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

Primary Purpose

Temporomandibular Joint Dysfunction, Pain, Arthrocentesis

Status
Completed
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
ringer with corticosteroid
ringer without corticosteroid
Sponsored by
Shiraz University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Temporomandibular Joint Dysfunction focused on measuring internal derangement,arthrocentesis,corticosteroid

Eligibility Criteria

15 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Shiraz university of medical sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ringer with corticosteroid

Ringer with out corticosteroid

Arm Description

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 .

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

Outcomes

Primary Outcome Measures

pain
Pain will be assessed preoperatively and again at 1 and 6 months using a visual analogue scale

Secondary Outcome Measures

function
Mouth opening was measured as the maximum interincisal distance in millimeters using a scale

Full Information

First Posted
October 5, 2013
Last Updated
October 4, 2014
Sponsor
Shiraz University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01958879
Brief Title
Efficacy of Arthrocentesis by Injection of Ringer With or Without Corticosteroid in Treatment of Internal Derangement
Official Title
Treatment of Temporomandibular Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shiraz University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporomandibular Joint Dysfunction, Pain, Arthrocentesis
Keywords
internal derangement,arthrocentesis,corticosteroid

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ringer with corticosteroid
Arm Type
Experimental
Arm Description
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 .
Arm Title
Ringer with out corticosteroid
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
ringer with corticosteroid
Intervention Description
200 mL Ringer solution+1mg dexamethasone after finishing the irrigation
Intervention Type
Drug
Intervention Name(s)
ringer without corticosteroid
Intervention Description
200 mL Ringer solution
Primary Outcome Measure Information:
Title
pain
Description
Pain will be assessed preoperatively and again at 1 and 6 months using a visual analogue scale
Time Frame
6 months
Secondary Outcome Measure Information:
Title
function
Description
Mouth opening was measured as the maximum interincisal distance in millimeters using a scale
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reza Tabrizi, DMD
Organizational Affiliation
SUMS
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Reza Tabrizi, DMD
Organizational Affiliation
SUMS
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Touba Karagah, DMD
Organizational Affiliation
SUMS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shiraz university of medical sciences
City
Shiraz
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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