Arthrocentesis and Temporomandibular Joint Disorders a Conservative Alternative to Surgical Treatments

Sponsor
Università degli Studi di Sassari (Other)
Overall Status
Completed
CT.gov ID
NCT01903512
Collaborator
(none)
30
1
18
1.7

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: TMJ arthrocentesis

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 Design

Study Type:
Observational
Actual Enrollment :
30 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Study Start Date :
Nov 1, 2010
Actual Primary Completion Date :
Mar 1, 2012
Actual Study Completion Date :
May 1, 2012

Arms and Interventions

Arm 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)

Outcome Measures

Primary Outcome Measures

  1. Pain decrease [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.

  2. increase in the mouth opening [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

  3. TMJ click and noises reduction [Baseline (preop), 12 months (postop)]

    At the end of 1 year, (75%) patients stated no evidence of clicking.

Secondary Outcome Measures

  1. 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]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
25 Years to 62 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Maxillofacial Unit, University of Sassari Sassari SS, Italy 07100

Sponsors and Collaborators

  • Università degli Studi di Sassari

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Silvio Mario Meloni, DDS, PhD, Assistant Professor, Università degli Studi di Sassari
ClinicalTrials.gov Identifier:
NCT01903512
Other Study ID Numbers:
  • IT010713
First Posted:
Jul 19, 2013
Last Update Posted:
Jul 19, 2013
Last Verified:
Jul 1, 2013
Keywords provided by Silvio Mario Meloni, DDS, PhD, Assistant Professor, Università degli Studi di Sassari

Study Results

No Results Posted as of Jul 19, 2013