TMJ Disc DisorderNCT05510336
Assessment of Concentric Needle Technique in Temporomandibular Joint (TMJ) Internal Derangement.
A study testing Arthrocentesis in people with TMJ Disc Disorder, run by Cairo University.
Trial summary
The aim of the study is to evaluate the effectivenes of using two concentric needles in comaprsion with the normal traditional two distant needles. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- TMJ Disc Disorder
- What is being tested?
- Arthrocentesis
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2022to 1 Dec 2022
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with age ranges from 18-60.
- Patients with painful clicking.
- Patients free of systemic conditions that might affect the TMJ or interfere with carrying out the surgical procedure (osteoarthritis, rheumatoid arthritis, uncontrolled diabetes).
Who cannot join
- Patients out of the specified range group
- Patients with painless TMJ clicking.
- Patients with osteo-arthritic changes of the TMJ.
- Patients with systemic conditions that might affect the TMJ or interfere with carrying out the surgical procedure (osteoarthritis, rheumatoid arthritis, uncontrolled diabetes).
- Patients with previous TMJ surgeries.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Assessment of Concentric Needle Technique for the Management of Temporomandibular Joint Internal Derangement Randomized Controlled Trial (RCT)
The aim of the study is to evaluate the effectivenes of using two concentric needles in comaprsion with the normal traditional two distant needles.
- Conditions
- TMJ Disc Disorder
- Being tested
- Arthrocentesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArthrocentesisProcedure or surgery
Injection of lactated ringer solution in the TMJ to wash out inflammatory mediators and help reducing anterior disc displacement with reduction
| Study group | Role | What they receive |
|---|---|---|
| Study group | Active comparator | Concentric needle technique TMJ arthrocentesis using lactated ringer solution to help reduce inflammatory mediators and anterior disc discplacement with reduction Receives: Procedure: Arthrocentesis |
| Control group | Active comparator | Double needle technique TMJ arthrocentesis using lactated ringer solution to help reduce inflammatory mediators and anterior disc discplacement with reduction Receives: Procedure: Arthrocentesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain felt during the procedure TMJ arthrocentesis
Visual analogue scale from zero to ten (zero indicates no pain and ten indicates worst pain)
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2022
- Study start1 Sep 2022 (estimated)
- Primary completion1 Nov 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TMJ Disc DisorderStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Adel Hassan Mahmoud, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05510336
- Sponsor's protocol ID
- Concentric needle technique
- Status last verified
- Aug 2022
- First submitted
- 8 Aug 2022
- Last updated
- 22 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Concentric Needle Technique for the Management of Temporomandibular Joint Internal Derangement Randomized Controlled Trial (RCT)
- ClinicalTrials.gov ID
- NCT05510336
- Acronym / sponsor ID
- Concentric needle technique
- Conditions
- TMJ Disc Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (estimated)
- Primary completion
- 1 Nov 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 22 Aug 2022 (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.
The aim of the study is to evaluate the effectivenes of using two concentric needles in comaprsion with the normal traditional two distant needles.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Active comparator | Procedure: ArthrocentesisConcentric needle technique TMJ arthrocentesis using lactated ringer solution to help reduce inflammatory mediators and anterior disc discplacement with reduction |
| Control group | Active comparator | Procedure: ArthrocentesisDouble needle technique TMJ arthrocentesis using lactated ringer solution to help reduce inflammatory mediators and anterior disc discplacement with reduction |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients with age ranges from 18-60.
- Patients with painful clicking.
- Patients free of systemic conditions that might affect the TMJ or interfere with carrying out the surgical procedure (osteoarthritis, rheumatoid arthritis, uncontrolled diabetes).
Key exclusion criteria (5 listed)
- Patients out of the specified range group
- Patients with painless TMJ clicking.
- Patients with osteo-arthritic changes of the TMJ.
- Patients with systemic conditions that might affect the TMJ or interfere with carrying out the surgical procedure (osteoarthritis, rheumatoid arthritis, uncontrolled diabetes).
- Patients with previous TMJ surgeries.
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 |
|---|---|---|
| ArthrocentesisInjection of lactated ringer solution in the TMJ to wash out inflammatory mediators and help reducing anterior disc displacement with reduction | Procedure or surgery | Control group, Study group |
Primary outcome
Pain felt during the procedure TMJ arthrocentesis
Time frame: baseline
Visual analogue scale from zero to ten (zero indicates no pain and ten indicates worst pain)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2022.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Arthrocentesis in people with TMJ Disc Disorder, 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 3 inclusion and 5 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 22 Aug 2022. 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 Ahmed Adel, BDS Dentistry (01229530562, ahmed_adel@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 felt during the procedure TMJ arthrocentesis (time frame: baseline). 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 22 Aug 2022.