TMJ DisorderarthroscopyNCT06473376
Comparison Between Hegab Splint, Arthrocentesis, and Arthroscopy in Treatment of TMJ Closed Lock
A study testing arthrocentesis in people with TMJ Disorder and TMJ Disc Disorder, run by Al-Azhar University at 2 sites in Egypt.
Trial summary
This prospective, randomized control study aimed to compare the Clinical Outcome of Hegab splint, Arthrocentesis, and Arthroscopy in treatment of TMJ closed lock. The study sample was derived from the population of patients who presented for evaluation and treatment of TMJ disorders. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- TMJ Disorder, TMJ Disc Disorder
- What is being tested?
- arthrocentesis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 2 sitesEgypt
- Study dates
- 14 Jan 2020to 30 Dec 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
- No healthy volunteers
- Adult
Who may be able to join
- Patients with TMJ closed lock confirmed
Who cannot join
- rheumatoid arthritis psoriatic arthritis juvenile arthritis those receiving anticoagulant therapy
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Comparison Between of Hegab Splint, Arthrocentesis, and Arthroscopy in Treatment of TMJ Closed Lock
This prospective, randomized control study aimed to compare the Clinical Outcome of Hegab splint, Arthrocentesis, and Arthroscopy in treatment of TMJ closed lock. The study sample was derived from the population of patients who presented for evaluation and treatment of TMJ disorders.
Read the detailed description
This prospective, randomized control study aimed to compare the Clinical Outcome of Hegab splint, Arthrocentesis, and Arthroscopy in treatment of TMJ closed lock. The study sample was derived from the population of patients who presented for evaluation and treatment of TMJ disorders. The patients were randomly assigned to one of the following three groups: Group I (Control): patients treated by Hegab splint. Group II: patients treated by arthrocentesis with injection of HA/PRP mix plus Hegab splint. Group III: arthroscopy with injection of HA/PRP mix plus Hegab splint. The primary outcome variable was the change in pain using a visual analog scale, and improvement of maximum voluntary mouth opening. The secondary outcome variable was the change in joint sound. The third category of variables (age and sex) was evaluated in relation to the outcomes.
- Conditions
- TMJ Disorder, TMJ Disc Disorder
- Being tested
- arthrocentesis
- 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.
arthrocentesisProcedure or surgery
Also called arthroscopy
TMJ arthrocentesis and arthroscopy
| Study group | Role | What they receive |
|---|---|---|
| Group I (Control) | Other | Hegab TMJ splint Receives: Procedure: arthrocentesis |
| Group II | Other | arthrocentesis Receives: Procedure: arthrocentesis |
| GROUP III | Other | arthroscopy Receives: Procedure: arthrocentesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in pain using a visual analog scale,
The primary outcome variable was the change in pain using a visual analog scale (VAS), with 0 indicating the absence of pain and 10 indicating the worst pain possible
Measured: one year
improvement of maximum voluntary mouth opening
improvement of maximum voluntary (non-assisted) mouth opening (MVMO) in millimetres.
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 posted25 Jun 2024
- Study start14 Jan 2020
- Primary completion30 Jul 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TMJ DisorderStudies of the same condition, open and under way.
- More trials run by Al-Azhar 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
- Model description
- The patients were randomly assigned to one of the following three groups: Group I (Control): patients treated by Hegab splint. Group II: patients treated by arthrocentesis with injection of HA/PRP mix plus Hegab splint. Group III: arthroscopy with injection of HA/PRP mix plus Hegab splint. The primary outcome variable was the change in pain using a visual analog scale, and improvement of maximum voluntary mouth opening. The secondary outcome variable was the change in joint sound. The third category of variables (age and sex) was evaluated in relation to the outcomes
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayman Hegab, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06473376
- Sponsor's protocol ID
- AUAREC20200503-8
- Acronym
- arthroscopy
- Status last verified
- Jun 2024
- First submitted
- 18 Jun 2024
- Last updated
- 25 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between of Hegab Splint, Arthrocentesis, and Arthroscopy in Treatment of TMJ Closed Lock
- ClinicalTrials.gov ID
- NCT06473376
- Acronym / sponsor ID
- arthroscopy / AUAREC20200503-8
- Conditions
- TMJ Disorder, TMJ Disc Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 14 Jan 2020 (actual)
- Primary completion
- 30 Jul 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 25 Jun 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.
