Arthrocentesis and Temporomandibular Joint Disorders a Conservative Alternative to Surgical Treatments

NCT01903512 | Completed

• 1 other identifier: IT010713
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

TMJ Internal Derangement

Keywords

TMJ arthrocentesis; internal derangement; conservative treatment

Outcome Measures

Primary Outcomes (3)

• Pain decrease

  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.

  baseline (preop), 1 week, 1 month, 2 months, 6 months, 12 months (postop)

• increase in the mouth opening

  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

  Baseline (preop), 1 week, 1 month, 2 months, 6 months, 12 months (postop)

• TMJ click and noises reduction

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

  Baseline (preop), 12 months (postop)

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.

  Baseline (preop)- 60 days postop

Study Arms (1)

arthrocentesis in TMJ internal derangement

30 patients with TMJ internal derangement and pain with history of failed conservative management.

Procedure: TMJ arthrocentesis

Interventions

TMJ arthrocentesis PROCEDURE

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

arthrocentesis in TMJ internal derangement

Eligibility Criteria

• Age: 25 Years - 62 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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).

You may qualify if:

• TMJ pain
• TMJ noises and click
• history of unsuccessful conservative management (NSAID and occlusal bite)
• occlusal bite still present

You may not qualify if:

• degenerative joint disease (such as osteoarthritis, rheumatoid arthritis etc.)
• history of condylar fractures or previous TMJ trauma
• TMJ surgery

Sponsors & Collaborators

• Università degli Studi di Sassari: lead

Study Sites (1)

Maxillofacial Unit, University of Sassari

Sassari, SS,, 07100, Italy

Location

Related Publications (1)

• De Riu G, Stimolo M, Meloni SM, Soma D, Pisano M, Sembronio S, Tullio A. Arthrocentesis and temporomandibular joint disorders: clinical and radiological results of a prospective study. Int J Dent. 2013;2013:790648. doi: 10.1155/2013/790648. Epub 2013 Nov 11.

  PMID: 24319462 DERIVED

MeSH Terms

Interventions

Arthrocentesis

Intervention Hierarchy (Ancestors)

Paracentesis; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Therapeutics; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Silvio M Meloni, assist prof

  Università degli Studi di Sassari

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DDS, PhD, Assistant Professor

Study Record Dates

• First Submitted: July 3, 2013
• First Posted: July 19, 2013
• Study Start: November 1, 2010
• Primary Completion: March 1, 2012
• Study Completion: May 1, 2012
• Last Updated: July 19, 2013

Record last verified: 2013-07

Locations

IT (1)