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Intra-articular Magnesium Sulfate for Tmj Dysfunction

Primary Purpose

Temporomandibular Joint Disorders, Temporomandibular Sprain

Status
Unknown status
Phase
Early Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
intra-articular injection
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Temporomandibular Joint Disorders focused on measuring tmj pain

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • healthy females-no treatment received within the last 6 months-accept treatment protocol

Exclusion Criteria:

  • unco-operative patients-patients with auto-immune diseases-patients diagnosed with arthritis

Sites / Locations

  • AtefRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

intra-articular injection

control

Arm Description

intra-articular injection with magnesium sulfate at weekly interval for four weeks

intra-articular injection with saline

Outcomes

Primary Outcome Measures

estimation of pain: Visual Analog Scale
Visual Analog Scale pain measurement with "0" indicates no pain and "100" the maximum pain felt ever

Secondary Outcome Measures

Full Information

First Posted
September 15, 2018
Last Updated
September 20, 2018
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT03675659
Brief Title
Intra-articular Magnesium Sulfate for Tmj Dysfunction
Official Title
Effect of Magnesium Sulfate on Pain and Clicking Sound on Patients With Temporomandibular Joint Dysfunction
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 9, 2017 (Actual)
Primary Completion Date
November 2019 (Anticipated)
Study Completion Date
November 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
mixing the magnesium sulfate with dextrose for management of tmj pain will be studied using intra-articular injection of the solution

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporomandibular Joint Disorders, Temporomandibular Sprain
Keywords
tmj pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
intra-articular injection
Arm Type
Active Comparator
Arm Description
intra-articular injection with magnesium sulfate at weekly interval for four weeks
Arm Title
control
Arm Type
Placebo Comparator
Arm Description
intra-articular injection with saline
Intervention Type
Drug
Intervention Name(s)
intra-articular injection
Other Intervention Name(s)
prolotherapy
Intervention Description
intra-articular injection with magnesium sulfate with four injections at weekly intervals
Primary Outcome Measure Information:
Title
estimation of pain: Visual Analog Scale
Description
Visual Analog Scale pain measurement with "0" indicates no pain and "100" the maximum pain felt ever
Time Frame
one year

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
females more affected than males
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: healthy females-no treatment received within the last 6 months-accept treatment protocol Exclusion Criteria: unco-operative patients-patients with auto-immune diseases-patients diagnosed with arthritis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Atef A fouda, prof
Phone
01093440600
Ext
002
Email
atef.fouda@dentistry.cu.edu.eg
Facility Information:
Facility Name
Atef
City
Giza
ZIP/Postal Code
12111
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
atef fouda, prof
Phone
01224316042

12. IPD Sharing Statement

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Intra-articular Magnesium Sulfate for Tmj Dysfunction

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