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Completed

NCT Number: NCT01903512

Arthrocentesis and Temporomandibular Joint Disorders a Conservative Alternative to Surgical Treatments

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

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Key information

Conditions

TMJ Internal Derangement

Age range

25 year–62 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Maxillofacial Unit, University of Sassari

Sassari, SS,, 07100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TMJ Arthrocentesis

Procedure

lavage of the superior TMJ space with saline and sodium hyaluronate (SH)

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Università degli Studi di Sassari

Other

Registry information

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jul 19, 2013
Registry last updated
Jul 19, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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