Post Operative PainPhase 2NCT07094542
Jaw Muscle Pain Post Wisdom Molar Surgery
A Phase 2 study testing Temporo-masseteric Nerve Block Injection and Oral Pain Medications only in people with Post Operative Pain and Impacted Third Molar Tooth, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial summary
The proposed design is a triple-blind, placebo-controlled randomized prospective phase II trial to assess the feasibility of employing the Temporo-masseteric Nerve Block (TMNB) injection to decrease jaw muscle pain, overall pain, improve mouth opening and minimize pain medication consumption. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Operative Pain, Impacted Third Molar Tooth, Muscle Pain
- What is being tested?
- Temporo-masseteric Nerve Block Injection and Oral Pain Medications only
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2026to May 2030
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients recommended extraction/s of at least 1 lower wisdom (third) molar that is partially/fully 'impacted' under intravenous sedation, are eligible to participate in this study so long as they
- are 18 years or older,
- are healthy,
- have no cognitive/intellectual disability,
- have no past/recent pain or reduced range of motion in their jaw joint/ muscle complex, no trauma or surgery in their jaw region.
- have an electronic device such as a smart phone or a tablet/ computer with internet connection.
- are willing to participate in the study and not be excluded by the following criteria below.
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Compromised ability to guard their self-interest, for e.g., prisoners, children, pregnant women, patients with intellectual/cognitive disability are not enrolled in the study.
- Those patients who present with infection/inflammation involving the third molars slated for extractions, on the day of their procedure, may not take part in the study.
- Those who have had opioid pain medication/s in the past 3 months to address short term or long-standing pain, or those who are on long term prescription of anti-inflammatory pain medication, are unable to participate.
- Those with long standing painful limitation of movement of the jaw joint or muscles.
- Those patients who are allergic to/unable to tolerate either the dental local anesthetic or its components, opioids, acetaminophen or ibuprofen also may not take part in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Rutgers School of Dental Medicine
Newark, New Jersey, 07103
About this study
Official title: Temporo-masseteric Nerve Block in Post-wisdom Tooth Extraction Pain- a Randomized Study
The proposed design is a triple-blind, placebo-controlled randomized prospective phase II trial to assess the feasibility of employing the Temporo-masseteric Nerve Block (TMNB) injection to decrease jaw muscle pain, overall pain, improve mouth opening and minimize pain medication consumption. 80 participants undergoing lower third molar removal under sedation will be enrolled. Those who develop significant jaw muscle pain on the following day will be randomized to receive either the TMNB injection or a placebo. Daily ecological momentary assessments (EMAs) will be collected reflecting elements of patient experience for all participants. On Day 8, participants return for an end-of-study evaluation and return their unused pain medications. Up to 40 participants who are randomized to receive TMNB/placebo will be recruited to participate in a qualitative interview regarding their experience.
Read the detailed description
The study is designed as a parallel, blinded, randomized phase II pilot study to assess the ability of the Temporo-masseteric Nerve Block (TMNB) injection to reduce post-operative pain in patients who undergo removal of lower third molar/s under sedation. It is not known how often and in whom jaw muscle pain significantly contributes to post-operative pain, limitation in mouth opening, and function. and develop significant jaw muscle pain. Hence the study is designed to assess the development of such jaw muscle pain before testing the placebo-controlled TMNB intervention. Accordingly, 80 subjects who undergo lower third molar extractions under intravenous sedation are randomized to receive either the TMNB (standard-of-care local anesthetic, 1.8 ml 2% lidocaine with 1:100,000 epinephrine), or a placebo (TMNB injection technique, but with 1.8 ml of sterile isotonic saline instead) the day following their extraction/s should they report significant pain (≥5 on a scale of pain rating from 0 to 10) when the jaw muscles are 'palpated' or examined with firm finger pressure. The assessment will be repeated 15 minutes after the injection. On the other hand, those who report less pain (<5) to jaw muscle palpation will not receive any injection. The participant, TMNB administrator and the evaluator will be blinded from randomization assignment. All participants will fill out daily remote surveys administered through REDCap® that will assess peak NRS pain score for the previous 24 hours, limitation in mouth opening and function, oral health related quality of life, pain medication consumption, and adverse effects from pain medications. Patient responses will be collected remotely and will include patient-uploaded cropped selfies of spontaneous mouth-opening with a disposable millimeter ruler (Orastretch®) propped between the upper and lower incisors.
