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

Treatment of Temporomandibular Disorder

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).

Study Overview

• Status: Completed
• Conditions: Pain; Temporomandibular Joint Dysfunction; Arthrocentesis
• Intervention / Treatment: Drug: ringer with corticosteroid; Drug: ringer without corticosteroid

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Shiraz, Iran, Islamic Republic of
    • Shiraz University of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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 .	Drug: ringer with corticosteroid; 200 mL Ringer solution+1mg dexamethasone after finishing the irrigation
Placebo Comparator: Ringer with out 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	Drug: ringer without corticosteroid; 200 mL Ringer solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain	Pain will be assessed preoperatively and again at 1 and 6 months using a visual analogue scale	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
function	Mouth opening was measured as the maximum interincisal distance in millimeters using a scale	6 months

Collaborators and Investigators

• Sponsor: Shiraz University of Medical Sciences
• Investigators: Study Chair: Reza Tabrizi, DMD, SUMS; Study Director: Reza Tabrizi, DMD, SUMS; Principal Investigator: Touba Karagah, DMD, SUMS

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): November 1, 2013

Study Registration Dates

• First Submitted: October 5, 2013
• First Submitted That Met QC Criteria: October 5, 2013
• First Posted (Estimate): October 9, 2013

Study Record Updates

• Last Update Posted (Estimate): October 7, 2014
• Last Update Submitted That Met QC Criteria: October 4, 2014
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Keywords: internal derangement,arthrocentesis,corticosteroid
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Muscular Diseases; Stomatognathic Diseases; Jaw Diseases; Craniomandibular Disorders; Mandibular Diseases; Myofascial Pain Syndromes; Joint Diseases; Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome
• Other Study ID Numbers: 12345 (Danish Center for Healthcare Improvements)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No