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

NCT07350239 | Not Yet Recruiting

• 1 other identifier: 2024-00596-01
• Study Type: observational
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief 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 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?

Conditions

Osteoarthritis; TMJ Disorder; Ankylosis

Keywords

TMJ; Temporomandibular joint; TMJ disorder; oral and maxillafacial surgery; TMJ pain; TMJ ankylosis; Severe osteoarthritis

Outcome Measures

Primary Outcomes (11)

• 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.

  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."

  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.

  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.

  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)

  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.

  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.

  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.

  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.

  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.

  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.

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

Secondary Outcomes (2)

• Objective and subjective measurments

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

• Objective and subjective measurments

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

Study Arms (1)

Patients with TMJ ankylosis or severe osteoarthritis of TMJ.

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

Interventions

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

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.

Patients with TMJ ankylosis or severe osteoarthritis of TMJ.

Eligibility Criteria

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

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.

You may qualify if:

• 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).

You may not qualify if:

• Absence of biobank material.
• Inability to give informed consent.

Sponsors & Collaborators

• Örebro University, Sweden: lead

Biospecimen

Retention: SAMPLES WITH DNA

Microbial DNA analysis will be executed on both soft tissue samples and fresh frozen bone tissue. (16S rRNA Sequencing)

MeSH Terms

Conditions

Temporomandibular Joint Disorders; Ankylosis; Osteoarthritis; Temporomandibular ankylosis

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases; Arthritis; Rheumatic Diseases

Central Study Contacts

Bodil Lund, Professor, senior OMFS

CONTACT

+46852488004; bodil.lund@ki.se

Nikoo Bazsefidpay, DDS, OMF Consultant, PHD

CONTACT

+46739697323; nikoo.bazsefidpay@regionorebrolan.se

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2025
• First Posted: January 20, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): February 1, 2029
• Last Updated: January 20, 2026

Record last verified: 2026-01