Anterior Disc DisplacementNCT06633445
Injecting Lateral Pterygoid Muscle by Botulinum Toxin Type A With 2 Different Methods : 3D Guided Appliance and Electromyography (EMG) .
A study testing botulinum toxin type A injection in lateral pterygoid muscle and botox injection in lateral pterygoid muscle in people with Anterior Disc Displacement, run by Mahmoud Akram Khodir at 1 site in Egypt.
Trial summary
The goal of this study is to evaluate intra-oral botulinum toxin type A injection into lateral pterygoid muscle using a surgical guide synthesized by virtual planning based on CT with soft tissue window. To evaluate improvement of maximum interincisal opening (MIO) before and after injection. Read more about this study
- Who is it for?
- Ages 20 to 45 years
- Conditions the study is for
- Anterior Disc Displacement
- What is being tested?
- botulinum toxin type A injection in lateral pterygoid muscle and botox injection in lateral pterygoid muscle
- 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
- 1 siteEgypt
- Study dates
- 1 Nov 2023to 1 Sep 2024
- 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 20 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients of both sexes that are diagnosed with ADDWR according to DC/TMD.
- Their age range between 20 and 45 years.
- Angle class I maxilla-mandibular relation.
Who cannot join
- Patients with degenerative joint disease, musculoskeletal, neuromuscular disorders, cardiovascular, bleeding disorders, breathing difficulties, neurological disorders.
- Pregnancy and lactating women.
- History of surgical TMJ intervention.
- Botox hypersensitivity
- History of tumors or maxillofacial trauma.
- Posteriorly edentulous saddles or anterior open bite.
- Patient contraindicated to MRI examination
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of 3D Guided Botulinum Toxin Type A Injection in Lateral Pterygoid Muscle for Management of Patients With Anterior Disc Displacement With Reduction ( a Randomized Controlled Clinical Trial )
The goal of this study is to evaluate intra-oral botulinum toxin type A injection into lateral pterygoid muscle using a surgical guide synthesized by virtual planning based on CT with soft tissue window.
- To evaluate improvement of maximum interincisal opening (MIO) before and after injection.
- To assess change in disc position before and after injection.
- To evaluate recovery of symptoms as clicking, tenderness of TMJ and tenderness of lateral pterygoid muscle after injection.
Read more
Researchers will compare intra-oral botulinum toxin type A injection using a surgical guide synthesized by virtual planning based on CT with soft tissue window to conventional EMG guided botulinum toxin injection into lateral pterygoid muscle in patient with anterior disc displacement with reduction.
Participants will be injected with botulinum toxin type A by intraoral approach.
- Conditions
- Anterior Disc Displacement
- Being tested
- botulinum toxin type A injection in lateral pterygoid muscle, botox injection in lateral pterygoid muscle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
botulinum toxin type A injection in lateral pterygoid muscleProcedure or surgery
- Needle insertion guide will be placed on upper teeth.
- Needle will be inserted from needle insertion sleeve and 25-30 units of botulinum toxin type A will be injected.
- Aspiration will be done before injection, and then, the patient will be asked to manipulate the mandible to activate the lateral pterygoid muscle.
botox injection in lateral pterygoid muscleProcedure or surgery
- A 27- gauge needle electrode will be inserted lateral to the maxillary tuberosity, just above the maxillary molars to inject 25-30 units of botulinum toxin type A under electromyographic guidance.
- Aspiration will be done before injection, and then the patient will be asked to manipulate the mandible to activate the lateral pterygoid muscle.
- The intramuscular injection will be confirmed when the electromyographic device produces a distinct loud sound.
| Study group | Role | What they receive |
|---|---|---|
| 3D guided botulinum toxin injection arm | Experimental | Not described Receives: Procedure: botulinum toxin type A injection in lateral pterygoid muscle |
| Electromyography botulinum toxin injection arm | Active comparator | Not described Receives: Procedure: botox injection in lateral pterygoid muscle |
What is being measured
The primary outcome is the main question the study is designed to answer.
• Maximum interincisal opening in millimeters.
measured in millimeters from incisal edge of uppercentrals to incisal edge of lower incisors by disposable rulers.
Measured: 6 months
clicking
Any noticeable sound detected temporomandibular joint during opening and closing
Measured: 6 months
temporomandiular joint tenderness
using visual analogue scale to measure pain intensity diagrammed in a line with two ends representing 0 ( no pain) and 10 ( the worst pain) after lateral and auriculotemporal palpation of temporomandibular joint
Measured: 6 months
lateral pterygoid muscle tenderness
using visual analogue scale to measure pain intensity diagrammed in a line with two ends representing 0 ( no pain) and 10 ( the worst pain) after intraoral palpation of lateral pterygoid muscle behind tuberosity
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2024
- Study start1 Nov 2023
- Primary completion1 Jun 2024
- Study completion1 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anterior 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
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahmoud Akram Khodir
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mahmoud Akram Khodir, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06633445
- Sponsor's protocol ID
- 3D guided Botox injection
- Status last verified
- Jan 2025
- First submitted
- 1 Oct 2024
- Last updated
- 27 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Raafa N, Melek L, Zoheir H, Mansour E, Sakr A. A novel fully guided technique for botulinum toxin injection in lateral pterygoid muscle using muscle segmentation for TMJ disc displacement with reduction: a randomized controlled trial. BMC Oral Health. 2025 Jun 21;25(1):957. doi: 10.1186/s12903-025-06372-w.
