Intra-articular Magnesium Sulfate for Tmj Dysfunction

September 20, 2018 updated by: Atef Fouda, Cairo University

Effect of Magnesium Sulfate on Pain and Clicking Sound on Patients With Temporomandibular Joint Dysfunction

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Giza, Egypt, 12111
        • Recruiting
        • Atef
        • Contact:
          • atef fouda, prof
          • Phone Number: 01224316042

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: intra-articular injection
intra-articular injection with magnesium sulfate at weekly interval for four weeks
Drug: intra-articular injection
intra-articular injection with magnesium sulfate with four injections at weekly intervals
Other Names:
  • prolotherapy
Placebo Comparator: control
intra-articular injection with saline
Drug: intra-articular injection
intra-articular injection with magnesium sulfate with four injections at weekly intervals
Other Names:
  • prolotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
estimation of pain: Visual Analog Scale
Time Frame: one year
Visual Analog Scale pain measurement with "0" indicates no pain and "100" the maximum pain felt ever
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 9, 2017

Primary Completion (Anticipated)

November 1, 2019

Study Completion (Anticipated)

November 1, 2019

Study Registration Dates

First Submitted

September 15, 2018

First Submitted That Met QC Criteria

September 17, 2018

First Posted (Actual)

September 18, 2018

Study Record Updates

Last Update Posted (Actual)

September 21, 2018

Last Update Submitted That Met QC Criteria

September 20, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CD5618

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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