Physical Exercises for Temporomandibular Disorders

NCT04819763 | Completed

• 1 other identifier: 0016032021
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Facial Pain; Temporomandibular Disorder; Temporomandibular Joint Disorders; Temporomandibular; Functional Disturbance

Keywords

physical therapy; stabilization appliance; clinical trial; dentistry

Outcome Measures

Primary Outcomes (1)

• change orofacial pain: numeric rating scale (NRS; 0-10)

  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

  2 months, 4 months, 6 months

Secondary Outcomes (3)

• Change in number of clicking noises

  2 months, 4 months, 6 months

• Change in interincisal distance during jaw opening

  2 months, 4 months, 6 months

• Change in force degrees for the lateral movement of the mandible (scale 0-5)

  2 months, 4 months, 6 months

Study Arms (2)

Physical training of the lateral pterygoid muscle

EXPERIMENTAL

Static stretching and isometric contraction exercises of the lateral pterygoid muscle are used to strengthen and restore a physiological lateral movement of the mandible.

Other: Physical therapy

Stabilization appliance therapy

ACTIVE COMPARATOR

Hard acrylic splint with anterior canine guidance for the lower jaw.

Other: Appliance therapy

Interventions

Physical therapy OTHER

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.)

Physical training of the lateral pterygoid muscle

Appliance therapy OTHER

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).

Stabilization appliance therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Drug abuse
• Depression
• Polyarthritis

Sponsors & Collaborators

• University Medicine Greifswald: lead

Study Sites (1)

Zahnarztpraxis Dr. Pfanne

Steina, 01920, Germany

Location

Related Publications (22)

• 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

  BACKGROUND

• 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.

  PMID: 12198864 BACKGROUND

• 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.

  PMID: 12725365 BACKGROUND

• 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

  BACKGROUND

• Janda V (2013) Muscle Function Testing. Butterworth-Heinemann

  BACKGROUND

• 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.

  PMID: 21528122 BACKGROUND

• 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.

  PMID: 21916356 BACKGROUND

• 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.

  PMID: 27472527 BACKGROUND

• 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.

  PMID: 31247061 BACKGROUND

• 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.

  PMID: 20438615 BACKGROUND

• 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.

  PMID: 16649894 BACKGROUND

• 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.

  PMID: 30563758 BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 3199322 BACKGROUND

• Okeson JP (2019) Management of Temporomandibular Disorders and Occlusion - E-Book. Elsevier Health Sciences

  BACKGROUND

• 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.

  PMID: 24482784 BACKGROUND

• 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.

  PMID: 31520538 BACKGROUND

• 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.

  PMID: 25121100 BACKGROUND

• 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.

  PMID: 16202045 BACKGROUND

• Wright EF, Klasser GD (2019) Manual of Temporomandibular Disorders. John Wiley & Sons

  BACKGROUND

• 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.

  PMID: 20140156 BACKGROUND

MeSH Terms

Conditions

Facial Pain; Temporomandibular Joint Disorders

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Olaf Bernhardt, Prof.

  University Medicine Greifswald

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Unblinded with respect to the examiner and to the patient, blinded to the statisticians in the evaluation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, randomized study with control group, stratified by gender.

Study Record Dates

• First Submitted: March 24, 2021
• First Posted: March 29, 2021
• Study Start: May 3, 2021
• Primary Completion: November 7, 2022
• Study Completion: April 30, 2023
• Last Updated: December 8, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)