Arthrocentesis and Temporomandibular Joint Disorders a Conservative Alternative to Surgical Treatments
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|ClinicalTrials.gov Identifier: NCT01903512|
Recruitment Status : Completed
First Posted : July 19, 2013
Last Update Posted : July 19, 2013
|Condition or disease||Intervention/treatment|
|TMJ Internal Derangement||Procedure: TMJ arthrocentesis|
|Study Type :||Observational|
|Actual Enrollment :||30 participants|
|Study Start Date :||November 2010|
|Actual Primary Completion Date :||March 2012|
|Actual Study Completion Date :||May 2012|
arthrocentesis in TMJ internal derangement
30 patients with TMJ internal derangement and pain with history of failed conservative management.
Procedure: TMJ arthrocentesis
lavage of the superior TMJ space with saline and sodium hyaluronate (SH)
- 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.
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01903512
|Maxillofacial Unit, University of Sassari|
|Sassari, SS,, Italy, 07100|
|Principal Investigator:||Silvio M Meloni, assist prof||University of Sassari, Italy|