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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

Tracking Information
First Submitted Date  ICMJE September 15, 2018
First Posted Date  ICMJE September 18, 2018
Last Update Posted Date September 21, 2018
Actual Study Start Date  ICMJE September 9, 2017
Estimated Primary Completion Date November 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 17, 2018)
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
Original Primary Outcome Measures  ICMJE
 (submitted: September 17, 2018)
estimation of pain: VAS [ Time Frame: one year ]
VAS pain measurement
Change History Complete list of historical versions of study NCT03675659 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intra-articular Magnesium Sulfate for Tmj Dysfunction
Official Title  ICMJE Effect of Magnesium Sulfate on Pain and Clicking Sound on Patients With Temporomandibular Joint Dysfunction
Brief Summary mixing the magnesium sulfate with dextrose for management of tmj pain will be studied using intra-articular injection of the solution
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Temporomandibular Joint Disorders
  • Temporomandibular Sprain
Intervention  ICMJE Drug: intra-articular injection
intra-articular injection with magnesium sulfate with four injections at weekly intervals
Other Name: prolotherapy
Study Arms  ICMJE
  • Active Comparator: intra-articular injection
    intra-articular injection with magnesium sulfate at weekly interval for four weeks
    Intervention: Drug: intra-articular injection
  • Placebo Comparator: control
    intra-articular injection with saline
    Intervention: Drug: intra-articular injection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 17, 2018)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2019
Estimated Primary Completion Date November 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: females more affected than males
Ages  ICMJE 20 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Atef A fouda, prof 01093440600 ext 002 atef.fouda@dentistry.cu.edu.eg
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03675659
Other Study ID Numbers  ICMJE CD5618
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Atef Fouda, Cairo University
Study Sponsor  ICMJE Cairo University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Cairo University
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP