TMJ DisorderNCT07350239
Clinical, Microbial and Tissue-based Characterization of Patients Treated for Severe Temporomandibular Joint Pathology
An observational study of TMJ Disorder and Ankylosis, run by Örebro University, Sweden.
Trial summary
The general objective of this observational study is to clarify the clinical, microbial, and tissue characteristics, aetiology, and risk factors behind severe TMJ pathology. The main questions it aims to answer are: What are the clinical and histologic characteristics of patients with severe pathology of the TMJ? Can… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- TMJ Disorder, Ankylosis, Osteoarthritis
- What is being tested?
- open TMJ surgery such as arthroplasty surgery with or without autogen or allogen reconstruction
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2026to 1 Feb 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients (n=20) offered open TMJ surgery such as arthroplasty surgery with or without autogen or allogen reconstruction due to TMJ ankyloses or severe osteoarthritis. Patients treated at Karolinska University Hospital, Örebro University Hospital or Lund University Hospital. Exclusion criteria: suspicion of malignancy, inability to give consent.
Who may be able to join
- Patients subjected to open TMJ surgery such as arthroplastic surgery with or without autogen or allogen reconstruction
- Preserved biobank material (resected bone and soft tissue).
Who cannot join
- Absence of biobank material.
- Inability to give informed consent.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Prospective Clinical, Microbial and Tissue-based Characterization Analyses of Severe Temporomandibular Joint Pathology
The general objective of this observational study is to clarify the clinical, microbial, and tissue characteristics, aetiology, and risk factors behind severe TMJ pathology. The main questions it aims to answer are:
- What are the clinical and histologic characteristics of patients with severe pathology of the TMJ?
- Can microbial DNA be found in TMJ tissue from patients with severe pathology of the TMJ, and if so, does this correlate to the outcome of the surgery?
Read the detailed description
The temporomandibular joint (TMJ) is a synovial joint characterized by a combination of rotation and translation during mouth opening. Unlike other joints in the body, the joint cartilage is fibrous and innervated by cranial nerves. Normal TMJ function is essential for vital functions such as eating, including proper mouth opening capacity, as well as for social activities such as talking, laughing, singing, and kissing. Several studies have reported a severe impact on the quality of life for patients with impaired and painful TMJ function.
Temporomandibular joint disorders (TMD) are common, affecting approximately 20% of the population with a strong, as yet unexplained, female predominance. The aetiology of internal derangement of the TMJ is unknown, but trauma and local or general joint hypermobility have been discussed as possible predisposing factors.
In a small proportion of patients, severe TMJ pathology, including ankylosis, develops. If ankylosis occurs, the condylar process of the mandible becomes fused to the fossa by fibrotic or bony tissue, resulting in severely restricted mouth opening ability. This can lead to a total inability to move the jaw, which can, in turn, be potentially life-threatening due to compromised airways in case of nausea.
In developing countries, TMJ ankylosis usually develops during early childhood as a complication of otitis media (inflammation of the middle ear). In the industrialized world, the condition is more frequent in adults. Factors suggested to cause severe TMJ disease, including ankylosis, are local or systemic infections or rheumatic diseases. According to some studies, a common etiological factor is trauma through intra-articular hematoma, tissue scarring, and excessive bone formation. Since most TMJ trauma resolves uneventfully, this does not explain the individual susceptibility to developing severe TMJ pathology. Thus, the aetiology and epidemiology of these conditions remain unknown.
Previous data point in different directions regarding the role of bacteria in TMJ pathology. However, knowledge regarding the role of chronic, low-virulent microbial challenges in post-surgically deteriorating cases with severe arthritis or ankylosis is lacking. Furthermore, the histopathologic presentation of these conditions is largely unknown, and systematic approaches for tissue categorization and diagnostics are lacking.
There are different surgical procedures available for these severe TMJ conditions, including osteoarthrectomy (removal of the joint bone), interpositional osteoarthrectomy using the temporalis muscle, and/or joint reconstruction using alloplastic materials or autogenous grafts. The choice of surgical technique is debated, and supporting long-term follow-up studies are lacking.
Previous studies have mainly focused on surgical interventions in a series of patients with TMJ disease without accounting for diagnosis or clinical presentation, leading to uncertainties regarding treatment decisions and efficacy. Knowledge of the mechanisms behind severe TMJ disease will improve the understanding, prediction, management, and prognosis of these conditions.
