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Intra-articular Magnesium Sulfate for Tmj Dysfunction

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ClinicalTrials.gov Identifier: NCT03675659
Recruitment Status : Recruiting
First Posted : September 18, 2018
Last Update Posted : September 21, 2018
Sponsor:
Information provided by (Responsible Party):
Atef Fouda, Cairo University

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

Condition or disease Intervention/treatment Phase
Temporomandibular Joint Disorders Temporomandibular Sprain Drug: intra-articular injection Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Effect of Magnesium Sulfate on Pain and Clicking Sound on Patients With Temporomandibular Joint Dysfunction
Actual Study Start Date : September 9, 2017
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine


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 Name: 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 Name: prolotherapy




Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   females more affected than males
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03675659


Contacts
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Contact: Atef A fouda, prof 01093440600 ext 002 atef.fouda@dentistry.cu.edu.eg

Locations
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Egypt
Atef Recruiting
Giza, Egypt, 12111
Contact: atef fouda, prof    01224316042      
Sponsors and Collaborators
Cairo University

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Responsible Party: Atef Fouda, prof of maxillofacial surgery, Cairo University
ClinicalTrials.gov Identifier: NCT03675659     History of Changes
Other Study ID Numbers: CD5618
First Posted: September 18, 2018    Key Record Dates
Last Update Posted: September 21, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Atef Fouda, Cairo University:
tmj pain
Additional relevant MeSH terms:
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Joint Diseases
Temporomandibular Joint Disorders
Temporomandibular Joint Dysfunction Syndrome
Musculoskeletal Diseases
Craniomandibular Disorders
Mandibular Diseases
Jaw Diseases
Muscular Diseases
Stomatognathic Diseases
Myofascial Pain Syndromes
Magnesium Sulfate
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Anti-Arrhythmia Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Tocolytic Agents
Reproductive Control Agents