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Arthrocentesis and Temporomandibular Joint Disorders a Conservative Alternative to Surgical Treatments

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ClinicalTrials.gov Identifier: NCT01903512
Recruitment Status : Completed
First Posted : July 19, 2013
Last Update Posted : July 19, 2013
Sponsor:
Information provided by (Responsible Party):
Silvio Mario Meloni, Università degli Studi di Sassari

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
TMJ Internal Derangement 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.

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Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Case-Only
Time Perspective: Prospective
Study Start Date : November 2010
Actual Primary Completion Date : March 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine


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)




Primary Outcome Measures :
  1. 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.

  2. 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

  3. 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 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. [ 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.



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Ages Eligible for Study:   25 Years to 62 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01903512


Locations
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Italy
Maxillofacial Unit, University of Sassari
Sassari, SS,, Italy, 07100
Sponsors and Collaborators
Università degli Studi di Sassari
Investigators
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Principal Investigator: Silvio M Meloni, assist prof University of Sassari, Italy

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Silvio Mario Meloni, DDS, PhD, Assistant Professor, Università degli Studi di Sassari
ClinicalTrials.gov Identifier: NCT01903512     History of Changes
Other Study ID Numbers: IT010713
First Posted: July 19, 2013    Key Record Dates
Last Update Posted: July 19, 2013
Last Verified: July 2013

Keywords provided by Silvio Mario Meloni, Università degli Studi di Sassari:
TMJ arthrocentesis
internal derangement
conservative treatment

Additional relevant MeSH terms:
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Temporomandibular Joint Disorders
Temporomandibular Joint Dysfunction Syndrome
Craniomandibular Disorders
Mandibular Diseases
Jaw Diseases
Musculoskeletal Diseases
Joint Diseases
Muscular Diseases
Stomatognathic Diseases
Myofascial Pain Syndromes