- Conditions
- TMJ Disorder, Ankylosis, Osteoarthritis
- Being tested
- open TMJ surgery such as arthroplasty surgery with or without autogen or allogen reconstruction
- Keywords
- TMJ, Temporomandibular joint, TMJ disorder, oral and maxillafacial surgery, TMJ pain, TMJ ankylosis, Severe osteoarthritis
- Medical subject headings
- Temporomandibular Joint Disorders, Ankylosis, Osteoarthritis, Temporomandibular ankylosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
open TMJ surgery such as arthroplasty surgery with or without autogen or allogen reconstructionProcedure or surgery
Consecutive patients (n=20) were offered open TMJ surgery, such as arthroplasty surgery with or without autogenous or allogenic reconstruction, due to TMJ ankylosis or severe osteoarthritis. The patients were treated at Karolinska University Hospital, Örebro University Hospital, or Lund University Hospital.
| Study group | Role | What they receive |
|---|---|---|
| Patients with TMJ ankylosis or severe osteoarthritis of TMJ. | Not described Receives: Procedure: open TMJ surgery such as arthroplasty surgery with or without autogen or allogen reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical investigation (patients):
Preoperatively, 1 week postoperatively, and at 1, 3, 6, and 12 months, or at the last visit after surgery, objective measures according to clinical routines for TMJ internal derangement patients will be collected. MRI and/or CBCT/CT will be performed preoperatively. Subjective measures include scoring functional severity and grading symptoms according to a 10-point visual analogue scale (VAS) in terms of pain intensity, functional disability, and psychosocial impact.
Measured: Inclusion will take at least 3 years, followed by one year of follow-up
Questionnaires:
Three questionnaires: Oral Health Impact Profile-14 (OHIP-14), Jaw Function Limitation Scale-8 (JFLS-8), and EuroQol-5D-5L will be distributed to the patients. The patients will complete the questionnaires at the first visit and at the one-year follow-up after surgery. All three questionnaires are validated and available in Swedish.
OHIP-14: 14 questions answered on the scale:
- Does not apply to me, Very often, Quite often, Sometimes, Rarely, Never.
JFLS-8: 8 questions answered on the scale:
- 0 (no limitation) up to 10 (major limitation).
EuroQol-5D-5L: 5 questions, each with 5 options, that can be answered with:
- Yes or No."
Measured: Inclusion will take at least 3 years, followed by one year of follow-up.
Histopathologic analyses:
Fresh specimens from resected TMJ tissue will be processed with formalin fixation (4%) for a minimum of 48 hours and sent to the Pathology department. The tissue will be decalcified with 7% formic acid for 2-4 weeks. The decision to arrest the decalcification process will depend on the softness of the tissue, which will be assessed by using the ability of a needle to transpierce the sample. Thereafter, the specimens will be dehydrated and paraffin-embedded according to routine procedures. For routine histological diagnoses, 3 μm thick sections will be stained with hematoxylin and eosin. Immunohistochemistry staining, as well as other complementary staining methods, will be performed using antibodies based on the results of the retrospective analyses. Part of the specimens will be fresh frozen.
A specialist in pathology will review all the samples, categorize them, and assess them to identify any common denominators between the samples.
Measured: 3 years
Analysis of microbial DNA in the Biobank material using 16S metagenomic sequencing
Microbial DNA analyses will be performed on formalin-fixed paraffin-embedded (FFPE) soft tissue specimens from the biobank. DNA will be purified using the QIAamp DNA FFPE Advanced UNG Kit (Qiagen) with an additional bead-beating step. The full-length 16S rRNA gene (variable V1-V9 regions) will be sequenced to identify the bacterial organisms at the species level. Amplification of the 16S rRNA gene (~1500bp) and library preparation will be performed using the 16S Barcoding Kit (Oxford Nanopore Technology, ONT), allowing multiplexing of samples and thereby reducing costs.
Specialists in molecular biology and bioinformaticians will handle the results. Everything, from whether bacterial DNA is found to which different bacteria are present in what quantities, will be noted.
