Temporomandibular DisorderPhase 2NCT07847541
Clinical Evaluation of Botulinum Toxin a in the Management of Temporomandibular Myofascial Pain
A Phase 2 study testing Botulinum Toxin Type A (BoNT-A) in people with Temporomandibular Disorder, run by Riphah International University at 1 site in Pakistan.
Trial summary
This study is a randomized, double-blind, placebo-controlled clinical trial designed to evaluate the effectiveness of botulinum toxin type A (BoNT-A) in patients with temporomandibular myofascial pain who have not improved after at least 3 months of conservative treatment. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Temporomandibular Disorder
- What is being tested?
- Botulinum Toxin Type A (BoNT-A)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 118 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Aug 2026to 15 Dec 2026
- Phase
- Phase 2
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- History of TMD, no relief with conservative therapy after at least three months.
- Clinical diagnosis of bilateral arthrogenous disorder and myalgia.
- Moreover, TMD can be confirmed by diagnosis through MRI and CT examinations
- Pregnancy or lactation.
- Previous mandible or significant facial trauma.
- History of prior TMD treatment or cosmetic treatments of the face with BoNT/A.
- Any contraindication to BoNT/A as outlined in the XEOMIN package insert.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Islamic International Dental Hospital
Islamabad, 44000
Uzair Luqman, FCPS, +923215080354, uzair.luqman@riphah.edu.pk
About this study
This study is a randomized, double-blind, placebo-controlled clinical trial designed to evaluate the effectiveness of botulinum toxin type A (BoNT-A) in patients with temporomandibular myofascial pain who have not improved after at least 3 months of conservative treatment.
Eligible patients aged 18-60 years will be randomly assigned to one of two groups:
Read more
- Intervention group: Intramuscular injection of 100 U BoNT-A into the bilateral masseter and temporalis muscles.
- Control group: Intramuscular injection of 0.9% normal saline (placebo) using the same technique.
The primary outcomes will be:
- Pain intensity, measured using a 0-10 pain scale (VAS/NRS).
- Maximum mouth opening (maximal interincisal distance), measured in millimetres.
Assessments will be performed before treatment (baseline) and at 1 week, 1 month, and 3 months after injection. The study will also monitor adverse events associated with the injections.
The aim is to determine whether BoNT-A provides greater pain relief and improved mouth opening compared with placebo in patients with temporomandibular myofascial pain. The findings may help support the use of BoNT-A as a treatment option for patients who do not respond to conventional therapy and provide valuable evidence for clinical practice in Pakista
Read the detailed description
Temporomandibular disorders (TMDs) are a group of musculoskeletal and joint issues that affect the temporomandibular joint (TMJ), masticatory muscles, and associated structures. Common patient presentations that can significantly affect quality of life include pain, joint sounds, limited mouth opening, headaches, earaches, and functional impairment (1,2). The multiple causes of TMD, which include parafunctional habits like bruxism, internal derangements, trauma, and myofascial dysfunction, make diagnosis and therapy challenging (3,4).
Physical therapy, occlusal splints, muscle relaxants, and nonsteroidal anti-inflammatory drugs (NSAIDs) remain the primary line of conservative treatment (4). However, some patients with myofascial pain do not react well to conventional therapeutic methods, necessitating other approaches (5). The neurotoxin botulinum toxin type A (BoNT-A) blocks the release of acetylcholine at the neuromuscular junction, resulting in muscle relaxation and temporary chemodenervation (6). Numerous clinical studies have demonstrated that BoNT-A improves jaw function, reduces the intensity of discomfort, and increases maximal interincisal distance in individuals with myofascial TMD (5-7). Even though there is noticeable pain relief, other trials show differing degrees of improvement in mouth opening, therefore the evidence is still inconclusive (6,7).
Given these disagreements, more randomized controlled trials (RCTs) are required to establish consistent treatment recommendations regarding dosage, injection sites, and follow-up schedules. The lack of local data from Pakistan about the use of BoNT-A in TMD therapy emphasizes the need for population-specific evidence.
Objectives:
To evaluate the effectiveness of botulinum toxin type A (BoNT-A) in patients with temporomandibular myofascial pain, by assessing changes in pain intensity and maximal interincisal distance compared with placebo.
- Conditions
- Temporomandibular Disorder
- Being tested
- Botulinum Toxin Type A (BoNT-A), 0.9% Normal Saline (Placebo)
- Keywords
- Temporomandibular Myofascial Pain
- 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.
