Anterior Disc DisplacementNCT07076355
Ultrasound-Guided Botulinum Toxin A Injection for TMJ Disc Displacement With Reduction
A study testing Botulinum Toxin type a (Botox) in people with Anterior Disc Displacement, run by Tanta University at 1 site in Egypt.
Trial summary
This clinical trial was designed to evaluate the effectiveness of ultrasonography-guided botulinum toxin type A (BTX-A) injection into the lateral pterygoid muscle for the management of temporomandibular joint (TMJ) anterior disc displacement with reduction (ADDwR). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anterior Disc Displacement
- What is being tested?
- Botulinum Toxin type a (Botox)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 23 May 2024to 26 Dec 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with bilateral anterior disc displacement with reduction (ADDwR) using Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD).
- Patients aged 18 years or older.
- Patients who did not respond to previous conservative treatments.
Who cannot join
- Known allergy to any components of botulinum toxin type A (BTX-A).
- Presence of temporomandibular joint (TMJ) hypermobility.
- History of TMJ surgery.
- Presence of any significant pathology around the TMJ.
- Pregnant women.
- Individuals with systemic diseases that may affect the TMJ or the procedure.
- Patients with blood coagulopathy.
- Patients with unilateral ADDwR.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Dentistry, Tanta University
Tanta, Gharbia Governorate, 31527
About this study
Official title: Evaluation of the Ultrasonography-Guidance for Botulinum Toxin Type A Injection Into Lateral Pterygoid Muscle in Patients With TMJ Anterior Disc Displacement With Reduction
This clinical trial was designed to evaluate the effectiveness of ultrasonography-guided botulinum toxin type A (BTX-A) injection into the lateral pterygoid muscle for the management of temporomandibular joint (TMJ) anterior disc displacement with reduction (ADDwR). Ten patients diagnosed with ADDwR participated in the study. Each patient received an ultrasound-guided injection of 25 units of BTX-A into the lateral pterygoid muscle under local anesthesia. Clinical evaluations were performed preoperatively and at 2, 6, 12, and 24 weeks postoperatively. Outcome measures included pain levels assessed by the Numerical Rating Scale (NRS), TMJ sounds (clicking) detected using a stethoscope, disc position assessed by MRI, mandibular function parameters such as lateral excursion and maximum interincisal opening, and the Fonseca's questionnaire scores. The results demonstrated a significant reduction in pain and TMJ sounds, improvement in disc position, and enhanced mandibular function over a 6-month follow-up period. These findings suggest that ultrasonography-guided BTX-A injection into the lateral pterygoid muscle is a safe and effective treatment option for patients with TMJ ADDwR.
Read the detailed description
This study investigated the therapeutic potential of ultrasonography-guided botulinum toxin type A (BTX-A) injection into the lateral pterygoid muscle in patients diagnosed with temporomandibular joint (TMJ) anterior disc displacement with reduction (ADDwR). The intervention was performed under local anesthesia with patient monitoring. High-frequency ultrasonography was utilized to accurately identify the lateral pterygoid muscle and guide the injection to minimize risks to adjacent anatomical structures.
The study followed patients over a 6-month period to assess changes in TMJ-related pain, functional parameters, and disc position. Pain intensity was measured using the Numerical Pain Rating Scale (NPRS), joint sounds were assessed clinically and with a stethoscope, disc position was evaluated via MRI, and mandibular movements were assessed by measuring lateral excursion and maximum interincisal opening. Patient-reported outcomes were also evaluated using the Fonseca's questionnaire.
The findings demonstrated a significant reduction in TMJ pain and joint noises, as well as improved mandibular function and disc alignment during the follow-up period. No major complications were observed, supporting the safety and efficacy of ultrasound-guided BTX-A injections in managing ADDwR.
This research provides clinical evidence for a minimally invasive and precise technique to manage TMJ internal derangements and reduce the impact of hyperactive lateral pterygoid muscle activity.
