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

NCT ID: NCT01958879

Last Updated: 2014-10-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2013-11-30

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.

Conditions

Temporomandibular Joint Dysfunction; Pain; Arthrocentesis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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 .

Group Type: EXPERIMENTAL

ringer with corticosteroid

Intervention Type: DRUG

200 mL Ringer solution+1mg dexamethasone after finishing the irrigation

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

Group Type: PLACEBO_COMPARATOR

ringer without corticosteroid

Intervention Type: DRUG

200 mL Ringer solution

Interventions

ringer with corticosteroid

200 mL Ringer solution+1mg dexamethasone after finishing the irrigation

Intervention Type: DRUG

ringer without corticosteroid

200 mL Ringer solution

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shiraz University of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Reza Tabrizi

OMFS

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Reza Tabrizi, DMD

Role: STUDY_CHAIR

SUMS

Reza Tabrizi, DMD

Role: STUDY_DIRECTOR

SUMS

Touba Karagah, DMD

Role: PRINCIPAL_INVESTIGATOR

SUMS

Locations

Shiraz university of medical sciences

Shiraz, , Iran

Countries

Iran

Other Identifiers

12345

Identifier Type: -

Identifier Source: org_study_id