Botulinum Toxin Type A (BoNT-A)Drug
Participants will receive a total dose of 100 units of Botulinum Toxin Type A (BoNT-A) administered by intramuscular injection into the bilateral masseter and temporalis muscles (25 U per side in each muscle). The injections will be performed using a 31G × 12 mm needle. Participants will be followed at 1 week, 1 month, and 3 months to assess pain intensity and maximal interincisal mouth opening.
0.9% Normal Saline (Placebo)Drug
Participants will receive 0.9% normal saline by intramuscular injection into the bilateral masseter and temporalis muscles using the same injection technique, volume, and follow-up schedule as the experimental group. The placebo is used to maintain blinding and serve as the comparator.
| Study group | Role | What they receive |
|---|---|---|
| Botulinum Toxin Type A (BoNT-A) | Experimental | Not described Receives: Drug: Botulinum Toxin Type A (BoNT-A) |
| Placebo (0.9% Normal Saline) | Placebo comparator | Not described Receives: Drug: 0.9% Normal Saline (Placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity Numerical Rating Scale
Changes in pain intensity can be measured using various scales, such as the 11-point Pain Intensity Numerical Rating Scale (PI-NRS), where 0=no pain and 10=worst possible pain. The PI-NRS is commonly used to assess pain intensity in chronic pain management. However, interpreting the clinical importance of changes from baseline on this scale can be challenging. Studies have estimated a clinically important difference on the PI-NRS by relating it to global assessments of change in multiple studies of chronic pain.
Measured: 1 week, 1 month, and 3 months after injection.
Change in maximal interincisal mouth opening (MIO)
The maximum interincisal distance (MID) is a crucial measurement for assessing the function of the temporomandibular joint (TMJ) and the masticatory muscles. It is measured by the distance between the upper and lower incisors when the mouth is fully opened. This measurement is particularly important in evaluating TMJ disorders and can indicate the health of the jaw and its associated muscles.
Measured: 1 week, 1 month, and 3 months after injection.
Secondary outcomes (2)
Incidence of adverse events
Incidence of adverse events
Measured: hroughout the 3-month follow-up period.
Pain during mandibular movements
Pain during mandibular movements
Measured: 1 week, 1 month, and 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study start15 Aug 2026
- Primary completion15 Dec 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular DisorderStudies of the same condition, open and under way.
- More trials run by Riphah International 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 118 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Uzair Luqman, FCPS, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07847541
- Sponsor's protocol ID
- IIDC/IRC/2025/11/005
- Status last verified
- Sep 2026
- First submitted
- 4 Aug 2026
- Last updated
- 29 Sep 2026
- 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 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Botulinum Toxin a in the Management of Temporomandibular Myofascial Pain
- ClinicalTrials.gov ID
- NCT07847541
- Acronym / sponsor ID
- IIDC/IRC/2025/11/005
- Conditions
- Temporomandibular Disorder
- Keywords
- Temporomandibular Myofascial Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 118 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Aug 2026 (actual)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 29 Sep 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 study is a randomized, double-blind, placebo-controlled clinical trial designed to evaluate the effectiveness of botulinum toxin type A (BoNT-A) in patients with temporomandibular myofascial pain who have not improved after at least 3 months of conservative treatment.
Eligible patients aged 18-60 years will be randomly assigned to one of two groups:
- Intervention group: Intramuscular injection of 100 U BoNT-A into the bilateral masseter and temporalis muscles.
- Control group: Intramuscular injection of 0.9% normal saline (placebo) using the same technique.
The primary outcomes will be:
- Pain intensity, measured using a 0-10 pain scale (VAS/NRS).
- Maximum mouth opening (maximal interincisal distance), measured in millimetres.
Assessments will be performed before treatment (baseline) and at 1 week, 1 month, and 3 months after injection. The study will also monitor adverse events associated with the injections.
The aim is to determine whether BoNT-A provides greater pain relief and improved mouth opening compared with placebo in patients with temporomandibular myofascial pain. The findings may help support the use of BoNT-A as a treatment option for patients who do not respond to conventional therapy and provide valuable evidence for clinical practice in Pakista
Detailed description
Temporomandibular disorders (TMDs) are a group of musculoskeletal and joint issues that affect the temporomandibular joint (TMJ), masticatory muscles, and associated structures. Common patient presentations that can significantly affect quality of life include pain, joint sounds, limited mouth opening, headaches, earaches, and functional impairment (1,2). The multiple causes of TMD, which include parafunctional habits like bruxism, internal derangements, trauma, and myofascial dysfunction, make diagnosis and therapy challenging (3,4).
