NCT03675659

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Sep 2017

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 9, 2017

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 15, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 18, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

September 21, 2018

Status Verified

September 1, 2018

Enrollment Period

2.1 years

First QC Date

September 15, 2018

Last Update Submit

September 20, 2018

Conditions

Temporomandibular Joint DisordersTemporomandibular Sprain

Keywords

tmj pain

Outcome Measures

Primary Outcomes (1)

  • estimation of pain: Visual Analog Scale

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

    one year

Study Arms (2)

intra-articular injection

ACTIVE COMPARATOR

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

Drug: intra-articular injection

control

PLACEBO COMPARATOR

intra-articular injection with saline

Drug: intra-articular injection

Interventions

intra-articular injectionDRUG

intra-articular injection with magnesium sulfate with four injections at weekly intervals

Also known as: prolotherapy
controlintra-articular injection

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemales more affected than males
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atef

Giza, 12111, Egypt

RECRUITING

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Interventions

Injections, Intra-ArticularProlotherapy

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

InjectionsDrug Administration RoutesDrug TherapyTherapeuticsComplementary Therapies

Central Study Contacts

Atef A fouda, prof

CONTACT

01093440600atef.fouda@dentistry.cu.edu.eg

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
prof of maxillofacial surgery

Study Record Dates

First Submitted

September 15, 2018

First Posted

September 18, 2018

Study Start

September 9, 2017

Primary Completion

November 1, 2019

Study Completion

November 1, 2019

Last Updated

September 21, 2018

Record last verified: 2018-09

Locations

EG(1)