- Conditions
- Anterior Disc Displacement
- Being tested
- Botulinum Toxin type a (Botox)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum Toxin type a (Botox)Drug
Also called BTX-A
A single dose of 25 units of botulinum toxin type A (BTX-A) was injected into the lateral pterygoid muscle using ultrasonography-guided technique. The injection was performed under local anesthesia with patient monitoring.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound-Guided Botulinum Toxin Type A Injection | Experimental | Patients in this arm received an ultrasound-guided injection of botulinum toxin type A (BTX-A) into the lateral pterygoid muscle to treat temporomandibular joint anterior disc displacement with reduction (ADDwR). The procedure was performed under local anesthesia with real-time ultrasonographic visualization to ensure accurate delivery and minimize complications. Receives: Drug: Botulinum Toxin type a (Botox) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Intensity on the Numerical Pain Rating Scale (NPRS)
The Numerical Pain Rating Scale (0-10) was used to assess changes in pain intensity from baseline to follow-up time frames, with higher scores indicating greater pain.
Measured: Baseline (preoperative), 2 weeks, 6 weeks, 12 weeks, and 24 weeks post-injection
Secondary outcomes (5)
Change in TMJ Clicking Sounds
Joint sounds were assessed using a stethoscope and scored as absent, heard only with a stethoscope, or heard unaided. We also quantified the intensity of the clicking sound using a custom made digital stethoscope to measure the sound in decibel units.
Measured: Baseline and at 2, 6, 12, and 24 weeks.
Change in Maximum Interincisal Opening (MIO)
Maximum interincisal opening (measured in millimeters) were recorded at each follow-up.
Measured: Baseline and at 2, 6, 12, and 24 weeks.
Change in Lateral Excursion of the Mandible
Lateral excursion (measured in millimeters) was recorded on both sides.
Measured: Baseline and at 2, 6, 12, and 24 weeks.
Change in Disc Position on MRI
Disc position was assessed using MRI and recorded as an angular measurement (degrees) relative to the condyle.
Measured: baseline (preintervention) and 12 weeks postintervention.
Change in Fonseca's Questionnaire Score
Fonseca's questionnaire was used to evaluate TMJ dysfunction severity on a scale from 0 to 100.
Measured: baseline (preintervention) and 24 weeks postintervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study start23 May 2024
- Primary completion26 Dec 2024
- Study completion26 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Disc DisplacementStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rosie Abdulqahar Othman, Tanta University
- Investigators
- Rosie A Othman, Principal investigator, Tanta UniversityIbrahim M Nowair, Principal investigator, Faculty of Dentistry, Tanta University, EgyptAhmed G Abushahba, Principal investigator, Faculty of Dentistry, Tanta University, EgyptMohamed S Abdelghany Elbrol, Principal investigator, Faculty of Medicine, Tanta University, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07076355
- Sponsor's protocol ID
- OS-3-24-2126
- Status last verified
- Jul 2025
- First submitted
- 14 Jul 2025
- Last updated
- 12 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Ultrasonography-Guidance for Botulinum Toxin Type A Injection Into Lateral Pterygoid Muscle in Patients With TMJ Anterior Disc Displacement With Reduction
- ClinicalTrials.gov ID
- NCT07076355
- Acronym / sponsor ID
- OS-3-24-2126
- Conditions
- Anterior Disc Displacement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 23 May 2024 (actual)
- Primary completion
- 26 Dec 2024 (actual)
- Study completion
- 26 Dec 2024 (actual)
- First posted
- 22 Jul 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.
This clinical trial was designed to evaluate the effectiveness of ultrasonography-guided botulinum toxin type A (BTX-A) injection into the lateral pterygoid muscle for the management of temporomandibular joint (TMJ) anterior disc displacement with reduction (ADDwR). Ten patients diagnosed with ADDwR participated in the study. Each patient received an ultrasound-guided injection of 25 units of BTX-A into the lateral pterygoid muscle under local anesthesia. Clinical evaluations were performed preoperatively and at 2, 6, 12, and 24 weeks postoperatively. Outcome measures included pain levels assessed by the Numerical Rating Scale (NRS), TMJ sounds (clicking) detected using a stethoscope, disc position assessed by MRI, mandibular function parameters such as lateral excursion and maximum interincisal opening, and the Fonseca's questionnaire scores. The results demonstrated a significant reduction in pain and TMJ sounds, improvement in disc position, and enhanced mandibular function over a 6-month follow-up period. These findings suggest that ultrasonography-guided BTX-A injection into the lateral pterygoid muscle is a safe and effective treatment option for patients with TMJ ADDwR.
