Clinical Trial: Arthrocentesis and Temporomandibular Joint Disorders a Conservative Alternative to Surgical Treatments

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title:

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

Detailed Summary: 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.
Sponsor: Università degli Studi di Sassari

Current Primary Outcome:

  • 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.


Original Primary Outcome: Same as current

Current Secondary Outcome: 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.


Original Secondary Outcome: Same as current

Information By: Università degli Studi di Sassari

Dates:
Date Received: July 3, 2013
Date Started: November 2010
Date Completion:
Last Updated: July 16, 2013
Last Verified: July 2013