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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Reza Tabrizi, Shiraz University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01958879
First received: October 5, 2013
Last updated: October 4, 2014
Last verified: October 2013
  Purpose

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 Intervention Phase
Temporomandibular Joint Dysfunction
Pain
Arthrocentesis
Drug: ringer with corticosteroid
Drug: ringer without corticosteroid
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Temporomandibular Disorder

Resource links provided by NLM:


Further study details as provided by Shiraz University of Medical Sciences:

Primary Outcome Measures:
  • pain [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Pain will be assessed preoperatively and again at 1 and 6 months using a visual analogue scale


Secondary Outcome Measures:
  • function [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Mouth opening was measured as the maximum interincisal distance in millimeters using a scale


Enrollment: 60
Study Start Date: September 2012
Study Completion Date: November 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   15 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01958879

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

No publications provided

Responsible Party: Reza Tabrizi, OMFS, Shiraz University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01958879     History of Changes
Other Study ID Numbers: 12345
Study First Received: October 5, 2013
Last Updated: October 4, 2014
Health Authority: Iran: Ethics Committee

Keywords provided by Shiraz University of Medical Sciences:
internal derangement,arthrocentesis,corticosteroid

Additional relevant MeSH terms:
Joint Diseases
Temporomandibular Joint Disorders
Temporomandibular Joint Dysfunction Syndrome
Craniomandibular Disorders
Jaw Diseases
Mandibular Diseases
Muscular Diseases
Musculoskeletal Diseases
Myofascial Pain Syndromes
Stomatognathic Diseases

ClinicalTrials.gov processed this record on November 24, 2014