Measured: 3 years
Objective & Subjective measurements
Registration:
(Specify in writing)
- Past and current diseases
- Medication
- Medicational allergy
Preoperative information registered at the initial visit:
- TMJ trauma (yes/no)
- TMJ dislocation (yes/no)
- Parafunction (None/ Grinding/ Clenching)
Preoperative Symptoms (Initial Visit, Subjective)
- Crepitation: (Right/Left)
- Clicking/Locking: (Right/Left)
- Locking: (Right/Left)
- Movement Pain: (Right/Left)
- Restricted Mouth Opening: (Right/Left)
- Difficulty Eating: (yes/no)
- Difficulty Speaking: (yes/no)
- Other: (write in text)
Preoperative TMJ-Related Treatment
- None
- Conservative treatment: Bite splint, movement training, NSAIDs, bite correction, occlusal therapy
- Corticosteroid injection
- Arthrocentesis
- Arthroscopy: Date (year \& which joint):
- Open joint surgery: (If previous surgery, specify which and year)
- Other treatments
Surgery:
- Surgical date
- Age at surgery
- Type of surgery
- Surgical side (Right/left/bilateral)
Measured: Inclusion will take at least 3 years. Then one year follow up
Objective and subjective measurments
The following measures will be recorded using the Visual Analog Scale (VAS) of 0-10:
TMJ Pain During Function:
- Measured on a scale from 0 to 10 for pain intensity.
- Right/left TMJ will be assessed separately.
- Time points: Preoperative, 1 month postoperative, 3 months postoperative, 6 months postoperative, 1 year postoperative, 2 years postoperative.
Measured: Inclusion will take at least 3 years. Then one year follow up
Objective and subjective measurments
Palpation Tenderness Over the Temporomandibular Joints Laterally:
- Scale: Yes/No for tenderness.
- Right/Left TMJ.
- Time points: Preoperative, 1 month postoperative, 3 months postoperative, 6 months postoperative, 1 year postoperative, 2 years postoperative.
Palpation Tenderness Over the Masticatory Muscles (Pain Rating >2 on the Same Side):
- Scale: Yes/No for tenderness.
- Right/Left TMJ.
- Time points: Preoperative, 1 month postoperative, 3 months postoperative, 6 months postoperative, 1 year postoperative, 2 years postoperative.
Measured: Inclusion will take at least 3 years. Then one year follow up
Objective and subjective measurments
The following measures will be recorded using the Visual Analog Scale (VAS) of 0-10:
Functional Impairment (Eating, Chewing, Biting)
- Measured on a scale from 0 to 10 for difficulty in performing these functions.
- Right/left TMJ will be assessed separately.
- Time points: Preoperative, 1 month postoperative, 3 months postoperative, 6 months postoperative, 1 year postoperative, 2 years postoperative.
Measured: Inclusion will take at least 3 years. Then one year follow up
Objective and subjective measurments
The following measures will be recorded using the Visual Analog Scale (VAS) of 0-10:
Global Pain:
- Measured on a scale from 0 to 10 for overall pain experience.
- Time points: Preoperative, 1 month postoperative, 3 months postoperative, 6 months postoperative, 1 year postoperative, 2 years postoperative.
Measured: Inclusion will take at least 3 years. Then one year follow up
Objective and subjective measurments
The following measures will be recorded using the Visual Analog Scale (VAS) of 0-10:
Psycho-social Influence:
- Measured on a scale from 0 to 10 for the psychological or social impact of pain and dysfunction.
- Time points: Preoperative, 1 month postoperative, 3 months postoperative, 6 months postoperative, 1 year postoperative, 2 years postoperative.
Measured: Inclusion will take at least 3 years. Then one year follow up
Objective and subjective measurments
Maximal Interincisal Opening:
- Scale: Measured in millimeters.
- Time points: Preoperative, 1 month postoperative, 3 months postoperative, 6 months postoperative, 1 year postoperative, 2 years postoperative.
Maximal Lateral Movement (TMJ):
- Measured in millimeters.
- Right/Left TMJ.
- Time points: Preoperative, 1 month postoperative, 3 months postoperative, 6 months postoperative, 1 year postoperative, 2 years postoperative.
Measured: Inclusion will take at least 3 years. Then one year follow up
Secondary outcomes (2)
Objective and subjective measurments
Occlusal Relationships:
- Written description of the occlusal relationship.
- Time points: Preoperative and 1 year postoperative
Measured: Inclusion will take at least 3 years. Then one year follow up
Objective and subjective measurments
Postoperative Complications
- Written description of complications:
- Nerve Damage: Yes/No, and specify if transient (with duration) or permanent.