Physical therapy, occlusal splints, muscle relaxants, and nonsteroidal anti-inflammatory drugs (NSAIDs) remain the primary line of conservative treatment (4). However, some patients with myofascial pain do not react well to conventional therapeutic methods, necessitating other approaches (5). The neurotoxin botulinum toxin type A (BoNT-A) blocks the release of acetylcholine at the neuromuscular junction, resulting in muscle relaxation and temporary chemodenervation (6). Numerous clinical studies have demonstrated that BoNT-A improves jaw function, reduces the intensity of discomfort, and increases maximal interincisal distance in individuals with myofascial TMD (5-7). Even though there is noticeable pain relief, other trials show differing degrees of improvement in mouth opening, therefore the evidence is still inconclusive (6,7).
Given these disagreements, more randomized controlled trials (RCTs) are required to establish consistent treatment recommendations regarding dosage, injection sites, and follow-up schedules. The lack of local data from Pakistan about the use of BoNT-A in TMD therapy emphasizes the need for population-specific evidence.
Objectives:
To evaluate the effectiveness of botulinum toxin type A (BoNT-A) in patients with temporomandibular myofascial pain, by assessing changes in pain intensity and maximal interincisal distance compared with placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Botulinum Toxin Type A (BoNT-A) | Experimental | Drug: Botulinum Toxin Type A (BoNT-A) |
| Placebo (0.9% Normal Saline) | Placebo comparator | Drug: 0.9% Normal Saline (Placebo) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- History of TMD, no relief with conservative therapy after at least three months.
- Clinical diagnosis of bilateral arthrogenous disorder and myalgia.
- Moreover, TMD can be confirmed by diagnosis through MRI and CT examinations
- Pregnancy or lactation.
- Previous mandible or significant facial trauma.
Key exclusion criteria (1 listed)
- -
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 (BoNT-A)Participants will receive a total dose of 100 units of Botulinum Toxin Type A (BoNT-A) administered by intramuscular injection into the bilateral masseter and temporalis muscles (25 U per side in each muscle). The injections will be performed using a 31G × 12 mm needle. Participants will be followed at 1 week, 1 month, and 3 months to assess pain intensity and maximal interincisal mouth opening. | Drug | Botulinum Toxin Type A (BoNT-A) |
| 0.9% Normal Saline (Placebo)Participants will receive 0.9% normal saline by intramuscular injection into the bilateral masseter and temporalis muscles using the same injection technique, volume, and follow-up schedule as the experimental group. The placebo is used to maintain blinding and serve as the comparator. | Drug | Placebo (0.9% Normal Saline) |
Primary outcome
Pain Intensity Numerical Rating Scale
Time frame: 1 week, 1 month, and 3 months after injection.
Changes in pain intensity can be measured using various scales, such as the 11-point Pain Intensity Numerical Rating Scale (PI-NRS), where 0=no pain and 10=worst possible pain. The PI-NRS is commonly used to assess pain intensity in chronic pain management. However, interpreting the clinical importance of changes from baseline on this scale can be challenging. Studies have estimated a clinically important difference on the PI-NRS by relating it to global assessments of change in multiple studies of chronic pain.
Change in maximal interincisal mouth opening (MIO)
Time frame: 1 week, 1 month, and 3 months after injection.
The maximum interincisal distance (MID) is a crucial measurement for assessing the function of the temporomandibular joint (TMJ) and the masticatory muscles. It is measured by the distance between the upper and lower incisors when the mouth is fully opened. This measurement is particularly important in evaluating TMJ disorders and can indicate the health of the jaw and its associated muscles.
2 secondary outcomes
Incidence of adverse events
Time frame: hroughout the 3-month follow-up period.
Pain during mandibular movements
Time frame: 1 week, 1 month, and 3 months.
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 29 Sep 2026.
- 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.
Uzair Luqman, FCPS principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Botulinum Toxin Type A (BoNT-A) in people with Temporomandibular Disorder, run by Riphah International University at 1 site in Pakistan.
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 7 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: looking for participants now, as of the sponsor's last update on 29 Sep 2026. 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 Pakistan. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Muhammad Sohaib Arshad (+923345635938, muhammadsohaibarshad542@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity Numerical Rating Scale (time frame: 1 week, 1 month, and 3 months after injection.). 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 29 Sep 2026.