Temporomandibular Joint Disc DisplacementNCT06850142
A Comparative Study Between TMJ Discopexy to External Ear Cartilage Versus to Temporal Fascia
A study testing Discopexy to external ear cartilage and Discopexy to temporal fascia in people with Temporomandibular Joint Disc Displacement and Temporomandibular Joint Disc Displacement, Without Reduction, run by Fayoum University at 1 site in Egypt.
Trial summary
Discopexy is a surgical procedure aimed at stabilizing the articular disc within the temporomandibular joint (TMJ) in patients experiencing TMJ disorders (TMD). The TMJ is a complex joint responsible for jaw movement, and its proper function relies on the alignment and stability of the articular disc, a… Read more about this study
- Who is it for?
- Ages 35 to 60 years
- Conditions the study is for
- Temporomandibular Joint Disc Displacement, Temporomandibular Joint Disc Displacement, Without Reduction
- What is being tested?
- Discopexy to external ear cartilage and Discopexy to temporal fascia
- 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
- 5 Jan 2022to 22 Jan 2025
- 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 35 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with primary TMD with complete anterior disc displacement without reduction with no or minimal osteoarthritic changes
Who cannot join
- osteoarthritis
Trial locations and contacts
1 site in 1 country.
About this study
Discopexy is a surgical procedure aimed at stabilizing the articular disc within the temporomandibular joint (TMJ) in patients experiencing TMJ disorders (TMD). The TMJ is a complex joint responsible for jaw movement, and its proper function relies on the alignment and stability of the articular disc, a fibrocartilaginous structure that cushions the joint. In cases of disc displacement or dysfunction, patients may experience pain, clicking, limited jaw movement, and other symptoms.
Read the detailed description
Discopexy involves repositioning and securing the displaced disc to its anatomical position, often using sutures or anchors, to restore normal joint mechanics and alleviate symptoms. This procedure is typically considered when conservative treatments, such as physical therapy or splints, have failed to provide relief. Discopexy aims to improve joint function, reduce pain, and prevent further degenerative changes in the TMJ. The aim of the present study is to compare between new surgical techniques of discopexy of TMJ disc either to external ear cartilage or to temporal fascia.
- Conditions
- Temporomandibular Joint Disc Displacement, Temporomandibular Joint Disc Displacement, Without Reduction
- Being tested
- Discopexy to external ear cartilage, Discopexy to temporal fascia
- Keywords
- External ear cartilage, Anterior disc displacement without reduction., Temporal fascia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Discopexy to external ear cartilageProcedure or surgery
stabilizing the articular disc within the temporomandibular joint (TMJ) in patients experiencing TMJ disorders (TMD) to external ear cartilage
Discopexy to temporal fasciaProcedure or surgery
stabilizing the articular disc within the temporomandibular joint (TMJ) in patients experiencing TMJ disorders (TMD) to temporal fascia
| Study group | Role | What they receive |
|---|---|---|
| discopexy of Temporo-mandibular joint (TMJ) disc to external ear cart | Experimental | 30 patients underwent discopexy of Temporo-mandibular joint (TMJ) disc to external ear cartilage Receives: Procedure: Discopexy to external ear cartilage |
| discopexy of TMJ disc to temporal fascia. | Active comparator | Patients underwent discopexy of TMJ disc to temporal fascia. Receives: Procedure: Discopexy to temporal fascia |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Visual Analog Scale (VAS)
The Visual Analog Scale (VAS) It consists of a straight line, typically 10 centimeters (100 mm) in length, with one end labeled "No Pain" and the other end labeled "Worst Pain Imaginable."
Measured: baseline, 1 month, 3 months, 6 months
Secondary outcomes (2)
Disc position
assess the position of the articular disc in the TMJ either Normal, anterior displacement (with or without reduction), posterior displacement, or lateral displacement.
Measured: baseline, 1 month, 3 months, 6 months
Maximum Mouth opening
used to assess the functional capacity of the temporomandibular joint (TMJ) and the surrounding musculoskeletal structures.
Measured: baseline, 1 month, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2025
- Study start5 Jan 2022
- Primary completion19 Jul 2024
- Study completion22 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Temporomandibular Joint Disc DisplacementStudies of the same condition, open and under way.
- 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
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fayoum University
- Sponsor type
- University, hospital or other
- Collaborators
- Sohag University
- Responsible party
- Principal investigator, Alshaimaa Ahmed shabaan, Fayoum University
- Investigators
- Alshaimaa shabaan, PhD, Principal investigator, Fayoum University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06850142
- Sponsor's protocol ID
- TMJ discopexy
- Status last verified
- Feb 2025
- First submitted
- 22 Feb 2025
- Last updated
- 27 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gonzalez LV, Lopez JP, Orjuela MP, de la Sen O, Diaz-Baez D, Martin-Granizo R. Could temporomandibular joint arthroscopic discopexy with resorbable pins or disc mobilisation influence mandibular condyle marrow? Br J Oral Maxillofac Surg. 2025 Jan;63(1):39-46. doi: 10.1016/j.bjoms.2024.10.226. Epub 2024 Oct 10.
PubMed 39592295Jerez-Frederick D, Albers D, Fuenzalida C, Laissle G, Avila-Oliver C. Is the Complexity of Arthroscopic Temporomandibular Joint Surgery Associated With Short-Term Complication Rates? J Oral Maxillofac Surg. 2025 Mar;83(3):270-278. doi: 10.1016/j.joms.2024.11.008. Epub 2024 Nov 20.