PubMed 40544291
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of 3D Guided Botulinum Toxin Type A Injection in Lateral Pterygoid Muscle for Management of Patients With Anterior Disc Displacement With Reduction ( a Randomized Controlled Clinical Trial )
- ClinicalTrials.gov ID
- NCT06633445
- Acronym / sponsor ID
- 3D guided Botox injection
- Conditions
- Anterior Disc Displacement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Mahmoud Akram KhodirUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 9 Oct 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 goal of this study is to evaluate intra-oral botulinum toxin type A injection into lateral pterygoid muscle using a surgical guide synthesized by virtual planning based on CT with soft tissue window.
- To evaluate improvement of maximum interincisal opening (MIO) before and after injection.
- To assess change in disc position before and after injection.
- To evaluate recovery of symptoms as clicking, tenderness of TMJ and tenderness of lateral pterygoid muscle after injection.
Researchers will compare intra-oral botulinum toxin type A injection using a surgical guide synthesized by virtual planning based on CT with soft tissue window to conventional EMG guided botulinum toxin injection into lateral pterygoid muscle in patient with anterior disc displacement with reduction.
Participants will be injected with botulinum toxin type A by intraoral approach.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3D guided botulinum toxin injection arm | Experimental | Procedure: botulinum toxin type A injection in lateral pterygoid muscle |
| Electromyography botulinum toxin injection arm | Active comparator | Procedure: botox injection in lateral pterygoid muscle |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients of both sexes that are diagnosed with ADDWR according to DC/TMD.
- Their age range between 20 and 45 years.
- Angle class I maxilla-mandibular relation.
Key exclusion criteria (7 listed)
- Patients with degenerative joint disease, musculoskeletal, neuromuscular disorders, cardiovascular, bleeding disorders, breathing difficulties, neurological disorders.
- Pregnancy and lactating women.
- History of surgical TMJ intervention.
- Botox hypersensitivity
- History of tumors or maxillofacial trauma.
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 |
|---|---|---|
| botulinum toxin type A injection in lateral pterygoid muscle* Needle insertion guide will be placed on upper teeth. * Needle will be inserted from needle insertion sleeve and 25-30 units of botulinum toxin type A will be injected. * Aspiration will be done before injection, and then, the patient will be asked to manipulate the mandible to activate the lateral pterygoid muscle. | Procedure or surgery | 3D guided botulinum toxin injection arm |
| botox injection in lateral pterygoid muscle* A 27- gauge needle electrode will be inserted lateral to the maxillary tuberosity, just above the maxillary molars to inject 25-30 units of botulinum toxin type A under electromyographic guidance. * Aspiration will be done before injection, and then the patient will be asked to manipulate the mandible to activate the lateral pterygoid muscle. * The intramuscular injection will be confirmed when the electromyographic device produces a distinct loud sound. | Procedure or surgery | Electromyography botulinum toxin injection arm |
Primary outcome
• Maximum interincisal opening in millimeters.
Time frame: 6 months
measured in millimeters from incisal edge of uppercentrals to incisal edge of lower incisors by disposable rulers.
clicking
Time frame: 6 months
Any noticeable sound detected temporomandibular joint during opening and closing
temporomandiular joint tenderness
Time frame: 6 months
using visual analogue scale to measure pain intensity diagrammed in a line with two ends representing 0 ( no pain) and 10 ( the worst pain) after lateral and auriculotemporal palpation of temporomandibular joint
lateral pterygoid muscle tenderness
Time frame: 6 months
using visual analogue scale to measure pain intensity diagrammed in a line with two ends representing 0 ( no pain) and 10 ( the worst pain) after intraoral palpation of lateral pterygoid muscle behind tuberosity
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 Jan 2025.
- Derived from this study: PubMed 40544291Raafa N, Melek L, Zoheir H, Mansour E, Sakr A. A novel fully guided technique for botulinum toxin injection in lateral pterygoid muscle using muscle segmentation for TMJ disc displacement with reduction: a randomized controlled trial. BMC Oral Health. 2025 Jun 21;25(1):957. doi: 10.1186/s12903-025-06372-w.
- Individual participant dataSharing planned: Undecided
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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.
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 botulinum toxin type A injection in lateral pterygoid muscle and botox injection in lateral pterygoid muscle in people with Anterior Disc Displacement, run by Mahmoud Akram Khodir 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 27 Jan 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?
• Maximum interincisal opening in millimeters. (time frame: 6 months). The study lists 4 primary outcomes in all. 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 NCT06633445, which also lists 1 linked publication.
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 Jan 2025.