It is anticipated that approximately 50% of patients will develop significant jaw muscle pain following the procedure. Hence, of the 80 participants, 40 are anticipated to be eligible for randomization, with 20 participants receiving the placebo or the TMNB injection, respectively.
Participants will return for an in-person assessment on Day 8, will return unused medications and will get an opportunity to participate in a qualitative interview to interrogate their experience receiving the injection (those randomized to TMNB/placebo), and their recovery experience. The duration of participation is a week from undergoing the procedure.
- Conditions
- Post Operative Pain, Impacted Third Molar Tooth, Muscle Pain
- Being tested
- Temporo-masseteric Nerve Block Injection, Oral Pain Medications only
- Keywords
- Temporo-masseteric Nerve Block, Jaw muscle pain
- Medical subject headings
- Pain, Postoperative, Myalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Temporo-masseteric Nerve Block InjectionDrug
Also called TMNB, Twin Block
The TMNB injection/placebo will be administered by the Principal Investigator. The injection will only be delivered on Day 2 on the side/s of significant jaw muscle pain. Following disinfection of skin overlying the suprazygomatic injection site, a single carpule of 1.8 ml 2% lidocaine with 1:100,000 epinephrine will be delivered using a 25- or 27- gauge 30 mm needle). The injection site will be approximately a centimeter above the zygomatic arch, and a centimeter behind the palpable posterior border of the frontal process of the zygomatic bone. The needle will be directed at a 45-degree downward angle, directed medially along the coronal plane. At the depth of insertion of the needle, the local anesthetic/placebo will be delivered.
Oral Pain Medications onlyDrug
For participants with jaw muscle pain to palpation <5 NRS score, no additional injection will be given. The participant will take the recommended pain medications as described.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Participants whose jaw muscle pain to palpation is <5 on Numerical Pain Rating Scale (NRS) the day after lower wisdom molar removal under sedation will be recommended post-operative pain management with a fixed interval dosing of ibuprofen 600 mg along with acetaminophen 325 mg taken every 6 hours for the first 72 hours post-procedure, after which they are encouraged to take prn dosing. Receives: Drug: Oral Pain Medications only |
| TMNB with Placebo | Active comparator | Participants whose jaw muscle pain to palpation is 5 or higher on on Numerical Pain Rating Scale (NRS) the day after lower wisdom molar removal under sedation will be randomized to either placebo (sterile saline) or to the dental local anesthetic. The placebo will be delivered as the Temporo-masseteric Nerve Block injection. The randomization is blind to the participant and to the investigator administering the injection. The participants will be recommended post-operative pain management with a fixed interval dosing of ibuprofen 600 mg along with acetaminophen 325 mg taken every 6 hours for the first 72 hours post-procedure, after which they are encouraged to take prn dosing. Receives: Drug: Temporo-masseteric Nerve Block Injection |
| TMNB with dental local anesthetic | Experimental | Participants whose jaw muscle pain to palpation is 5 or higher on on Numerical Pain Rating Scale (NRS) the day after lower wisdom molar removal under sedation will be randomized to either placebo (sterile saline) or to the dental local anesthetic. The dental local anesthetic (2% lidocaine with 1:100,000 epinephrine) will be delivered as the Temporo-masseteric Nerve Block injection. The randomization is blind to the participant and to the investigator administering the injection. The participants will be recommended post-operative pain management with a fixed interval dosing of ibuprofen 600 mg along with acetaminophen 325 mg taken every 6 hours for the first 72 hours post-procedure, after which they are encouraged to take prn dosing. Receives: Drug: Temporo-masseteric Nerve Block Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Jaw Muscle Pain Reduction on palpation post-TMNB injections
To assess the effect of TMNB injection on the Numerical Pain Rating Scale (NRS) corresponding to Jaw muscle pain-to-palpation reported by the participant, when assessed 15 minutes post-injection.
Measured: Day 2 15 minutes post TMNB injection
Secondary outcomes (3)
Sustained Benefit from TMNB Injection- pain reduction
Comparison of peak NRS pain score, the highest pain level as perceived by the participant collected for the preceding 24 hours.