PubMed 39645229Renapurkar SK. Discectomy Versus Disc Preservation for Internal Derangement of the Temporomandibular Joint. Oral Maxillofac Surg Clin North Am. 2018 Aug;30(3):329-333. doi: 10.1016/j.coms.2018.05.002. Epub 2018 Jun 7.
PubMed 29885876
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study Between TMJ Discopexy to External Ear Cartilage Versus to Temporal Fascia
- ClinicalTrials.gov ID
- NCT06850142
- Acronym / sponsor ID
- TMJ discopexy
- Conditions
- Temporomandibular Joint Disc Displacement, Temporomandibular Joint Disc Displacement, Without Reduction
- Keywords
- External ear cartilage, Anterior disc displacement without reduction., Temporal fascia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Fayoum UniversityUniversity, hospital or other
- Collaborators
- Sohag University
- Study start
- 5 Jan 2022 (actual)
- Primary completion
- 19 Jul 2024 (actual)
- Study completion
- 22 Jan 2025 (actual)
- First posted
- 27 Feb 2025 (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.
Discopexy is a surgical procedure aimed at stabilizing the articular disc within the temporomandibular joint (TMJ) in patients experiencing TMJ disorders (TMD). The TMJ is a complex joint responsible for jaw movement, and its proper function relies on the alignment and stability of the articular disc, a fibrocartilaginous structure that cushions the joint. In cases of disc displacement or dysfunction, patients may experience pain, clicking, limited jaw movement, and other symptoms.
Detailed description
Discopexy involves repositioning and securing the displaced disc to its anatomical position, often using sutures or anchors, to restore normal joint mechanics and alleviate symptoms. This procedure is typically considered when conservative treatments, such as physical therapy or splints, have failed to provide relief. Discopexy aims to improve joint function, reduce pain, and prevent further degenerative changes in the TMJ. The aim of the present study is to compare between new surgical techniques of discopexy of TMJ disc either to external ear cartilage or to temporal fascia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| discopexy of Temporo-mandibular joint (TMJ) disc to external ear cart | Experimental | Procedure: Discopexy to external ear cartilage30 patients underwent discopexy of Temporo-mandibular joint (TMJ) disc to external ear cartilage |
| discopexy of TMJ disc to temporal fascia. | Active comparator | Procedure: Discopexy to temporal fasciaPatients underwent discopexy of TMJ disc to temporal fascia. |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients with primary TMD with complete anterior disc displacement without reduction with no or minimal osteoarthritic changes
Key exclusion criteria (1 listed)
- osteoarthritis
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 |
|---|---|---|
| Discopexy to external ear cartilagestabilizing the articular disc within the temporomandibular joint (TMJ) in patients experiencing TMJ disorders (TMD) to external ear cartilage | Procedure or surgery | discopexy of Temporo-mandibular joint (TMJ) disc to external ear cart |
| Discopexy to temporal fasciastabilizing the articular disc within the temporomandibular joint (TMJ) in patients experiencing TMJ disorders (TMD) to temporal fascia | Procedure or surgery | discopexy of TMJ disc to temporal fascia. |
Primary outcome
The Visual Analog Scale (VAS)
Time frame: baseline, 1 month, 3 months, 6 months
The Visual Analog Scale (VAS) It consists of a straight line, typically 10 centimeters (100 mm) in length, with one end labeled "No Pain" and the other end labeled "Worst Pain Imaginable."
2 secondary outcomes
Disc position
Time frame: baseline, 1 month, 3 months, 6 months
Maximum Mouth opening
Time frame: baseline, 1 month, 3 months, 6 months
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 27 Feb 2025.
- Background: PubMed 39592295Gonzalez LV, Lopez JP, Orjuela MP, de la Sen O, Diaz-Baez D, Martin-Granizo R. Could temporomandibular joint arthroscopic discopexy with resorbable pins or disc mobilisation influence mandibular condyle marrow? Br J Oral Maxillofac Surg. 2025 Jan;63(1):39-46. doi: 10.1016/j.bjoms.2024.10.226. Epub 2024 Oct 10.
- Results publication: PubMed 39645229Jerez-Frederick D, Albers D, Fuenzalida C, Laissle G, Avila-Oliver C. Is the Complexity of Arthroscopic Temporomandibular Joint Surgery Associated With Short-Term Complication Rates? J Oral Maxillofac Surg. 2025 Mar;83(3):270-278. doi: 10.1016/j.joms.2024.11.008. Epub 2024 Nov 20.
- Results publication: PubMed 29885876Renapurkar SK. Discectomy Versus Disc Preservation for Internal Derangement of the Temporomandibular Joint. Oral Maxillofac Surg Clin North Am. 2018 Aug;30(3):329-333. doi: 10.1016/j.coms.2018.05.002. Epub 2018 Jun 7.
- Individual participant dataSharing planned: No
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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.
Alshaimaa shabaan, PhD principal investigator
Fayoum University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Discopexy to external ear cartilage and Discopexy to temporal fascia in people with Temporomandibular Joint Disc Displacement and Temporomandibular Joint Disc Displacement, Without Reduction, run by Fayoum 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 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 27 Feb 2025. 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?
The Visual Analog Scale (VAS) (time frame: baseline, 1 month, 3 months, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06850142, which also lists 3 linked publications.
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 27 Feb 2025; AzTrials last refreshed its copy on 29 Oct 2026.