Temporomandibular Joint Internal DerangementNCT07316673
A Prospective Randomized Clinical Trial Comparing a Fast-Fix-Enhanced Arthroscopic System Versus Conventional Arthroscopic Suturing for Temporomandibular Disc Repositioning in Internal Derangement: Functional, Clinical, and Surgical Outcomes
A study testing Fast-Fix-Enhanced Arthroscopic and (Conventional Arthroscopic Suturing Disc Repositioning) in people with Temporomandibular Joint Internal Derangement, run by Cairo University.
Trial summary
This prospective randomized clinical trial evaluates the effectiveness of a Fast Fix-enhanced arthroscopic system compared with conventional arthroscopic suturing for temporomandibular joint disc repositioning in patients with TMJ internal derangement. Read more about this study
- Who is it for?
- Ages 15 to 75 years
- Conditions the study is for
- Temporomandibular Joint Internal Derangement
- What is being tested?
- Fast-Fix-Enhanced Arthroscopic and (Conventional Arthroscopic Suturing Disc Repositioning)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Jan 2026to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 15 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age ≥ 18 years.
- Both sexes.
- Patients with TMJ internal derangement (disc displacement without reduction).
- Patients indicated for arthroscopic disc repositioning following failure of conservative management.
Who cannot join
- Previous TMJ surgery on the affected joint.
- Rheumatoid arthritis, systemic inflammatory joint disease, or other TMJ pathology (tumor, fracture, infection)
- Severe degenerative joint disease (osteoarthritis grade V) or ankylosis.
- Patients are unable to comply with follow-up assessments or MRI evaluation.
- Patients with TMDS are secondary to malocclusion.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Prospective Randomized Clinical Trial Comparing a Fast Fix Enhanced Arthroscopic System Versus Conventional Arthroscopic Suturing for Temporomandibular Disc Repositioning in Internal Derangement: Clinical, Functional, and Surgical Outcomes
This prospective randomized clinical trial evaluates the effectiveness of a Fast Fix-enhanced arthroscopic system compared with conventional arthroscopic suturing for temporomandibular joint disc repositioning in patients with TMJ internal derangement. Patients are randomly allocated into two groups and assessed for functional improvement (maximum mouth opening), pain reduction, joint symptoms, and surgical performance outcomes over a 6-month follow-up period. The study aims to determine whether the Fast Fix-enhanced technique provides superior clinical, functional, and surgical outcomes compared to conventional arthroscopic suturing
- Being tested
- Fast-Fix-Enhanced Arthroscopic, (Conventional Arthroscopic Suturing Disc Repositioning)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fast-Fix-Enhanced ArthroscopicProcedure or surgery
Device: The FasT-Fix system is a medical device designed for an "all-inside" arthroscopic meniscal repair.
(Conventional Arthroscopic Suturing Disc Repositioning)Procedure or surgery
Arthroscopic TMJ discopexy using conventional suturing
Minimally invasive surgical intervention
| Study group | Role | What they receive |
|---|---|---|
| Fast-Fix-Enhanced Arthroscopic Disc Repositioning | Experimental | Not described Receives: Procedure: Fast-Fix-Enhanced Arthroscopic |
| Conventional Arthroscopic Suturing Disc Repositioning | Active comparator | Not described Receives: Procedure: (Conventional Arthroscopic Suturing Disc Repositioning) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional improvement assessed by Maximum Mouth Opening (MIO)
MIO is measured as the maximal interincisal distance (in millimeters) using a ruler or digital caliper, with the primary endpoint being the change from baseline to 6 months postoperatively.
Measured: Baseline (preoperative) to 6 months postoperatively (with assessments at 3 months and 6 months; primary endpoint at 6 months
Secondary outcomes (4)
Clinical outcomes , Pain reduction assessed using the Visual Analogue Scale (VAS) • Improvement of joint symptoms, including clicking and tenderness.
Pain intensity assessed using the 10-cm Visual Analogue Scale (VAS), where 0 represents no pain and 10 represents unbearable pain.
Measured: Baseline (preoperative), 3 months, and 6 months postoperatively
Joint Symptoms (Clicking and Tenderness)
Clinical evaluation of TMJ joint sounds (clicking) and joint tenderness through physical examination and patient report.
Measured: Baseline (preoperative), 3 months, and 6 months postoperatively
Surgical outcomes Total surgical time recorded
Total surgical time recorded intraoperatively from incision to completion of disc fixation, measured in minutes
Measured: Intraoperative (day of procedure only)
surgical outcomes Technical Feasibility
Surgeon's intraoperative assessment of the feasibility of disc fixation using the assigned arthroscopic technique.