Measured: 24-, 48-, 72-, and 96- hours post-injection
Sustained Benefit from TMNB Injection- mouth opening
Comparison of spontaneous maximum mouth opening, measured in millimeters
Measured: 24-, 48-, 72-, and 96- hours post-injection
Opioid consumption to 'rescue' pain poorly responsive to recommended pain medication regimen
Compare need for rescue opioid medication among the three groups
Measured: 8 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2025
- Study startSep 2026 (estimated)
- Primary completionNov 2029 (estimated)
- Study completionMay 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Post Operative PainStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Responsible party
- Principal investigator, Gayathri Subramanian, Rutgers, The State University of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07094542
- Sponsor's protocol ID
- Pro2024001685
- Status last verified
- Jun 2026
- First submitted
- 23 Jul 2025
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Final results will be posted no later than 12 months after the trial's primary completion date and will include participant flow, demographic and baseline characteristics, outcomes and statistical analyses, adverse events, the protocol, statistical analysis plan and administrative information. The PI will share the individual non-identified subject data no later than acceptance for the publication's main findings from the final data analysis or 18 months after completion of the study, whichever is earlier. Data to be posted will include the study protocol, reference to study publication of primary outcome variable, the data set in both SAS and ASCII formats, data dictionary and study specific de-identification notes.
Publications
Subramanian G, Quek SYP. The Temporo-Masseteric Nerve Block (TMNB) for Alleviating Acute Postextraction Masticatory Myalgia: A Case Series. Anesth Prog. 2025 Mar 12;72(1):37-42. doi: 10.2344/24-0001.
PubMed 40657832Subramanian G, Makhija D, Ananthan S, Stitik TP, Quek SYP. Safety, efficacy, and mechanism of action of the temporo-masseteric nerve block. J Oral Facial Pain Headache. 2024 Jun;38(2):68-73. doi: 10.22514/jofph.2024.014. Epub 2024 Jun 12.
PubMed 39801096Quek SYP, Gomes-Zagury J, Subramanian G. Twin Block in Myogenous Orofacial Pain: Applied Anatomy, Technique Update, and Safety. Anesth Prog. 2020 Jun 1;67(2):103-106. doi: 10.2344/anpr-67-01-03.
PubMed 32633773Kanti V, Ananthan S, Subramanian G, Quek SYP. Efficacy of the twin block, a peripheral nerve block for the management of chronic masticatory myofascial pain: A case series. Quintessence Int. 2017 Oct 6:725-729. doi: 10.3290/j.qi.a39094. Online ahead of print.
PubMed 28990015Ananthan S, Kanti V, Zagury JG, Quek SYP, Benoliel R. The effect of the twin block compared with trigger point injections in patients with masticatory myofascial pain: a pilot study. Oral Surg Oral Med Oral Pathol Oral Radiol. 2020 Mar;129(3):222-228. doi: 10.1016/j.oooo.2019.09.014. Epub 2019 Oct 13.
PubMed 32009005
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Temporo-masseteric Nerve Block in Post-wisdom Tooth Extraction Pain- a Randomized Study
- ClinicalTrials.gov ID
- NCT07094542
- Acronym / sponsor ID
- Pro2024001685
- Conditions
- Post Operative Pain, Impacted Third Molar Tooth, Muscle Pain
- Keywords
- Temporo-masseteric Nerve Block, Jaw muscle pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Study start
- Sep 2026 (estimated)
- Primary completion
- Nov 2029 (estimated)
- Study completion
- May 2030 (estimated)
- First posted
- 30 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.
The proposed design is a triple-blind, placebo-controlled randomized prospective phase II trial to assess the feasibility of employing the Temporo-masseteric Nerve Block (TMNB) injection to decrease jaw muscle pain, overall pain, improve mouth opening and minimize pain medication consumption. 80 participants undergoing lower third molar removal under sedation will be enrolled. Those who develop significant jaw muscle pain on the following day will be randomized to receive either the TMNB injection or a placebo. Daily ecological momentary assessments (EMAs) will be collected reflecting elements of patient experience for all participants. On Day 8, participants return for an end-of-study evaluation and return their unused pain medications. Up to 40 participants who are randomized to receive TMNB/placebo will be recruited to participate in a qualitative interview regarding their experience.
