TMJ PainNCT04212975
Arthrocentesis Followed by Prolotherapy
A study testing joint lavage with dextrose in people with TMJ Pain, run by Cairo University.
Trial summary
we will do tmj joint lavage and followed by dextrose injection Read more about this study
- Who is it for?
- Ages 19 to 36 years, women only
- Conditions the study is for
- TMJ Pain
- What is being tested?
- joint lavage with dextrose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 8 Jan 2020to 30 Apr 2020
- Phase
- Interventional
- 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 19 to 36 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- tmj painful joints patients healthy patients disk displacement with reduction
Who cannot join
- patients previously treated males young age group
Trial locations and contacts
No sites are listed yet.
About this study
Official title: TMJ Lavage Followed by Dextrose Prolotherapy
we will do tmj joint lavage and followed by dextrose injection
Read the detailed description
Two groups of patients one group will receive lavage with saline and other group will receive lavage then dextrose injection
- Conditions
- TMJ Pain
- Being tested
- joint lavage with dextrose
- Keywords
- tmj, pain
- Medical subject headings
- Temporomandibular Joint Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
joint lavage with dextroseOther
joint lavage with dextrose
| Study group | Role | What they receive |
|---|---|---|
| group 1 | Experimental | lavage by dextrose Receives: Other: joint lavage with dextrose |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain scores
Change in pain symptoms measured by visual analogue scale 1=better-to-10 worse
Measured: 3 months
Maximum mouth opening measured in millimeter 36mm=normal, less than 36mm=worse
Change in mouth opening- decrease =worse
Measured: 3 months
Secondary outcomes (1)
Change in pain symptoms measured by visual analogue scale
Measurement of change in pain scores from 1-10, 1=better-to-10 worse
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2019
- Study start8 Jan 2020 (estimated)
- Primary completion31 Mar 2020 (estimated)
- Study completion30 Apr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TMJ PainStudies 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
- Phase N/A
- Primary purpose
- Treatment
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Atef Fouda, Cairo University
- Investigators
- Atef Abd El H Fouda, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04212975
- Sponsor's protocol ID
- Cairo University-11022
- Status last verified
- Dec 2019
- First submitted
- 15 Dec 2019
- Last updated
- 2 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TMJ Lavage Followed by Dextrose Prolotherapy
- ClinicalTrials.gov ID
- NCT04212975
- Acronym / sponsor ID
- Cairo University-11022
- Conditions
- TMJ Pain
- Keywords
- tmj, pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 8 Jan 2020 (estimated)
- Primary completion
- 31 Mar 2020 (estimated)
- Study completion
- 30 Apr 2020 (estimated)
- First posted
- 30 Dec 2019 (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.
we will do tmj joint lavage and followed by dextrose injection
Detailed description
Two groups of patients one group will receive lavage with saline and other group will receive lavage then dextrose injection
Study design
- Primary purpose
- Treatment
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| group 1 | Experimental | Other: joint lavage with dextroselavage by dextrose |
Who may qualify
- Ages
- 19 to 36 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- tmj painful joints patients healthy patients disk displacement with reduction
Key exclusion criteria (1 listed)
- patients previously treated males young age group
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 |
|---|---|---|
| joint lavage with dextrosejoint lavage with dextrose | Other | group 1 |
Primary outcome
pain scores
Time frame: 3 months
Change in pain symptoms measured by visual analogue scale 1=better-to-10 worse
Maximum mouth opening measured in millimeter 36mm=normal, less than 36mm=worse
Time frame: 3 months
Change in mouth opening- decrease =worse
1 secondary outcome
Change in pain symptoms measured by visual analogue scale
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2020.
- Individual participant dataSharing planned: No
Related trials for TMJ Pain
Recruiting
R01_Pilot Jaw Muscle Phenotypes
Chronic TMD Pain, Temporomandibular Disorder
Recruiting
Evaluation of the Effect of Adding Sodium Bicarbonate to Lidocaine in the Treatment of Myofascial Pain Syndrome
Myofacial Pain, Myofacial Pain Syndrome
Recruiting
An Open Label Study Assessing REN Treatment in Headache Management in Temporomandibular Disorders
Temporomandibular Disorder, Orofacial Pain
Recruiting
Machine Learning for Evaluating and Diagnosing Temporomandibular Disorders
Temporomandibular Disorders (TMD), TMJ Disorder
RecruitingObservational study
Masticatory Muscle Activity Using a 24-Hour Wearable Device
Chronic Masticatory Myofascial Pain
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.
Atef Abd El H Fouda principal investigator
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing joint lavage with dextrose in people with TMJ Pain, run by Cairo University.
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 2 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 Abd El H Fouda (+201093440600, 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?
pain scores (time frame: 3 months). The study lists 2 primary outcomes in all. 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 2 Jan 2020.