TMJ - Oral &Maxillofacial SurgeryNCT06205667
Computer Guided Versus Conventional Arthrocentesis in Management of Internal Derangements: A Randomized Clinical Study
A study testing Computer Guided Arthrocentesis and Conventional Arthrocentesis in people with TMJ - Oral &Maxillofacial Surgery, run by Ain Shams University at 1 site in Egypt.
Trial summary
The aim of the study is to evaluate the applicability, accuracy, benefits and the efficacy of 3-dimensional, printed, patient-specific guides to direct TMJ access for arthrocentesis when performed in contrast with conventional arthrocentesis of TMJ. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- TMJ - Oral &Maxillofacial Surgery
- What is being tested?
- Computer Guided Arthrocentesis and Conventional Arthrocentesis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2021to 30 Sep 2023
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients who complain from signs and symptoms of internal derangements and were diagnosed by the RDC/TMD as having disc displacement with/ without reduction with / without limitation associated with arthralgia or as having disc displacement with reduction associated with arthralgia in a presence or absence of joint sounds.
- Patients who did not responded to conservative treatment for a minimum of 3 months.
- Obtaining written informed consents signed by the patients.
Who cannot join
- Patients suffering from any muscular disorders as myofascial pain or myofascial pain with limitations
- If the disc was not visible in the MRI examination.
- Patients who previously received intra-articular injection of any medication or exposed to any other TMJ invasive procedure.
- Patients who suffer from any connective tissue diseases as rheumatoid arthritis or neurologic disorders.
- Patients with history of major jaw trauma, bisphosphonate-derived drug use, pregnancy, alcohol or drug dependence.
- Patients with gross mechanical restrictions or history of adhesion (fibrous or bony).
- Patients with psychiatric disease or substance abuse or have an allergy to the substance used in the study.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the study is to evaluate the applicability, accuracy, benefits and the efficacy of 3-dimensional, printed, patient-specific guides to direct TMJ access for arthrocentesis when performed in contrast with conventional arthrocentesis of TMJ.
- Conditions
- TMJ - Oral &Maxillofacial Surgery
- Being tested
- Computer Guided Arthrocentesis, Conventional Arthrocentesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer Guided ArthrocentesisProcedure or surgery
patients are going to be injected intra-articular within the superior joint space of the affected TMJ through custom guided template planned in a manner inspired by earphone design to get support from the tragus.
Conventional ArthrocentesisProcedure or surgery
patients are going to be injected intra-articular within the superior joint space of the affected TMJ using conventional method anatomical landmark determination
| Study group | Role | What they receive |
|---|---|---|
| Computer Guided Arthrocentesis | Experimental | a study group injected intra-articularly through TMJ using a computer-guided template. Receives: Procedure: Computer Guided Arthrocentesis |
| Conventional Arthrocentesis | Active comparator | a control group which injected intra-articular through TMJ using conventional method based on anatomical landmark determination Receives: Procedure: Conventional Arthrocentesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attempts number of needle puncture
Measured: intraoperative
Operation time started from first needle insertion.
Measured: intaoperative
Secondary outcomes (2)
Maximum mouth opening
Change of mouth opening measurement using RDC/TMD
Measured: 1week, 1, 3 and 6
Pain reduction
Pain assessment using Visual analogue Scale
Measured: 1week, 1, 3 and 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2024
- Study start1 Jun 2021
- Primary completion1 Mar 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TMJ - Oral &Maxillofacial SurgeryStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06205667
- Sponsor's protocol ID
- FD-ASU-RCC.IM022204
- Status last verified
- Mar 2021
- First submitted
- 4 Jan 2024
- Last updated
- 16 Jan 2024
- 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 16 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computer Guided Versus Conventional Arthrocentesis in Management of Internal Derangements: A Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT06205667
- Acronym / sponsor ID
- FD-ASU-RCC.IM022204
- Conditions
- TMJ - Oral &Maxillofacial Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 16 Jan 2024 (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 applicability, accuracy, benefits and the efficacy of 3-dimensional, printed, patient-specific guides to direct TMJ access for arthrocentesis when performed in contrast with conventional arthrocentesis of TMJ.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Computer Guided Arthrocentesis | Experimental | Procedure: Computer Guided Arthrocentesisa study group injected intra-articularly through TMJ using a computer-guided template. |
| Conventional Arthrocentesis | Active comparator | Procedure: Conventional Arthrocentesisa control group which injected intra-articular through TMJ using conventional method based on anatomical landmark determination |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients who complain from signs and symptoms of internal derangements and were diagnosed by the RDC/TMD as having disc displacement with/ without reduction with / without limitation associated with arthralgia or as having disc displacement with reduction associated with arthralgia in a presence or absence of joint sounds.
- Patients who did not responded to conservative treatment for a minimum of 3 months.
- Obtaining written informed consents signed by the patients.
Key exclusion criteria (7 listed)
- Patients suffering from any muscular disorders as myofascial pain or myofascial pain with limitations
- If the disc was not visible in the MRI examination.
- Patients who previously received intra-articular injection of any medication or exposed to any other TMJ invasive procedure.
- Patients who suffer from any connective tissue diseases as rheumatoid arthritis or neurologic disorders.
- Patients with history of major jaw trauma, bisphosphonate-derived drug use, pregnancy, alcohol or drug dependence.
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 |
|---|---|---|
| Computer Guided Arthrocentesispatients are going to be injected intra-articular within the superior joint space of the affected TMJ through custom guided template planned in a manner inspired by earphone design to get support from the tragus. | Procedure or surgery | Computer Guided Arthrocentesis |
| Conventional Arthrocentesispatients are going to be injected intra-articular within the superior joint space of the affected TMJ using conventional method anatomical landmark determination | Procedure or surgery | Conventional Arthrocentesis |
Primary outcome
Attempts number of needle puncture
Time frame: intraoperative
Operation time started from first needle insertion.
Time frame: intaoperative
2 secondary outcomes
Maximum mouth opening
Time frame: 1week, 1, 3 and 6
Pain reduction
Time frame: 1week, 1, 3 and 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2024.
Related trials for TMJ - Oral &Maxillofacial Surgery
RecruitingObservational study
Exploration of the Utility of Dental-dedicated MRI for Dentistry
Dental Crowding, Dental Occlusion, Traumatic
RecruitingPhase 3
Biologic Augmentation of TMJ Arthroscopy Using BMAC
TMJ - Oral &Maxillofacial Surgery, Oral and Maxillofacial Conditions
Not yet recruiting
Temporomandibular Disorder (TMD) Diagnostic Concordance Between Physiotherapist and Surgeon
Temporo-mandibular Dysfunction, Temporomandibular Disorder (TMD)
Enrolling by invitationObservational study
Arthroscopic Anterior Release Versus Discectomy as Treatments for Temporomandibular Joint Disc Displacement With Reduction
TMJ - Injury of Meniscus of Temporomandibular Joint, TMD
RecruitingPhase 3
Art-Based Pain Assessment Tool in Patients With Temporomandibular Joint Disorders
Temporomandibular Disorders (TMD), Wilkes 1 and 2
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computer Guided Arthrocentesis and Conventional Arthrocentesis in people with TMJ - Oral &Maxillofacial Surgery, run by Ain Shams 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 3 inclusion and 7 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: finished, as of the sponsor's last update on 16 Jan 2024. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Attempts number of needle puncture (time frame: intraoperative). 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 16 Jan 2024.