Detailed description
The study is designed as a parallel, blinded, randomized phase II pilot study to assess the ability of the Temporo-masseteric Nerve Block (TMNB) injection to reduce post-operative pain in patients who undergo removal of lower third molar/s under sedation. It is not known how often and in whom jaw muscle pain significantly contributes to post-operative pain, limitation in mouth opening, and function. and develop significant jaw muscle pain. Hence the study is designed to assess the development of such jaw muscle pain before testing the placebo-controlled TMNB intervention. Accordingly, 80 subjects who undergo lower third molar extractions under intravenous sedation are randomized to receive either the TMNB (standard-of-care local anesthetic, 1.8 ml 2% lidocaine with 1:100,000 epinephrine), or a placebo (TMNB injection technique, but with 1.8 ml of sterile isotonic saline instead) the day following their extraction/s should they report significant pain (≥5 on a scale of pain rating from 0 to 10) when the jaw muscles are 'palpated' or examined with firm finger pressure. The assessment will be repeated 15 minutes after the injection. On the other hand, those who report less pain (<5) to jaw muscle palpation will not receive any injection. The participant, TMNB administrator and the evaluator will be blinded from randomization assignment. All participants will fill out daily remote surveys administered through REDCap® that will assess peak NRS pain score for the previous 24 hours, limitation in mouth opening and function, oral health related quality of life, pain medication consumption, and adverse effects from pain medications. Patient responses will be collected remotely and will include patient-uploaded cropped selfies of spontaneous mouth-opening with a disposable millimeter ruler (Orastretch®) propped between the upper and lower incisors.
It is anticipated that approximately 50% of patients will develop significant jaw muscle pain following the procedure. Hence, of the 80 participants, 40 are anticipated to be eligible for randomization, with 20 participants receiving the placebo or the TMNB injection, respectively.
Participants will return for an in-person assessment on Day 8, will return unused medications and will get an opportunity to participate in a qualitative interview to interrogate their experience receiving the injection (those randomized to TMNB/placebo), and their recovery experience. The duration of participation is a week from undergoing the procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Drug: Oral Pain Medications onlyParticipants whose jaw muscle pain to palpation is <5 on Numerical Pain Rating Scale (NRS) the day after lower wisdom molar removal under sedation will be recommended post-operative pain management with a fixed interval dosing of ibuprofen 600 mg along with acetaminophen 325 mg taken every 6 hours for the first 72 hours post-procedure, after which they are encouraged to take prn dosing. |
| TMNB with Placebo | Active comparator | Drug: Temporo-masseteric Nerve Block InjectionParticipants whose jaw muscle pain to palpation is 5 or higher on on Numerical Pain Rating Scale (NRS) the day after lower wisdom molar removal under sedation will be randomized to either placebo (sterile saline) or to the dental local anesthetic. The placebo will be delivered as the Temporo-masseteric Nerve Block injection. The randomization is blind to the participant and to the investigator administering the injection. The participants will be recommended post-operative pain management with a fixed interval dosing of ibuprofen 600 mg along with acetaminophen 325 mg taken every 6 hours for the first 72 hours post-procedure, after which they are encouraged to take prn dosing. |
| TMNB with dental local anesthetic | Experimental | Drug: Temporo-masseteric Nerve Block InjectionParticipants whose jaw muscle pain to palpation is 5 or higher on on Numerical Pain Rating Scale (NRS) the day after lower wisdom molar removal under sedation will be randomized to either placebo (sterile saline) or to the dental local anesthetic. The dental local anesthetic (2% lidocaine with 1:100,000 epinephrine) will be delivered as the Temporo-masseteric Nerve Block injection. The randomization is blind to the participant and to the investigator administering the injection. The participants will be recommended post-operative pain management with a fixed interval dosing of ibuprofen 600 mg along with acetaminophen 325 mg taken every 6 hours for the first 72 hours post-procedure, after which they are encouraged to take prn dosing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- All patients recommended extraction/s of at least 1 lower wisdom (third) molar that is partially/fully 'impacted' under intravenous sedation, are eligible to participate in this study so long as they
- are 18 years or older,
- are healthy,
- have no cognitive/intellectual disability,
- have no past/recent pain or reduced range of motion in their jaw joint/ muscle complex, no trauma or surgery in their jaw region.
Key exclusion criteria (6 listed)
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Compromised ability to guard their self-interest, for e.g., prisoners, children, pregnant women, patients with intellectual/cognitive disability are not enrolled in the study.
- Those patients who present with infection/inflammation involving the third molars slated for extractions, on the day of their procedure, may not take part in the study.
- Those who have had opioid pain medication/s in the past 3 months to address short term or long-standing pain, or those who are on long term prescription of anti-inflammatory pain medication, are unable to participate.
- Those with long standing painful limitation of movement of the jaw joint or muscles.
