Acute PainPhase 2NCT05335070
Reducing Pain From Wisdom Molar Extractions
A Phase 2 study testing Temporo-masseteric Nerve Block in people with Acute Pain, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial summary
This is a pilot study evaluating the ability of the Temporo-masseteric Nerve Block local anesthetic injection (this was called the Twin Block earlier) to reduce pain experienced by individuals undergoing removal of lower third molar(s) under intravenous sedation. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Acute Pain
- What is being tested?
- Temporo-masseteric Nerve Block
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Sep 2022to 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18 years of age or older (up to 64 years)
- Any demographic
- ASA 1 and 2 (mild or absent systemic illnesses, deemed fit for undergoing dental extractions under intravenous sedation)
- Not pregnant (as will not qualify to undergo procedure under intravenous sedation as part of routine standard-of-care)
- Adequate mental ability to understand and provide informed consent
- Has smart phone and internet connection
Who cannot join
- Age older than 64 years (because they are poor candidates for undergoing procedures under intravenous sedation)
- Pregnant
- Incapable of providing informed consent
- Any systemic condition that renders the patient at higher risk for complications under intravenous sedation
- Documented allergy to the dental local anesthetic
- Inability to tolerate any of the commonly used pain medications such as combination opioids, acetaminophen (Tylenol®) or ibuprofen (Motrin® or Advil®)
- Limitation in adequate mouth opening in presence/absence of pain
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Samuel YP Quek, DMD, MPH contact
United States1 site, 1 recruiting
- Recruiting
The University Hospital- Dental Clinic
Newark, New Jersey, 07103
Gayathri Subramanian, 973-972-3418, subramga@sdm.rutgers.edu
About this study
Official title: Non-randomized Prospective Pilot Study on Effect of Temporo-masseteric Nerve Block (TMNB) on Pain Reduction Following Wisdom Molar Extractions
This is a pilot study evaluating the ability of the Temporo-masseteric Nerve Block local anesthetic injection (this was called the Twin Block earlier) to reduce pain experienced by individuals undergoing removal of lower third molar(s) under intravenous sedation. Study participants will be queried for pain experience and pain medications taken during the first post-operative week and will present for a follow-up visit on Day 8.
Read the detailed description
Each year, over 3.5 million, mostly, healthy young adults, have their third molar teeth ('wisdom teeth') removed under sedation and are often given opioid prescriptions for managing their pain. Wisdom molar removal is one of the most common reasons for opioid prescriptions to be given to adolescents. There is a national thrust to reduce both the dose and the duration of such opioid prescriptions because even short-term opioid exposures increase risk for narcotic addiction and misuse. Non-opioid options to manage pain will still allow for sufficient pain control without risking addiction, and hence, a fundamental component of our response to combat the current national opioid crisis.
The investigators are going to study a promising option- the Temporo-masseteric Nerve Block (TMNB) dental anesthetic injection (This was called the Twin Block earlier). The TMNB involves injecting the standard dental numbing medication in a way that 'numbs' the 'jaw-clencher' muscles on the side of the face. The investigators found that the TMNB relieved jaw pain stemming from these muscles, in a quick and sustained manner, even in patients whose pain following wisdom tooth removal primarily came from 'taut' and tender jaw-clencher muscles.
In this pilot study, the investigators will deliver the Temporo-masseteric Nerve Block (TMNB) injection to 20 individuals (study participants) who undergo extraction of at least 1 lower wisdom molar dental extraction under intravenous sedation, on the side/s of lower molar removal at the end of the procedure. The participant's pain experience, medications taken for pain, as well as any adverse effects from either pain medications or the TMNB injection will be queried for a period of 1 week following the procedure (remotely). On Day 8 (one week after the procedure), the participants will return for a follow-up visit. The participants' pain experience will be compared with historical controls. This study can support a simple, safe and inexpensive means to reduce pain after a common procedure and will provide proof-of-concept for the potential non-opioid analgesic role of TMNB injection following wisdom molar removal.
The participant will be advised to take a combination of ibuprofen and acetaminophen (600 mg ibuprofen and 325 mg acetaminophen) every 4-6 hours for pain, unless it is mild, for which OTC strength analgesics would prove adequate (ibuprofen or acetaminophen). 5/300 mg hydrocodone with acetaminophen will be utilized for pain management if the patient's pain does not respond to 600 mg ibuprofen and 325 mg acetaminophen, even an hour after medication.
