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Clinical Trials/NCT01903512
NCT01903512
Completed
Not Applicable

Arthrocentesis and Temporomandibular Joint Disorders a Conservative Alternative to Surgical Treatments

Università degli Studi di Sassari1 site in 1 country30 target enrollmentNovember 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
TMJ Internal Derangement
Sponsor
Università degli Studi di Sassari
Enrollment
30
Locations
1
Primary Endpoint
Pain decrease
Status
Completed
Last Updated
12 years ago

Overview

Brief Summary

This study aims to evaluate the efficacy of arthrocentesis in the treatment of internal derangement of the temporomandibular joint (TMJ).

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.

Registry
clinicaltrials.gov
Start Date
November 2010
End Date
May 2012
Last Updated
12 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Università degli Studi di Sassari
Responsible Party
Principal Investigator
Principal Investigator

Silvio Mario Meloni

DDS, PhD, Assistant Professor

Università degli Studi di Sassari

Eligibility Criteria

Inclusion Criteria

  • 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

Outcomes

Primary Outcomes

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.

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

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.

Secondary Outcomes

  • number of subjects showing signs of TMJ inflammation or structural alterations at Magnetic Resonance Imaging and Cone Beam Computerized Tomography pre- and postop.(Baseline (preop)- 60 days postop)

Study Sites (1)

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