- Infection: Yes/No, and specify treatment (if any).
Measured: Inclusion will take at least 3 years. Then one year follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start1 Mar 2026 (estimated)
- Primary completion1 Nov 2028 (estimated)
- Study completion1 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TMJ DisorderStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Örebro University, Sweden
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07350239
- Sponsor's protocol ID
- 2024-00596-01
- Status last verified
- Jan 2026
- First submitted
- 7 Jan 2025
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Clinical, Microbial and Tissue-based Characterization Analyses of Severe Temporomandibular Joint Pathology
- ClinicalTrials.gov ID
- NCT07350239
- Acronym / sponsor ID
- 2024-00596-01
- Conditions
- TMJ Disorder, Ankylosis, Osteoarthritis
- Keywords
- TMJ, Temporomandibular joint, TMJ disorder, oral and maxillafacial surgery, TMJ pain, TMJ ankylosis, Severe osteoarthritis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Örebro University, SwedenUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 1 Nov 2028 (estimated)
- Study completion
- 1 Feb 2029 (estimated)
- First posted
- 20 Jan 2026 (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.
The general objective of this observational study is to clarify the clinical, microbial, and tissue characteristics, aetiology, and risk factors behind severe TMJ pathology. The main questions it aims to answer are:
- What are the clinical and histologic characteristics of patients with severe pathology of the TMJ?
- Can microbial DNA be found in TMJ tissue from patients with severe pathology of the TMJ, and if so, does this correlate to the outcome of the surgery?
Detailed description
The temporomandibular joint (TMJ) is a synovial joint characterized by a combination of rotation and translation during mouth opening. Unlike other joints in the body, the joint cartilage is fibrous and innervated by cranial nerves. Normal TMJ function is essential for vital functions such as eating, including proper mouth opening capacity, as well as for social activities such as talking, laughing, singing, and kissing. Several studies have reported a severe impact on the quality of life for patients with impaired and painful TMJ function.
Temporomandibular joint disorders (TMD) are common, affecting approximately 20% of the population with a strong, as yet unexplained, female predominance. The aetiology of internal derangement of the TMJ is unknown, but trauma and local or general joint hypermobility have been discussed as possible predisposing factors.
In a small proportion of patients, severe TMJ pathology, including ankylosis, develops. If ankylosis occurs, the condylar process of the mandible becomes fused to the fossa by fibrotic or bony tissue, resulting in severely restricted mouth opening ability. This can lead to a total inability to move the jaw, which can, in turn, be potentially life-threatening due to compromised airways in case of nausea.
In developing countries, TMJ ankylosis usually develops during early childhood as a complication of otitis media (inflammation of the middle ear). In the industrialized world, the condition is more frequent in adults. Factors suggested to cause severe TMJ disease, including ankylosis, are local or systemic infections or rheumatic diseases. According to some studies, a common etiological factor is trauma through intra-articular hematoma, tissue scarring, and excessive bone formation. Since most TMJ trauma resolves uneventfully, this does not explain the individual susceptibility to developing severe TMJ pathology. Thus, the aetiology and epidemiology of these conditions remain unknown.
Previous data point in different directions regarding the role of bacteria in TMJ pathology. However, knowledge regarding the role of chronic, low-virulent microbial challenges in post-surgically deteriorating cases with severe arthritis or ankylosis is lacking. Furthermore, the histopathologic presentation of these conditions is largely unknown, and systematic approaches for tissue categorization and diagnostics are lacking.
There are different surgical procedures available for these severe TMJ conditions, including osteoarthrectomy (removal of the joint bone), interpositional osteoarthrectomy using the temporalis muscle, and/or joint reconstruction using alloplastic materials or autogenous grafts. The choice of surgical technique is debated, and supporting long-term follow-up studies are lacking.
Previous studies have mainly focused on surgical interventions in a series of patients with TMJ disease without accounting for diagnosis or clinical presentation, leading to uncertainties regarding treatment decisions and efficacy. Knowledge of the mechanisms behind severe TMJ disease will improve the understanding, prediction, management, and prognosis of these conditions.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with TMJ ankylosis or severe osteoarthritis of TMJ. | – | Procedure: open TMJ surgery such as arthroplasty surgery with or without autogen or allogen reconstruction |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients (n=20) offered open TMJ surgery such as arthroplasty surgery with or without autogen or allogen reconstruction due to TMJ ankyloses or severe osteoarthritis. Patients treated at Karolinska University Hospital, Örebro University Hospital or Lund University Hospital. Exclusion criteria: suspicion of malignancy, inability to give consent.
