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

Pain Clinical Trial

Official title:

Treatment of Temporomandibular Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01958879
• Other study ID #: 12345
• Status: Completed
• Phase: Phase 2
• First received: October 5, 2013
• Last updated: October 4, 2014
• Start date: September 2012
• Est. completion date: November 2013

Study information

• Verified date: October 2013
• Source: Shiraz University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthrocentesis
• Joint Diseases
• Pain
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction
• Temporomandibular Joint Dysfunction Syndrome

Intervention

Drug:
• ringer with corticosteroid
200 mL Ringer solution+1mg dexamethasone after finishing the irrigation
• ringer without corticosteroid
200 mL Ringer solution

Locations

Country	Name	City	State
Iran, Islamic Republic of	Shiraz university of medical sciences	Shiraz

Sponsors (1)

Lead Sponsor	Collaborator
Shiraz University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain	Pain will be assessed preoperatively and again at 1 and 6 months using a visual analogue scale	6 months	No
Secondary	function	Mouth opening was measured as the maximum interincisal distance in millimeters using a scale	6 months	No