Efficacy of Arthrocentesis by Injection of Ringer With or Without Corticosteroid in Treatment of Internal Derangement

Phase 2

Completed

• Conditions: Temporomandibular Joint Dysfunction; Pain; Arthrocentesis
• Interventions: Drug: ringer with corticosteroid; Drug: ringer without corticosteroid

• Registration Number: NCT01958879
• Lead Sponsor: Shiraz University of Medical Sciences

Brief 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.

Study Timeline

• Study Start: 2012-09
• Status Verified: 2013-10
• Primary Completion: 2013-10
• Study First Submitted: 2013-10-05
• Study First Submitted QC: 2013-10-05
• Study First Posted: 2013-10-09
• Study Completion: 2013-11
• Last Update Submitted: 2014-10-04
• Last Update Posted: 2014-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Patients with clinical findings characteristic of internal derangement(clicking and joint pain lasting for more than 6 months) unilaterally or bilaterally and history of previous conservative drug therapy (NSAIDs and Muscle relaxant ),splint therapy and physiotherapy without improvement.
• Patients of both sexes between 15 to 80 year's old
• Patients who are willing for evaluation in 1 and 6 months after arthrocentesis
• Patients who are provided written consent form

Exclusion Criteria

• Patient had systemic problems which affect bone and joints disease
• Patient with psychological problems
• Patient with history of maxillofacial fractures and orthognathic
• Patients who can not continue the study for private or social reasons

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ringer with corticosteroid	ringer with corticosteroid	Intra-articular irrigation was performed under local anesthesia with subcutaneous injection of 1%lidocaine solution (0.6 to 0.9 mL anaesthetic solution )was injected to block the auriculotemporal nerve. Then the skin on the TMJ was penetrated with a 21-gauge needle at the articular fossa followed by the injection of 3 mL Ringer solution to distend the joint space, pumping it in and out repeatedly. Another 21-gauge needle was inserted into the distended compartment in the area of the articular eminence, and the superior joint space was irrigated with 200 mL Ringer solution, allowing a free flow through the first needle in the both groups .In this group patients received 1mg dexamethasone after finishing the irrigation .
Ringer with out corticosteroid	ringer without corticosteroid	Intra-articular irrigation was performed under local anesthesia with subcutaneous injection of 1%lidocaine solution (0.6 to 0.9 mL anaesthetic solution )was injected to block the auriculotemporal nerve. Then the skin on the TMJ was penetrated with a 21-gauge needle at the articular fossa followed by the injection of 3 mL Ringer solution to distend the joint space, pumping it in and out repeatedly. Another 21-gauge needle was inserted into the distended compartment in the area of the articular eminence, and the superior joint space was irrigated with 200 mL Ringer solution, allowing a free flow through the first needle in the both groups

Primary Outcome Measures

Name	Time	Method
pain	6 months	Pain will be assessed preoperatively and again at 1 and 6 months using a visual analogue scale

Secondary Outcome Measures

Name	Time	Method
function	6 months	Mouth opening was measured as the maximum interincisal distance in millimeters using a scale

Trial Locations

Locations (1)

Shiraz university of medical sciences; 🇮🇷 Shiraz, Iran, Islamic Republic of