TMJ PainPhase 2/3NCT07445191
Efficacy of Triamcinolone-Lidocaine Mix in Trigger Points Injection of Masseter Muscle: Double-blinded, Randomized Controlled Trial
A Phase 2/3 study testing Saline, Triamcinolone with lidocaine and Lidocaine in people with TMJ Pain, run by Cairo University.
Trial summary
This study aims to clinically evaluate the efficacy of trigger points using active drug mix (Triamcinolone with lidocaine) on relief of myofascial pain of jaw muscle. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- TMJ Pain
- What is being tested?
- Saline, Triamcinolone with lidocaine and Lidocaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2026to 1 Jul 2026
- Phase
- Phase 2/3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age more than or equal 18 years
- Both sexes
- Patients' willingness to follow instructions
Who cannot join
- Patients who will be using any medications to reduce the pain and/or have any effect on the skeletal muscle
- Clinical conditions such as pregnancy
- Medical problems that may interfere with the procedures such as bleeding disorders
- Cognitive impairment or exhibited inadequate cooperation
- Patients will be receiving physical therapy or wearing occlusal splint in the same period of the research
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Ammar Ali Mudhsh Al-Hawbani Ammar Ali Mudhsh Al-Hawbani, bachelor's degree contact
Hamida Refai Hasanien Hasanien professor, phd contact
About this study
Official title: Clinical Assessment of The Efficacy of Triamcinolone-Lidocaine Mix in Trigger Points Injection of Masseter Muscle: Double-blinded, Randomized Controlled Trial
This study aims to clinically evaluate the efficacy of trigger points using active drug mix (Triamcinolone with lidocaine) on relief of myofascial pain of jaw muscle.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SalineDrug
Patients will take 1 ml of lidocaine 2%
Triamcinolone with lidocaineDrug
Patients will take 1 ml of active drug mix (1/4 ml of Triamcinolone and 3/4 ml of lidocaine)
LidocaineDrug
Patients will take 1 ml lidocaine 2%
| Study group | Role | What they receive |
|---|---|---|
| Saline | Active comparator | Not described Receives: Drug: Saline |
| Triamcinolone with lidocaine | Experimental | Not described Receives: Drug: Triamcinolone with lidocaine |
| Lidocaine | Experimental | Not described Receives: Drug: Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
current pain intensity
- Patients' subjective pain experience. Each patient will be asked to rate his or her current and worst pain intensity on visual analogue scale (VAS) of 0-10 with zero being no pain and ten corresponds to the worst pain that the patient ever had
Measured: 1 week , 1 month , 3 months after treatment
Secondary outcomes (4)
maximum mouth opening
- Maximum mouth opening (MMO). Assessment of MMO will be performed by measuring the distance in mm between the incisal edges of the upper and lower central incisors using a ruler.
- The postoperative demand for analgesics will be evaluated by recording the number of the analgesic's intake.
- Patient satisfaction.
- Pressure pain threshold (PPT).
Data will be collected preoperatively, pain will be measured immediately after the treatment, as well as one week, one month, and 3 months after the end of the treatment sessions
Measured: 1 week , 1 month , 3 months after treatment
post operative demands for analgesics
measuring unit number
Measured: 1 week , 1 month , 3 months after treatment
patient satisfaction
measured by likert scale
Measured: 1 week , 1 month , 3 months after treatment
pressure pain threshold (PPT)
measuresd by algometer
Measured: 1 week , 1 month , 3 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start1 Mar 2026 (estimated)
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TMJ PainStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ammar Ali Mudhsh Al hawbani, Cairo University
- Investigators
- Hamida Refai Hasanien Hasanien Hamida Refai Hasanien, phd, Study director, cair university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07445191
- Sponsor's protocol ID
- injection of masseter muscle
- Status last verified
- Feb 2026
- First submitted
- 24 Feb 2026
- Last updated
- 3 Mar 2026
- Results posted
- 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 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Assessment of The Efficacy of Triamcinolone-Lidocaine Mix in Trigger Points Injection of Masseter Muscle: Double-blinded, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07445191
- Acronym / sponsor ID
- injection of masseter muscle
- Conditions
- TMJ Pain
- Keywords
- masseter muscle
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 3 Mar 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 aims to clinically evaluate the efficacy of trigger points using active drug mix (Triamcinolone with lidocaine) on relief of myofascial pain of jaw muscle.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Saline | Active comparator | Drug: Saline |
| Triamcinolone with lidocaine | Experimental | Drug: Triamcinolone with lidocaine |
| Lidocaine | Experimental | Drug: Lidocaine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age more than or equal 18 years
- Both sexes
- Patients' willingness to follow instructions
Key exclusion criteria (5 listed)
- Patients who will be using any medications to reduce the pain and/or have any effect on the skeletal muscle
- Clinical conditions such as pregnancy
- Medical problems that may interfere with the procedures such as bleeding disorders
- Cognitive impairment or exhibited inadequate cooperation
- Patients will be receiving physical therapy or wearing occlusal splint in the same period of the research
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 |
|---|---|---|
| SalinePatients will take 1 ml of lidocaine 2% | Drug | Saline |
| Triamcinolone with lidocainePatients will take 1 ml of active drug mix (1/4 ml of Triamcinolone and 3/4 ml of lidocaine) | Drug | Triamcinolone with lidocaine |
| LidocainePatients will take 1 ml lidocaine 2% | Drug | Lidocaine |
Primary outcome
current pain intensity
Time frame: 1 week , 1 month , 3 months after treatment
• Patients' subjective pain experience. Each patient will be asked to rate his or her current and worst pain intensity on visual analogue scale (VAS) of 0-10 with zero being no pain and ten corresponds to the worst pain that the patient ever had
4 secondary outcomes
maximum mouth opening
Time frame: 1 week , 1 month , 3 months after treatment
post operative demands for analgesics
Time frame: 1 week , 1 month , 3 months after treatment
patient satisfaction
Time frame: 1 week , 1 month , 3 months after treatment
pressure pain threshold (PPT)
Time frame: 1 week , 1 month , 3 months after treatment
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 3 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for TMJ Pain
Recruiting
Photobiomodulation for Management of Temporomandibular Disorder Pain
Pain Related to TMD
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
Not yet recruiting
Comparing Dextrose Prolotherapy vs. Sodium Hyaluronic Acid Injections for Jaw Joint Internal Derangement
Temporomandibular Joint Internal Derangement, TMJ-ID
Recruiting
R01_Pilot Jaw Muscle Phenotypes
Chronic TMD Pain, Temporomandibular Disorder
Recruiting
Evaluation of the Effect of Adding Sodium Bicarbonate to Lidocaine in the Treatment of Myofascial Pain Syndrome
Myofacial Pain, Myofacial Pain Syndrome
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.
Ammar Ali Mudhsh Al-Hawbani Ammar Ali Mudhsh Al-Hawbani, bachelor's degree contact
Hamida Refai Hasanien Hasanien professor, phd contact
Hamida Refai Hasanien Hasanien Hamida Refai Hasanien, phd study director
cair university
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Saline, Triamcinolone with lidocaine and Lidocaine in people with TMJ Pain, 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 3 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 3 Mar 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.
What does this combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Ammar Ali Mudhsh Al-Hawbani Ammar Ali Mudhsh Al-Hawbani, bachelor's degree (0103052078, prof.hamidarefaee@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
current pain intensity (time frame: 1 week , 1 month , 3 months after treatment). 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 3 Mar 2026.