Key inclusion criteria (2 listed)
- Patients subjected to open TMJ surgery such as arthroplastic surgery with or without autogen or allogen reconstruction
- Preserved biobank material (resected bone and soft tissue).
Key exclusion criteria (2 listed)
- Absence of biobank material.
- Inability to give informed consent.
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 |
|---|---|---|
| open TMJ surgery such as arthroplasty surgery with or without autogen or allogen reconstructionConsecutive patients (n=20) were offered open TMJ surgery, such as arthroplasty surgery with or without autogenous or allogenic reconstruction, due to TMJ ankylosis or severe osteoarthritis. The patients were treated at Karolinska University Hospital, Örebro University Hospital, or Lund University Hospital. | Procedure or surgery | Patients with TMJ ankylosis or severe osteoarthritis of TMJ. |
Primary outcome
Clinical investigation (patients):
Time frame: Inclusion will take at least 3 years, followed by one year of follow-up
Preoperatively, 1 week postoperatively, and at 1, 3, 6, and 12 months, or at the last visit after surgery, objective measures according to clinical routines for TMJ internal derangement patients will be collected. MRI and/or CBCT/CT will be performed preoperatively. Subjective measures include scoring functional severity and grading symptoms according to a 10-point visual analogue scale (VAS) in terms of pain intensity, functional disability, and psychosocial impact.
Questionnaires:
Time frame: Inclusion will take at least 3 years, followed by one year of follow-up.
Three questionnaires: Oral Health Impact Profile-14 (OHIP-14), Jaw Function Limitation Scale-8 (JFLS-8), and EuroQol-5D-5L will be distributed to the patients. The patients will complete the questionnaires at the first visit and at the one-year follow-up after surgery. All three questionnaires are validated and available in Swedish. OHIP-14: 14 questions answered on the scale: - Does not apply to me, Very often, Quite often, Sometimes, Rarely, Never. JFLS-8: 8 questions answered on the scale: - 0 (no limitation) up to 10 (major limitation). EuroQol-5D-5L: 5 questions, each with 5 options, that can be answered with: - Yes or No."
Histopathologic analyses:
Time frame: 3 years
Fresh specimens from resected TMJ tissue will be processed with formalin fixation (4%) for a minimum of 48 hours and sent to the Pathology department. The tissue will be decalcified with 7% formic acid for 2-4 weeks. The decision to arrest the decalcification process will depend on the softness of the tissue, which will be assessed by using the ability of a needle to transpierce the sample. Thereafter, the specimens will be dehydrated and paraffin-embedded according to routine procedures. For routine histological diagnoses, 3 μm thick sections will be stained with hematoxylin and eosin. Immunohistochemistry staining, as well as other complementary staining methods, will be performed using antibodies based on the results of the retrospective analyses. Part of the specimens will be fresh frozen. A specialist in pathology will review all the samples, categorize them, and assess them to identify any common denominators between the samples.
Analysis of microbial DNA in the Biobank material using 16S metagenomic sequencing
Time frame: 3 years
Microbial DNA analyses will be performed on formalin-fixed paraffin-embedded (FFPE) soft tissue specimens from the biobank. DNA will be purified using the QIAamp DNA FFPE Advanced UNG Kit (Qiagen) with an additional bead-beating step. The full-length 16S rRNA gene (variable V1-V9 regions) will be sequenced to identify the bacterial organisms at the species level. Amplification of the 16S rRNA gene (~1500bp) and library preparation will be performed using the 16S Barcoding Kit (Oxford Nanopore Technology, ONT), allowing multiplexing of samples and thereby reducing costs. Specialists in molecular biology and bioinformaticians will handle the results. Everything, from whether bacterial DNA is found to which different bacteria are present in what quantities, will be noted.
