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

• ClinicalTrials.gov Identifier: NCT01958879
• Recruitment Status: Completed
• First Posted: October 9, 2013
• Last Update Posted: October 7, 2014
• Sponsor: Shiraz University of Medical Sciences
• Information provided by (Responsible Party): Reza Tabrizi, Shiraz University of Medical Sciences

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Temporomandibular Joint Dysfunction; Pain; Arthrocentesis	Drug: ringer with corticosteroid; Drug: ringer without corticosteroid	Phase 2

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Treatment of Temporomandibular Disorder
• Study Start Date: September 2012
• Actual Primary Completion Date: October 2013
• Actual Study Completion Date: November 2013

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. pain [ Time Frame: 6 months ]
   Pain will be assessed preoperatively and again at 1 and 6 months using a visual analogue scale

Secondary Outcome Measures :

1. function [ Time Frame: 6 months ]
   Mouth opening was measured as the maximum interincisal distance in millimeters using a scale

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

Iran, Islamic Republic of

Shiraz university of medical sciences

Shiraz, Iran, Islamic Republic of

Sponsors and Collaborators

Shiraz University of Medical Sciences

Investigators

• Study Chair: Reza Tabrizi, DMD; SUMS
• Study Director: Reza Tabrizi, DMD; SUMS
• Principal Investigator: Touba Karagah, DMD; SUMS

More Information

• Responsible Party: Reza Tabrizi, OMFS, Shiraz University of Medical Sciences
• ClinicalTrials.gov Identifier: NCT01958879
• Other Study ID Numbers: 12345
• First Posted: October 9, 2013
• Last Update Posted: October 7, 2014
• Last Verified: October 2013

Keywords provided by Reza Tabrizi, Shiraz University of Medical Sciences:

internal derangement,arthrocentesis,corticosteroid

Additional relevant MeSH terms:

Joint Diseases; Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome; Musculoskeletal Diseases; Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Muscular Diseases; Stomatognathic Diseases; Myofascial Pain Syndromes