Arthrocentesis and Temporomandibular Joint Disorders a Conservative Alternative to Surgical Treatments

July 16, 2013 updated by: Silvio Mario Meloni, Università degli Studi di Sassari
This study aims to evaluate the efficacy of arthrocentesis in the treatment of internal derangement of the temporomandibular joint (TMJ).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This work was designed as a prospective case series clinical study. Patients imaging was evaluated with Cone-Beam Computed Tomography and Nuclear Magnetic Resonance at the beginning of the treatment and after the last arthrocentesis.

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • SS,
      • Sassari, SS,, Italy, 07100
        • Maxillofacial Unit, University of Sassari

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 62 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

A total of 30 patients with TMJ internal derangement and pain with history of failed conservative management were selected. 70% had anteriorly displaced discs (AD), and 30 complained of other disorders (osteophytes, signs of soft tissues inflammmation, TMJ structure alterations).

Description

Inclusion Criteria:

  • TMJ pain
  • TMJ noises and click
  • history of unsuccessful conservative management (NSAID and occlusal bite)
  • occlusal bite still present

Exclusion Criteria:

  • degenerative joint disease (such as osteoarthritis, rheumatoid arthritis etc.)
  • history of condylar fractures or previous TMJ trauma
  • TMJ surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
arthrocentesis in TMJ internal derangement
30 patients with TMJ internal derangement and pain with history of failed conservative management.
Procedure: TMJ arthrocentesis
lavage of the superior TMJ space with saline and sodium hyaluronate (SH)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain decrease
Time Frame: baseline (preop), 1 week, 1 month, 2 months, 6 months, 12 months (postop)
Patients were followed up for 1 year. The mean pre-operative pain, using visual analog scale, showed an average decrease of 6.7 at 1 year.
baseline (preop), 1 week, 1 month, 2 months, 6 months, 12 months (postop)
increase in the mouth opening
Time Frame: Baseline (preop), 1 week, 1 month, 2 months, 6 months, 12 months (postop)
The mean maximum mouth opening(MMO) pre-operatively was 15,8 mm and increased to 34 mm immediately following arthrocentesis which increased by 0.5-1 mm at every month followup with mean MMO of 39,4 mm at 6 months. Thereafter it remained consistent till 1 year. The mean increase in the mouth opening at 1 year was 23,6 mm
Baseline (preop), 1 week, 1 month, 2 months, 6 months, 12 months (postop)
TMJ click and noises reduction
Time Frame: Baseline (preop), 12 months (postop)
At the end of 1 year, (75%) patients stated no evidence of clicking.
Baseline (preop), 12 months (postop)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of subjects showing signs of TMJ inflammation or structural alterations at Magnetic Resonance Imaging and Cone Beam Computerized Tomography pre- and postop.
Time Frame: Baseline (preop)- 60 days postop
40% of subjects who showed clear signs of inflammation showed significant improvement, in 30% with structural alterations was evident the absence of intra-articular adhesions and debris, in 30% with internal derangement did not appear any radiographic change.
Baseline (preop)- 60 days postop

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Università degli Studi di Sassari

Investigators

  • Principal Investigator: Silvio M Meloni, assist prof, University of Sassari, Italy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

July 3, 2013

First Submitted That Met QC Criteria

July 16, 2013

First Posted (Estimate)

July 19, 2013

Study Record Updates

Last Update Posted (Estimate)

July 19, 2013

Last Update Submitted That Met QC Criteria

July 16, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IT010713

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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