Detailed description
This study investigated the therapeutic potential of ultrasonography-guided botulinum toxin type A (BTX-A) injection into the lateral pterygoid muscle in patients diagnosed with temporomandibular joint (TMJ) anterior disc displacement with reduction (ADDwR). The intervention was performed under local anesthesia with patient monitoring. High-frequency ultrasonography was utilized to accurately identify the lateral pterygoid muscle and guide the injection to minimize risks to adjacent anatomical structures.
The study followed patients over a 6-month period to assess changes in TMJ-related pain, functional parameters, and disc position. Pain intensity was measured using the Numerical Pain Rating Scale (NPRS), joint sounds were assessed clinically and with a stethoscope, disc position was evaluated via MRI, and mandibular movements were assessed by measuring lateral excursion and maximum interincisal opening. Patient-reported outcomes were also evaluated using the Fonseca's questionnaire.
The findings demonstrated a significant reduction in TMJ pain and joint noises, as well as improved mandibular function and disc alignment during the follow-up period. No major complications were observed, supporting the safety and efficacy of ultrasound-guided BTX-A injections in managing ADDwR.
This research provides clinical evidence for a minimally invasive and precise technique to manage TMJ internal derangements and reduce the impact of hyperactive lateral pterygoid muscle activity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ultrasound-Guided Botulinum Toxin Type A Injection | Experimental | Drug: Botulinum Toxin type a (Botox)Patients in this arm received an ultrasound-guided injection of botulinum toxin type A (BTX-A) into the lateral pterygoid muscle to treat temporomandibular joint anterior disc displacement with reduction (ADDwR). The procedure was performed under local anesthesia with real-time ultrasonographic visualization to ensure accurate delivery and minimize complications. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients diagnosed with bilateral anterior disc displacement with reduction (ADDwR) using Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD).
- Patients aged 18 years or older.
- Patients who did not respond to previous conservative treatments.
Key exclusion criteria (8 listed)
- Known allergy to any components of botulinum toxin type A (BTX-A).
- Presence of temporomandibular joint (TMJ) hypermobility.
- History of TMJ surgery.
- Presence of any significant pathology around the TMJ.
- Pregnant women.
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 (Botox)Also: BTX-AA single dose of 25 units of botulinum toxin type A (BTX-A) was injected into the lateral pterygoid muscle using ultrasonography-guided technique. The injection was performed under local anesthesia with patient monitoring. | Drug | Ultrasound-Guided Botulinum Toxin Type A Injection |
Primary outcome
Change in Pain Intensity on the Numerical Pain Rating Scale (NPRS)
Time frame: Baseline (preoperative), 2 weeks, 6 weeks, 12 weeks, and 24 weeks post-injection
The Numerical Pain Rating Scale (0-10) was used to assess changes in pain intensity from baseline to follow-up time frames, with higher scores indicating greater pain.
5 secondary outcomes
Change in TMJ Clicking Sounds
Time frame: Baseline and at 2, 6, 12, and 24 weeks.
Change in Maximum Interincisal Opening (MIO)
Time frame: Baseline and at 2, 6, 12, and 24 weeks.
Change in Lateral Excursion of the Mandible
Time frame: Baseline and at 2, 6, 12, and 24 weeks.
Change in Disc Position on MRI
Time frame: baseline (preintervention) and 12 weeks postintervention.
Change in Fonseca's Questionnaire Score
Time frame: baseline (preintervention) and 24 weeks postintervention.
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 12 Aug 2025.
- Individual participant dataSharing planned: No
Related trials for Anterior Disc Displacement
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Liquid Phase Concentrated Growth Factor Versus Conventional Arthrocentesis in Temporomandibular Disc Displacement
Temporomandibular Disorders (TMD), Internal Derangement of the Tempromandibular Joint
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Comparison of Conventional,3D Printed and Novel Hybrid Stabilization Splints in the Management of Temporomandibular Joint Disorders
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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.
Rosie A Othman principal investigator
Tanta University
Ibrahim M Nowair principal investigator
Faculty of Dentistry, Tanta University, Egypt
Ahmed G Abushahba principal investigator
Faculty of Dentistry, Tanta University, Egypt
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 (Botox) in people with Anterior Disc Displacement, run by Tanta 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 8 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 12 Aug 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?
Change in Pain Intensity on the Numerical Pain Rating Scale (NPRS) (time frame: Baseline (preoperative), 2 weeks, 6 weeks, 12 weeks, and 24 weeks post-injection). 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 12 Aug 2025.