Clinical, Microbial and Tissue-based Characterization of Patients Treated for Severe Temporomandibular Joint Pathology

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorÖrebro University, Sweden

About this trial

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?

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

Absence of biobank material.

Inability to give informed consent.

Trial 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.

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • open TMJ surgery such as arthroplasty surgery with or without autogen or allogen reconstruction

    Procedure/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.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Patients with TMJ ankylosis or severe osteoarthritis of TMJ.1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Inclusion will take at least 3 years, followed by one year of follow-up
2

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."

Time frame
Inclusion will take at least 3 years, followed by one year of follow-up.
3

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.

Time frame
3 years
4

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.

Time frame
3 years

Secondary outcomes

1

Objective and subjective measurments

Occlusal Relationships: * Written description of the occlusal relationship. * Time points: Preoperative and 1 year postoperative

Time frame
Inclusion will take at least 3 years. Then one year follow up
2

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).

Time frame
Inclusion will take at least 3 years. Then one year follow up

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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