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Arthrocentesis and Temporomandibular Joint Disorders a Conservative Alternative to Surgical Treatments

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01903512
Enrollment
30
Registered
2013-07-19
Start date
2010-11-30
Completion date
2012-05-31
Last updated
2013-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

TMJ Internal Derangement

Keywords

TMJ arthrocentesis, internal derangement, conservative treatment

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.

Interventions

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

Sponsors

Università degli Studi di Sassari
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
25 Years to 62 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Pain decreasebaseline (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 openingBaseline (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 reductionBaseline (preop), 12 months (postop)At the end of 1 year, (75%) patients stated no evidence of clicking.

Secondary

MeasureTime frameDescription
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 postop40% 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.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 22, 2026