Arthroscopy of the Temporomandibular Joint. On Jaw Mobility, Pain and HRQoL

NCT06433154 | Completed

• 1 other identifier: 230_20211018_073
• Study Type: observational
• Target: 127
• Locations: 1 country
• Sites: 2

Brief Summary

The aim of the present study is to retrospectively investigate whether arthroscopic treatment in patients with TMD symptoms depending on internal derangement of the temporomandibular joint (TMJ) gives a satisfying result on the patient's quality of life. Based on previous studies it is hypothesized that patients suffering from TMD depending on internal derangement would through Patient Reported Outcome Measures (PROM) evaluate the treatment efficacy from an arthroscopic treatment as a benefit to their quality of life. Further, the study intends to find out if the patient reported outcome measures (PROM) on health-related quality of life (HRQoL) outcome correlates with clinical follow-up measures after arthroscopic treatment of internal derangement of the temporomandibular joint. The primary objective is to measure the correlation between the results from a HRQoL questionnaire and mouth opening. Secondary, the effect of mouth opening on HRQoL is being explored. The primary prediction variable is the surgical treatment. Outcome variables are treatment evaluation quality of life (PROM) based on a validated questionnaire; Jaw Functional Limitation Scale (JFLS), age, gender, time from diagnosis to treatment, severity of symptoms (pain, mouth opening ability) and time from treatment to evaluation.

Conditions

Arthroscopic Surgery; Temporomandibular Joint; Health-Related Quality Of Life; Follow-Up Studies; Observational

Keywords

Arthroscopy; TMJ; PROM; HRQoL

Outcome Measures

Primary Outcomes (1)

• Jaw mobility

  Measured range of mandibular movements.

  At least one year follow-up after surgery.

Secondary Outcomes (1)

• Health Related Quality of Life (HRQoL)

  At least one year follow-up after surgery.

Study Arms (1)

Arthroscopic surgery to the temporomandibular joint

Arthroscopic lysis and lavage in patients with internal derangement of the temporomandibular joint. Retrospective observational follow-up cohort trial.

Procedure: Arthroscopic surgery

Interventions

Arthroscopic surgery PROCEDURE

Arthroscopic treatment (lysis and lavage) of internal derangement of the temporomandibular joint.

Arthroscopic surgery to the temporomandibular joint

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients which had surgical treatment, were anterior disc displacement combined with pain or "Closed Lock" (disc displacement without reduction). Patients aged over 20.

You may qualify if:

• Patients referred to the Department of Oral and Maxillofacial Surgery, Lund University Hospital between 2006 to 2019 with a temporomandibular dysfunction presenting painful clicking or locking of the TMJ and has underwent an arthroscopic treatment the TMJ on one side.
• Patients aged over 20.

You may not qualify if:

• Patients with only muscular or mainly muscular originated TMJ symptoms. Present generalized joint disease, previous surgical treatment in the TMJ, less than 12 months of follow up time and patients which have had additional surgical treatment during the study period.

Sponsors & Collaborators

• Lund University Hospital: lead

Study Sites (2)

Dept Oral and Maxillofacial Surgery

Lund, 22185, Sweden

Location

Martin Bengtsson

Lund, 22350, Sweden

Location

Related Publications (1)

• Bengtsson M, Fransson P. Do patient-reported outcome measures correlate with clinical follow-up after arthroscopic treatment of internal derangement of the temporomandibular joint? J Stomatol Oral Maxillofac Surg. 2021 Sep;122(4):e21-e26. doi: 10.1016/j.jormas.2021.03.003. Epub 2021 Apr 9.

  PMID: 33845189 BACKGROUND

MeSH Terms

Interventions

Arthroscopy

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Orthopedic Procedures

Study Officials

• Martin Bengtsson, DDS, PhD

  Lund University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2024
• First Posted: May 29, 2024
• Study Start: March 1, 2023
• Primary Completion: December 31, 2023
• Study Completion: March 30, 2024
• Last Updated: May 29, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

SE (2)