Objective & Subjective measurements
Time frame: Inclusion will take at least 3 years. Then one year follow up
Registration: (Specify in writing) * Past and current diseases * Medication * Medicational allergy Preoperative information registered at the initial visit: * TMJ trauma (yes/no) * TMJ dislocation (yes/no) * Parafunction (None/ Grinding/ Clenching) Preoperative Symptoms (Initial Visit, Subjective) * Crepitation: (Right/Left) * Clicking/Locking: (Right/Left) * Locking: (Right/Left) * Movement Pain: (Right/Left) * Restricted Mouth Opening: (Right/Left) * Difficulty Eating: (yes/no) * Difficulty Speaking: (yes/no) * Other: (write in text) Preoperative TMJ-Related Treatment * None * Conservative treatment: Bite splint, movement training, NSAIDs, bite correction, occlusal therapy * Corticosteroid injection * Arthrocentesis * Arthroscopy: Date (year \& which joint): * Open joint surgery: (If previous surgery, specify which and year) * Other treatments Surgery: * Surgical date * Age at surgery * Type of surgery * Surgical side (Right/left/bilateral)
Objective and subjective measurments
Time frame: Inclusion will take at least 3 years. Then one year follow up
The following measures will be recorded using the Visual Analog Scale (VAS) of 0-10: TMJ Pain During Function: * Measured on a scale from 0 to 10 for pain intensity. * Right/left TMJ will be assessed separately. * Time points: Preoperative, 1 month postoperative, 3 months postoperative, 6 months postoperative, 1 year postoperative, 2 years postoperative.
Objective and subjective measurments
Time frame: Inclusion will take at least 3 years. Then one year follow up
Palpation Tenderness Over the Temporomandibular Joints Laterally: * Scale: Yes/No for tenderness. * Right/Left TMJ. * Time points: Preoperative, 1 month postoperative, 3 months postoperative, 6 months postoperative, 1 year postoperative, 2 years postoperative. Palpation Tenderness Over the Masticatory Muscles (Pain Rating >2 on the Same Side): * Scale: Yes/No for tenderness. * Right/Left TMJ. * Time points: Preoperative, 1 month postoperative, 3 months postoperative, 6 months postoperative, 1 year postoperative, 2 years postoperative.
Objective and subjective measurments
Time frame: Inclusion will take at least 3 years. Then one year follow up
The following measures will be recorded using the Visual Analog Scale (VAS) of 0-10: Functional Impairment (Eating, Chewing, Biting) * Measured on a scale from 0 to 10 for difficulty in performing these functions. * Right/left TMJ will be assessed separately. * Time points: Preoperative, 1 month postoperative, 3 months postoperative, 6 months postoperative, 1 year postoperative, 2 years postoperative.
Objective and subjective measurments
Time frame: Inclusion will take at least 3 years. Then one year follow up
The following measures will be recorded using the Visual Analog Scale (VAS) of 0-10: Global Pain: * Measured on a scale from 0 to 10 for overall pain experience. * Time points: Preoperative, 1 month postoperative, 3 months postoperative, 6 months postoperative, 1 year postoperative, 2 years postoperative.
Objective and subjective measurments
Time frame: Inclusion will take at least 3 years. Then one year follow up
The following measures will be recorded using the Visual Analog Scale (VAS) of 0-10: Psycho-social Influence: * Measured on a scale from 0 to 10 for the psychological or social impact of pain and dysfunction. * Time points: Preoperative, 1 month postoperative, 3 months postoperative, 6 months postoperative, 1 year postoperative, 2 years postoperative.
Objective and subjective measurments
Time frame: Inclusion will take at least 3 years. Then one year follow up
Maximal Interincisal Opening: * Scale: Measured in millimeters. * Time points: Preoperative, 1 month postoperative, 3 months postoperative, 6 months postoperative, 1 year postoperative, 2 years postoperative. Maximal Lateral Movement (TMJ): * Measured in millimeters. * Right/Left TMJ. * Time points: Preoperative, 1 month postoperative, 3 months postoperative, 6 months postoperative, 1 year postoperative, 2 years postoperative.
2 secondary outcomes
Objective and subjective measurments
Time frame: Inclusion will take at least 3 years. Then one year follow up
Objective and subjective measurments
Time frame: Inclusion will take at least 3 years. Then one year follow up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of TMJ Disorder and Ankylosis, run by Örebro University, Sweden.
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 2 inclusion and 2 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: opening soon, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bodil Lund, Professor, senior OMFS (+46852488004, bodil.lund@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical investigation (patients): (time frame: Inclusion will take at least 3 years, followed by one year of follow-up). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jan 2026.