TMJ Internal Derangement Clinical Trial
| Verified date | July 2013 |
| Source | Università degli Studi di Sassari |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Italy: Ministry of Health |
| Study type | Observational |
This study aims to evaluate the efficacy of arthrocentesis in the treatment of internal derangement of the temporomandibular joint (TMJ).
| Status | Completed |
| Enrollment | 30 |
| Est. completion date | May 2012 |
| Est. primary completion date | March 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 25 Years to 62 Years |
| Eligibility |
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 |
Observational Model: Case-Only, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Italy | Maxillofacial Unit, University of Sassari | Sassari | SS, |
| Lead Sponsor | Collaborator |
|---|---|
| Università degli Studi di Sassari |
Italy,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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) | No |
| Primary | 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) | No |
| Primary | TMJ click and noises reduction | At the end of 1 year, (75%) patients stated no evidence of clicking. | Baseline (preop), 12 months (postop) | No |
| Secondary | number of subjects showing signs of TMJ inflammation or structural alterations at Magnetic Resonance Imaging and Cone Beam Computerized Tomography pre- and 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. | Baseline (preop)- 60 days postop | No |