This prospective, randomized control study aimed to compare the Clinical Outcome of Hegab splint, Arthrocentesis, and Arthroscopy in treatment of TMJ closed lock. The study sample was derived from the population of patients who presented for evaluation and treatment of TMJ disorders.
Detailed description
This prospective, randomized control study aimed to compare the Clinical Outcome of Hegab splint, Arthrocentesis, and Arthroscopy in treatment of TMJ closed lock. The study sample was derived from the population of patients who presented for evaluation and treatment of TMJ disorders. The patients were randomly assigned to one of the following three groups: Group I (Control): patients treated by Hegab splint. Group II: patients treated by arthrocentesis with injection of HA/PRP mix plus Hegab splint. Group III: arthroscopy with injection of HA/PRP mix plus Hegab splint. The primary outcome variable was the change in pain using a visual analog scale, and improvement of maximum voluntary mouth opening. The secondary outcome variable was the change in joint sound. The third category of variables (age and sex) was evaluated in relation to the outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- The patients were randomly assigned to one of the following three groups: Group I (Control): patients treated by Hegab splint. Group II: patients treated by arthrocentesis with injection of HA/PRP mix plus Hegab splint. Group III: arthroscopy with injection of HA/PRP mix plus Hegab splint. The primary outcome variable was the change in pain using a visual analog scale, and improvement of maximum voluntary mouth opening. The secondary outcome variable was the change in joint sound. The third category of variables (age and sex) was evaluated in relation to the outcomes
| Arm | Type | Receives |
|---|---|---|
| Group I (Control) | Other | Procedure: arthrocentesisHegab TMJ splint |
| Group II | Other | Procedure: arthrocentesisarthrocentesis |
| GROUP III | Other | Procedure: arthrocentesisarthroscopy |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients with TMJ closed lock confirmed
Key exclusion criteria (1 listed)
- rheumatoid arthritis psoriatic arthritis juvenile arthritis those receiving anticoagulant therapy
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 |
|---|---|---|
| arthrocentesisAlso: arthroscopyTMJ arthrocentesis and arthroscopy | Procedure or surgery | GROUP III, Group I (Control), Group II |
Primary outcome
change in pain using a visual analog scale,
Time frame: one year
The primary outcome variable was the change in pain using a visual analog scale (VAS), with 0 indicating the absence of pain and 10 indicating the worst pain possible
improvement of maximum voluntary mouth opening
Time frame: one year
improvement of maximum voluntary (non-assisted) mouth opening (MVMO) in millimetres.
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 25 Jun 2024.
- Individual participant dataSharing planned: No
Related trials for TMJ Disorder
Not yet recruiting
Comparing Dextrose Prolotherapy vs. Sodium Hyaluronic Acid Injections for Jaw Joint Internal Derangement
Temporomandibular Joint Internal Derangement, TMJ-ID
Recruiting
Machine Learning for Evaluating and Diagnosing Temporomandibular Disorders
Temporomandibular Disorders (TMD), TMJ Disorder
Not yet recruiting
Comparison of Conventional,3D Printed and Novel Hybrid Stabilization Splints in the Management of Temporomandibular Joint Disorders
Temporomandibular Disorders (TMDs), Myofascial Pain - Dysfunction Syndrome of TMJ
Enrolling by invitationObservational study
Autologous Exosomes From Platelet-rich Plasma as a Modern Tool of Regenerative Dentistry
Temporomandibular Disorders (TMD), Muscle Pain
Not yet recruiting
Arthroscopic Lysis and Lavage With and Without Intra-articular Injection of Hyaluronic Acid in Patients With DDwoR in TMJ
TMJ Disc Disorder, Temporomandibular Joint Disc Displacement, Without Reduction
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing arthrocentesis in people with TMJ Disorder and TMJ Disc Disorder, run by Al-Azhar University at 2 sites 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: finished, as of the sponsor's last update on 25 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
change in pain using a visual analog scale, (time frame: one year). 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 25 Jun 2024; AzTrials last refreshed its copy on 6 Nov 2026.