NCT Number: NCT07350239
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?
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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:
JFLS-8: 8 questions answered on the scale:
EuroQol-5D-5L: 5 questions, each with 5 options, that can be answered with:
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.
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.
Time frame: Inclusion will take at least 3 years. Then one year follow up
Registration:
(Specify in writing)
Preoperative information registered at the initial visit:
Preoperative Symptoms (Initial Visit, Subjective)
Preoperative TMJ-Related Treatment
Surgery:
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:
Time frame: Inclusion will take at least 3 years. Then one year follow up
Palpation Tenderness Over the Temporomandibular Joints Laterally:
Palpation Tenderness Over the Masticatory Muscles (Pain Rating >2 on the Same Side):
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)
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:
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:
Time frame: Inclusion will take at least 3 years. Then one year follow up
Maximal Interincisal Opening:
Maximal Lateral Movement (TMJ):
Time frame: Inclusion will take at least 3 years. Then one year follow up
Occlusal Relationships:
Time frame: Inclusion will take at least 3 years. Then one year follow up
Postoperative Complications
Contact information is provided by the study sponsor or research team.
Bodil Lund, Professor, senior OMFS
CONTACT
Nikoo Bazsefidpay, DDS, OMF Consultant, PHD
CONTACT
Örebro University, Sweden
Other
Prospective Clinical, Microbial and Tissue-based Characterization Analyses of Severe Temporomandibular Joint Pathology
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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