Study Results
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Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2021-05-03
2023-04-30
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
Physical therapy
Coordination training for lateral movement of the mandible (spatula exercise):
1. A wooden spatula is loosely placed between the teeth of the upper and lower jaw; the head must be aligned with the body axis; the exercise should be performed in front of a mirror.
2. The lower jaw moves to the left and back to the center with little contact to the spatula
3. The lower jaw moves to the right and back to the center under contact with the spatula
Training of the left lateral pterygoid muscle:
1. The left palm is placed on the left temple region
2. Right hand forms a fist and is placed on the tip of the right chin
3. Both arms are aligned parallel to the surface of the floor
4. The lower jaw is moved to the right against a moderate resistance of the fist = concentric muscle work
5. With measured force of the fist, the lower jaw is brought back to the center = eccentric muscle work (Right lateral pterygoid muscle training with opposite hands.)
Stabilization appliance therapy
Hard acrylic splint with anterior canine guidance for the lower jaw.
Appliance therapy
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).
Interventions
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Physical therapy
Coordination training for lateral movement of the mandible (spatula exercise):
1. A wooden spatula is loosely placed between the teeth of the upper and lower jaw; the head must be aligned with the body axis; the exercise should be performed in front of a mirror.
2. The lower jaw moves to the left and back to the center with little contact to the spatula
3. The lower jaw moves to the right and back to the center under contact with the spatula
Training of the left lateral pterygoid muscle:
1. The left palm is placed on the left temple region
2. Right hand forms a fist and is placed on the tip of the right chin
3. Both arms are aligned parallel to the surface of the floor
4. The lower jaw is moved to the right against a moderate resistance of the fist = concentric muscle work
5. With measured force of the fist, the lower jaw is brought back to the center = eccentric muscle work (Right lateral pterygoid muscle training with opposite hands.)
Appliance therapy
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).
Eligibility Criteria
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Inclusion Criteria
* 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
* Depression
* Polyarthritis
18 Years
75 Years
ALL
No
Sponsors
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University Medicine Greifswald
OTHER
Responsible Party
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Principal Investigators
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Olaf Bernhardt, Prof.
Role: PRINCIPAL_INVESTIGATOR
University Medicine Greifswald
Locations
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Zahnarztpraxis Dr. Pfanne
Steina, , Germany
Countries
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References
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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
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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0016032021
Identifier Type: -
Identifier Source: org_study_id