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 |
|---|---|---|
| Temporo-masseteric Nerve Block InjectionAlso: TMNB, Twin BlockThe TMNB injection/placebo will be administered by the Principal Investigator. The injection will only be delivered on Day 2 on the side/s of significant jaw muscle pain. Following disinfection of skin overlying the suprazygomatic injection site, a single carpule of 1.8 ml 2% lidocaine with 1:100,000 epinephrine will be delivered using a 25- or 27- gauge 30 mm needle). The injection site will be approximately a centimeter above the zygomatic arch, and a centimeter behind the palpable posterior border of the frontal process of the zygomatic bone. The needle will be directed at a 45-degree downward angle, directed medially along the coronal plane. At the depth of insertion of the needle, the local anesthetic/placebo will be delivered. | Drug | TMNB with Placebo, TMNB with dental local anesthetic |
| Oral Pain Medications onlyFor participants with jaw muscle pain to palpation <5 NRS score, no additional injection will be given. The participant will take the recommended pain medications as described. | Drug | Control |
Primary outcome
Jaw Muscle Pain Reduction on palpation post-TMNB injections
Time frame: Day 2 15 minutes post TMNB injection
To assess the effect of TMNB injection on the Numerical Pain Rating Scale (NRS) corresponding to Jaw muscle pain-to-palpation reported by the participant, when assessed 15 minutes post-injection.
3 secondary outcomes
Sustained Benefit from TMNB Injection- pain reduction
Time frame: 24-, 48-, 72-, and 96- hours post-injection
Sustained Benefit from TMNB Injection- mouth opening
Time frame: 24-, 48-, 72-, and 96- hours post-injection
Opioid consumption to 'rescue' pain poorly responsive to recommended pain medication regimen
Time frame: 8 Days
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 18 Jun 2026.
- Background: PubMed 40657832Subramanian G, Quek SYP. The Temporo-Masseteric Nerve Block (TMNB) for Alleviating Acute Postextraction Masticatory Myalgia: A Case Series. Anesth Prog. 2025 Mar 12;72(1):37-42. doi: 10.2344/24-0001.
- Background: PubMed 39801096Subramanian G, Makhija D, Ananthan S, Stitik TP, Quek SYP. Safety, efficacy, and mechanism of action of the temporo-masseteric nerve block. J Oral Facial Pain Headache. 2024 Jun;38(2):68-73. doi: 10.22514/jofph.2024.014. Epub 2024 Jun 12.
- Background: PubMed 32633773Quek SYP, Gomes-Zagury J, Subramanian G. Twin Block in Myogenous Orofacial Pain: Applied Anatomy, Technique Update, and Safety. Anesth Prog. 2020 Jun 1;67(2):103-106. doi: 10.2344/anpr-67-01-03.
- Background: PubMed 28990015Kanti V, Ananthan S, Subramanian G, Quek SYP. Efficacy of the twin block, a peripheral nerve block for the management of chronic masticatory myofascial pain: A case series. Quintessence Int. 2017 Oct 6:725-729. doi: 10.3290/j.qi.a39094. Online ahead of print.
- Background: PubMed 32009005Ananthan S, Kanti V, Zagury JG, Quek SYP, Benoliel R. The effect of the twin block compared with trigger point injections in patients with masticatory myofascial pain: a pilot study. Oral Surg Oral Med Oral Pathol Oral Radiol. 2020 Mar;129(3):222-228. doi: 10.1016/j.oooo.2019.09.014. Epub 2019 Oct 13.
- Individual participant dataSharing planned: Yes. Final results will be posted no later than 12 months after the trial's primary completion date and will include participant flow, demographic and baseline characteristics, outcomes and statistical analyses, adverse events, the protocol, statistical analysis plan and administrative information. The PI will share the individual non-identified subject data no later than acceptance for the publication's main findings from the final data analysis or 18 months after completion of the study, whichever is earlier. Data to be posted will include the study protocol, reference to study publication of primary outcome variable, the data set in both SAS and ASCII formats, data dictionary and study specific de-identification notes.
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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.
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 Temporo-masseteric Nerve Block Injection and Oral Pain Medications only in people with Post Operative Pain and Impacted Third Molar Tooth, run by Rutgers, The State University of New Jersey at 1 site in United States.
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 6 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 18 Jun 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 United States. 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.
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 Gayathri D Subramanian, PhD, DMD (7328247241, subramga@sdm.rutgers.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Jaw Muscle Pain Reduction on palpation post-TMNB injections (time frame: Day 2 15 minutes post TMNB injection). 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 NCT07094542, which also lists 5 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 18 Jun 2026.