Facial PainNCT04819763
Physical Exercises for Temporomandibular Disorders
A study testing Physical therapy and Appliance therapy in people with Facial Pain and Temporomandibular Disorder, run by University Medicine Greifswald at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Facial Pain, Temporomandibular Disorder, Temporomandibular Joint Disorders
- What is being tested?
- Physical therapy and Appliance therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- 3 May 2021to 30 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Drug abuse
- Depression
- Polyarthritis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Facial Pain, Temporomandibular Disorder, Temporomandibular Joint Disorders, Temporomandibular; Functional Disturbance
- Being tested
- Physical therapy, Appliance therapy
- Keywords
- physical therapy, stabilization appliance, clinical trial, dentistry
- Medical subject headings
- Facial Pain, Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical therapyOther
Coordination training for lateral movement of the mandible (spatula exercise):
- 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.
- The lower jaw moves to the left and back to the center with little contact to the spatula
- The lower jaw moves to the right and back to the center under contact with the spatula
Training of the left lateral pterygoid muscle:
- The left palm is placed on the left temple region
- Right hand forms a fist and is placed on the tip of the right chin
- Both arms are aligned parallel to the surface of the floor
- The lower jaw is moved to the right against a moderate resistance of the fist = concentric muscle work
- 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 therapyOther
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Physical therapy |
| Stabilization appliance therapy | Active comparator | Hard acrylic splint with anterior canine guidance for the lower jaw. Receives: Other: Appliance therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 months, 4 months, 6 months
Secondary outcomes (3)
Change in number of clicking noises
Change in number of clicking noises in the TMJ during jaw opening or jaw closing movements established by palpation of the TMJs
Measured: 2 months, 4 months, 6 months
Change in interincisal distance during jaw opening
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
Measured: 2 months, 4 months, 6 months
Change in force degrees for the lateral movement of the mandible (scale 0-5)
Evaluation of muscle forces during lateral jaw movements on a ordinal scale (0-5) according to Janda
Measured: 2 months, 4 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2021
- Study start3 May 2021
- Primary completion7 Nov 2022
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Facial PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomized study with control group, stratified by gender.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medicine Greifswald
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olaf Bernhardt, Prof., Principal investigator, University Medicine Greifswald
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04819763
- Sponsor's protocol ID
- 0016032021
- Status last verified
- Dec 2023
- First submitted
- 24 Mar 2021
- Last updated
- 8 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 12198864Egermark 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.
PubMed 12725365El-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.
PubMed 21528122Karacayli 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.
PubMed 21916356Kumazaki 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.
PubMed 27472527Lindfors 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.
PubMed 31247061List 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.
PubMed 20438615McNeely 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.
PubMed 16649894Nagata 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.
PubMed 30563758Navi 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.
PubMed 3199322
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Training of the Lateral Pterygoid Muscle in the Treatment of Anterior Temporomandibular Joint Disc Displacement With Reduction With Pain
- ClinicalTrials.gov ID
- NCT04819763
- Acronym / sponsor ID
- 0016032021
- Conditions
- Facial Pain, Temporomandibular Disorder, Temporomandibular Joint Disorders, Temporomandibular; Functional Disturbance
- Keywords
- physical therapy, stabilization appliance, clinical trial, dentistry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Medicine GreifswaldUniversity, hospital or other
- Study start
- 3 May 2021 (actual)
- Primary completion
- 7 Nov 2022 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 29 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, randomized study with control group, stratified by gender.
| Arm | Type | Receives |
|---|---|---|
| Physical training of the lateral pterygoid muscle | Experimental | Other: Physical therapyStatic stretching and isometric contraction exercises of the lateral pterygoid muscle are used to strengthen and restore a physiological lateral movement of the mandible. |
| Stabilization appliance therapy | Active comparator | Other: Appliance therapyHard acrylic splint with anterior canine guidance for the lower jaw. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Drug abuse
- Depression
- Polyarthritis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical therapyCoordination 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.) | Other | Physical training of the lateral pterygoid muscle |
| Appliance therapyUpper 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). | Other | Stabilization appliance therapy |
Primary outcome
change orofacial pain: numeric rating scale (NRS; 0-10)
Time frame: 2 months, 4 months, 6 months
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
3 secondary outcomes
Change in number of clicking noises
Time frame: 2 months, 4 months, 6 months
Change in interincisal distance during jaw opening
Time frame: 2 months, 4 months, 6 months
Change in force degrees for the lateral movement of the mandible (scale 0-5)
Time frame: 2 months, 4 months, 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2023.
- BackgroundBumann, 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: PubMed 12198864Eberhard 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.
- Background: PubMed 12725365Egermark 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.
- BackgroundEl-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
- BackgroundJanda V (2013) Muscle Function Testing. Butterworth-Heinemann
- Background: PubMed 21528122Kalaykova 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.
- Background: PubMed 21916356Karacayli 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.
- Background: PubMed 27472527Kumazaki 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.
- Background: PubMed 31247061Lindfors 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.
- Background: PubMed 20438615List 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.
- Background: PubMed 16649894McNeely 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.
- Background: PubMed 30563758Nagata 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olaf Bernhardt, Prof. principal investigator
University Medicine Greifswald
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical therapy and Appliance therapy in people with Facial Pain and Temporomandibular Disorder, run by University Medicine Greifswald at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change orofacial pain: numeric rating scale (NRS; 0-10) (time frame: 2 months, 4 months, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04819763, which also lists 22 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2023.