Trials / Completed
CompletedNCT01958879
Efficacy of Arthrocentesis by Injection of Ringer With or Without Corticosteroid in Treatment of Internal Derangement
Treatment of Temporomandibular Disorder
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 60 (actual)
- Sponsor
- Shiraz University of Medical Sciences · Academic / Other
- Sex
- All
- Age
- 15 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
The study aims to evaluate effectiveness of ringer injection with or without corticosteroid during arthrocentesis of the temporomandibular joint in the treatment of internal derangement of the temporomandibular joint (TMJ).
Detailed description
This prospective clinical study was approved by Local ethical committee and written informed consent will be obtained before the trial starts. Criteria for selection of the patients was based on history and clinical findings characteristic of internal derangement. All these patients were initially treated with NSAIDS for 1 week and occlusal splints for 1 month had failed to respond to these conservative treatments. The patients with systemic problems which affect bone and joints,psychological problems ,history of maxillofacial fractures and orthognathic surgery were excluded from the study. A total of 60 patients with TMJ internal derangement with failed conservative management, were subjected to TMJ arthrocentesis. All arthrocentesis were performed by the same maxillofacial surgeon. Subjects were randomly allocated into two groups (30 cases in each group). Subjects in the group 1 received irrigation with Ringer solution and in the group 2 ,subjects underwent irrigation with Ringer solution with corticosteroid (Dexamethasone ) .Two examiners evaluated Temporomandibular disorder's signs ( mouth opening,click , crepitus and pain) before, one month and 6 months after arthrocentesis.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ringer with corticosteroid | 200 mL Ringer solution+1mg dexamethasone after finishing the irrigation |
| DRUG | ringer without corticosteroid | 200 mL Ringer solution |
Timeline
- Start date
- 2012-09-01
- Primary completion
- 2013-10-01
- Completion
- 2013-11-01
- First posted
- 2013-10-09
- Last updated
- 2014-10-07
Locations
1 site across 1 country: Iran
Source: ClinicalTrials.gov record NCT01958879. Inclusion in this directory is not an endorsement.