Temporomandibular Joint DisordersEarly Phase 1NCT03675659
Intra-articular Magnesium Sulfate for Tmj Dysfunction
A Early Phase 1 study testing intra-articular injection in people with Temporomandibular Joint Disorders and Temporomandibular Sprain, run by Cairo University at 1 site in Egypt.
Trial summary
mixing the magnesium sulfate with dextrose for management of tmj pain will be studied using intra-articular injection of the solution Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Temporomandibular Joint Disorders, Temporomandibular Sprain
- What is being tested?
- intra-articular injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 9 Sep 2017to Nov 2019
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy females-no treatment received within the last 6 months-accept treatment protocol
Who cannot join
- unco-operative patients-patients with auto-immune diseases-patients diagnosed with arthritis
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Atef
Giza, 12111
atef fouda, prof, 01224316042
About this study
Official title: 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
- Being tested
- intra-articular injection
- Keywords
- tmj pain
- Medical subject headings
- Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intra-articular injectionDrug
Also called prolotherapy
intra-articular injection with magnesium sulfate with four injections at weekly intervals
| Study group | Role | What they receive |
|---|---|---|
| intra-articular injection | Active comparator | intra-articular injection with magnesium sulfate at weekly interval for four weeks Receives: Drug: intra-articular injection |
| control | Placebo comparator | intra-articular injection with saline Receives: Drug: intra-articular injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
estimation of pain: Visual Analog Scale
Visual Analog Scale pain measurement with "0" indicates no pain and "100" the maximum pain felt ever
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2018
- Study start9 Sep 2017
- Primary completionNov 2019 (estimated)
- Study completionNov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular Joint DisordersStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Atef Fouda, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03675659
- Sponsor's protocol ID
- CD5618
- Status last verified
- Sep 2018
- First submitted
- 15 Sep 2018
- Last updated
- 21 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Magnesium Sulfate on Pain and Clicking Sound on Patients With Temporomandibular Joint Dysfunction
- ClinicalTrials.gov ID
- NCT03675659
- Acronym / sponsor ID
- CD5618
- Keywords
- tmj pain
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 9 Sep 2017 (actual)
- Primary completion
- Nov 2019 (estimated)
- Study completion
- Nov 2019 (estimated)
- First posted
- 18 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
mixing the magnesium sulfate with dextrose for management of tmj pain will be studied using intra-articular injection of the solution
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intra-articular injection | Active comparator | Drug: intra-articular injectionintra-articular injection with magnesium sulfate at weekly interval for four weeks |
| control | Placebo comparator | Drug: intra-articular injectionintra-articular injection with saline |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy females-no treatment received within the last 6 months-accept treatment protocol
Key exclusion criteria (1 listed)
- unco-operative patients-patients with auto-immune diseases-patients diagnosed with arthritis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intra-articular injectionAlso: prolotherapyintra-articular injection with magnesium sulfate with four injections at weekly intervals | Drug | control, intra-articular injection |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing intra-articular injection in people with Temporomandibular Joint Disorders and Temporomandibular Sprain, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Atef A fouda, prof (01093440600 ext. 002, atef.fouda@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
estimation of pain: Visual Analog Scale (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2018; AzTrials last refreshed its copy on 30 Oct 2026.