-60.
- Karacayli U, Mumcu G, Cimilli H, Sisman N, Sur H, Gunaydin Y. The effects of chronic pain on oral health related quality of life in patients with anterior disc displacement with reduction. Community Dent Health. 2011 Sep;28(3):211-5.
- Kumazaki Y, Kawakami S, Hirata A, Oki K, Minagi S. Ipsilateral Molar Clenching Induces Less Pain and Discomfort than Contralateral Molar Clenching in Patients with Unilateral Anterior Disc Displacement of the Temporomandibular Joint. J Oral Facial Pain Headache. 2016 Summer;30(3):241-8. doi: 10.11607/ofph.1405.
- Lindfors E, Arima T, Baad-Hansen L, Bakke M, De Laat A, Giannakopoulos NN, Glaros A, Guimaraes AS, Johansson A, Le Bell Y, Lobbezoo F, Michelotti A, Muller F, Ohrbach R, Wanman A, Magnusson T, Ernberg M. Jaw Exercises in the Treatment of Temporomandibular Disorders-An International Modified Delphi Study. J Oral Facial Pain Headache. 2019 Fall;33(4):389-398. doi: 10.11607/ofph.2359. Epub 2019 Jun 24.
- List T, Axelsson S. Management of TMD: evidence from systematic reviews and meta-analyses. J Oral Rehabil. 2010 May;37(6):430-51. doi: 10.1111/j.1365-2842.2010.02089.x. Epub 2010 Apr 20.
- McNeely ML, Armijo Olivo S, Magee DJ. A systematic review of the effectiveness of physical therapy interventions for temporomandibular disorders. Phys Ther. 2006 May;86(5):710-25.
- Nagata K, Hori S, Mizuhashi R, Yokoe T, Atsumi Y, Nagai W, Goto M. Efficacy of mandibular manipulation technique for temporomandibular disorders patients with mouth opening limitation: a randomized controlled trial for comparison with improved multimodal therapy. J Prosthodont Res. 2019 Apr;63(2):202-209. doi: 10.1016/j.jpor.2018.11.010. Epub 2018 Dec 15.
- Navi F, Kalantar Motamedi MH, Taheri Talesh K, Lasemi E, Nematollahi Z (2013) Diagnosis and Management of Temporomandibular Disorders. In: Kalantar Motamedi MH (ed) A Textbook of Advanced Oral and Maxillofacial Surgery. InTech
- Navi F, Motamedi MHK, TaheriTalesh K, Lasemi E, Nematollahi Z (2013) Diagnosis and Management of Temporomandibular Disorders. A Textbook of Advanced Oral and Maxillofacial Surgery. doi: 10.5772/55018
- Okeson JP. Long-term treatment of disk-interference disorders of the temporomandibular joint with anterior repositioning occlusal splints. J Prosthet Dent. 1988 Nov;60(5):611-6. doi: 10.1016/0022-3913(88)90224-7.
- Okeson JP (2019) Management of Temporomandibular Disorders and Occlusion - E-Book. Elsevier Health Sciences
- Wanman A, Marklund S. Treatment outcome of supervised exercise, home exercise and bite splint therapy, respectively, in patients with symptomatic disc displacement with reduction: A randomised clinical trial. J Oral Rehabil. 2020 Feb;47(2):143-149. doi: 10.1111/joor.12888. Epub 2019 Sep 30.
- Wieckiewicz M, Grychowska N, Wojciechowski K, Pelc A, Augustyniak M, Sleboda A, Zietek M. Prevalence and correlation between TMD based on RDC/TMD diagnoses, oral parafunctions and psychoemotional stress in Polish university students. Biomed Res Int. 2014;2014:472346. doi: 10.1155/2014/472346. Epub 2014 Jul 9.
- Wolfart S, Heydecke G, Luthardt RG, Marre B, Freesmeyer WB, Stark H, Wostmann B, Mundt T, Pospiech P, Jahn F, Gitt I, Schadler M, Aggstaller H, Talebpur F, Busche E, Bell M. Effects of prosthetic treatment for shortened dental arches on oral health-related quality of life, self-reports of pain and jaw disability: results from the pilot-phase of a randomized multicentre trial. J Oral Rehabil. 2005 Nov;32(11):815-22. doi: 10.1111/j.1365-2842.2005.01522.x.
- Wright EF, Klasser GD (2019) Manual of Temporomandibular Disorders. John Wiley & Sons
- Wright EF, North SL. Management and treatment of temporomandibular disorders: a clinical perspective. J Man Manip Ther. 2009;17(4):247-54. doi: 10.1179/106698109791352184.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0016032021
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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