Arthrocentesis and Temporomandibular Joint Disorders a Conservative Alternative to Surgical Treatments

Completed

• Conditions: TMJ Internal Derangement

• Registration Number: NCT01903512
• Lead Sponsor: 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).

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 Timeline

• Study Start: 2010-11
• Primary Completion: 2012-03
• Study Completion: 2012-05
• Status Verified: 2013-07
• Study First Submitted: 2013-07-03
• Study First Submitted QC: 2013-07-16
• Last Update Submitted: 2013-07-16
• Study First Posted: 2013-07-19
• Last Update Posted: 2013-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.
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
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Maxillofacial Unit, University of Sassari; 🇮🇹 Sassari, SS,, Italy