Measured: Intraoperative (day of procedure only)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2026
- Study startJan 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular Joint Internal DerangementStudies 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
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wajmah Sayed Karim Al Sayed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07316673
- Sponsor's protocol ID
- Fast-Fix-Enhanced Arthroscopic
- Status last verified
- Dec 2025
- First submitted
- 19 Dec 2025
- Last updated
- 6 Jan 2026
- 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 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Clinical Trial Comparing a Fast Fix Enhanced Arthroscopic System Versus Conventional Arthroscopic Suturing for Temporomandibular Disc Repositioning in Internal Derangement: Clinical, Functional, and Surgical Outcomes
- ClinicalTrials.gov ID
- NCT07316673
- Acronym / sponsor ID
- Fast-Fix-Enhanced Arthroscopic
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jan 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 5 Jan 2026 (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 clinical trial evaluates the effectiveness of a Fast Fix-enhanced arthroscopic system compared with conventional arthroscopic suturing for temporomandibular joint disc repositioning in patients with TMJ internal derangement. Patients are randomly allocated into two groups and assessed for functional improvement (maximum mouth opening), pain reduction, joint symptoms, and surgical performance outcomes over a 6-month follow-up period. The study aims to determine whether the Fast Fix-enhanced technique provides superior clinical, functional, and surgical outcomes compared to conventional arthroscopic suturing
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fast-Fix-Enhanced Arthroscopic Disc Repositioning | Experimental | Procedure: Fast-Fix-Enhanced Arthroscopic |
| Conventional Arthroscopic Suturing Disc Repositioning | Active comparator | Procedure: (Conventional Arthroscopic Suturing Disc Repositioning) |
Who may qualify
- Ages
- 15 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years.
- Both sexes.
- Patients with TMJ internal derangement (disc displacement without reduction).
- Patients indicated for arthroscopic disc repositioning following failure of conservative management.
Key exclusion criteria (5 listed)
- Previous TMJ surgery on the affected joint.
- Rheumatoid arthritis, systemic inflammatory joint disease, or other TMJ pathology (tumor, fracture, infection)
- Severe degenerative joint disease (osteoarthritis grade V) or ankylosis.
- Patients are unable to comply with follow-up assessments or MRI evaluation.
- Patients with TMDS are secondary to malocclusion.
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 |
|---|---|---|
| Fast-Fix-Enhanced ArthroscopicDevice: The FasT-Fix system is a medical device designed for an "all-inside" arthroscopic meniscal repair. | Procedure or surgery | Fast-Fix-Enhanced Arthroscopic Disc Repositioning |
| (Conventional Arthroscopic Suturing Disc Repositioning)Arthroscopic TMJ discopexy using conventional suturing Minimally invasive surgical intervention | Procedure or surgery | Conventional Arthroscopic Suturing Disc Repositioning |
Primary outcome
Functional improvement assessed by Maximum Mouth Opening (MIO)
Time frame: Baseline (preoperative) to 6 months postoperatively (with assessments at 3 months and 6 months; primary endpoint at 6 months
MIO is measured as the maximal interincisal distance (in millimeters) using a ruler or digital caliper, with the primary endpoint being the change from baseline to 6 months postoperatively.
4 secondary outcomes
Clinical outcomes , Pain reduction assessed using the Visual Analogue Scale (VAS) • Improvement of joint symptoms, including clicking and tenderness.
Time frame: Baseline (preoperative), 3 months, and 6 months postoperatively
Joint Symptoms (Clicking and Tenderness)
Time frame: Baseline (preoperative), 3 months, and 6 months postoperatively
Surgical outcomes Total surgical time recorded
Time frame: Intraoperative (day of procedure only)
surgical outcomes Technical Feasibility
Time frame: Intraoperative (day of procedure only)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Fast-Fix-Enhanced Arthroscopic and (Conventional Arthroscopic Suturing Disc Repositioning) in people with Temporomandibular Joint Internal Derangement, 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 4 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: opening soon, as of the sponsor's last update on 6 Jan 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact wajmah Al Sayed, PHD (0509560055, wajmah.sayed@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional improvement assessed by Maximum Mouth Opening (MIO) (time frame: Baseline (preoperative) to 6 months postoperatively (with assessments at 3 months and 6 months; primary endpoint at 6 months). 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 6 Jan 2026.