The key outcomes collected will include peak-pain by 4 hours post-procedure (measured using numerical pain rating scale score NRS, from 0-10, with 0 corresponding to no pain, 1-3 corresponding to mild, 4-6 to moderate and 7-10 to severe pain), passive mouth opening, masticatory muscle pain to palpation (masseter and temporalis muscles), total dosage of pain medication/s consumed. Adverse effects to pain medication consumption (nausea/ drowsiness/ gastritis etc) or to the TMNB injection will also be recorded. Daily pain experience will be recorded each of the 7 days post-operatively either as a survey emailed to the participant or queried over the phone by research personnel.
A week after the procedure, the participant will present for a post-operative evaluation. The extraction/s site/s will be evaluated for any infection/delayed healing.
- Conditions
- Acute Pain
- Being tested
- Temporo-masseteric Nerve Block
- Keywords
- Temporo-masseteric Nerve Block, Twin Block, Prescription opioids, Acute Post-extraction pain
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Temporo-masseteric Nerve BlockDrug
Following lower third molar extraction under intravenous sedation, the patient will receive the TMNB local anesthetic nerve block using the standard dental local anesthetic, i.e,. 2% lidocaine with 1:100,000 epinephrine on the side/s of the lower wisdom molar (third molar) extraction/s
| Study group | Role | What they receive |
|---|---|---|
| Temporo-masseteric Nerve Block (TMNB) Injection with Local Anesthetic | Experimental | Following lower third molar extraction under intravenous sedation, the patient will receive the TMNB local anesthetic nerve block using the standard dental local anesthetic, i.e,. 2% lidocaine with 1:100,000 epinephrine, on the side/s of lower wisdom molar extraction/s Receives: Drug: Temporo-masseteric Nerve Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak post-operative Pain Score
Every 30 minutes, the patient's pain score (Numerical Pain Rating Scale with scores from 0-10, (the NRS scale), with 0= no pain, 1-3= mild pain, 4-6= moderate pain, 7-10= severe pain) will be recorded to document peak pain score by hour 4. If the patient were to report a score from 7-10 at any time, no additional delay/pain score enquiry will take place and the patient will be directed to take the first dose of post-operative pain medication as described elsewhere.
Measured: up to 4 hours on day of procedure, post-procedure
Mean Numerical Pain Rating Scale pain score
The average pain score reported by the patient during the entire post-operative week will be assessed
Measured: One week
Passive Mouth opening
Passive mouth opening will be measured (in mm) at baseline, post-procedure before as well as 15 min after TMNB injection and finally, during the post-operative visit (Day 8) will be measured
Measured: Baseline, post-procedure (Day 1) and at post-operative visit (Day 8)
Masticatory muscle pain to palpation- Temporalis and Masseter
Numerical pain rating scale pain scores reported by the patient upon palpation of the masseter and temporalis muscles will be recorded at baseline, post-procedure (before and 15 min after TMNB injection) and at the post-operative visit one week after procedure
Measured: Baseline, post-procedure (Day 1) and at post-operative visit (Day 8)
Total dose of pain medication- acetaminophen, ibuprofen and hydrocodone
Total dose of pain medications consumed over the first post-operative week, for each of the medications will be recorded in mg
Measured: 8 Days
Adverse effects
The patient will be queried each day for any adverse effects from pain medications and any adverse effects at the site of injection (infection, pain etc)
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 posted19 Apr 2022
- Study start13 Sep 2022
- Primary completionNov 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acute 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Prospective single-arm pilot study
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gayathri Subramanian, Rutgers, The State University of New Jersey
- Investigators
- Gayathri D Subramanian, PhD, DMD, Principal investigator, Rutgers School of Dental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05335070
- Sponsor's protocol ID
- Pro2021002543
- Status last verified
- Dec 2025
- First submitted
- 13 Apr 2022
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: After anonymizing, IPD will be shared after the study is completed.
Publications
Quek 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 28990015Quek S, Young A, Subramanian G. The twin block: a simple technique to block both the masseteric and the anterior deep temporal nerves with one anesthetic injection. Oral Surg Oral Med Oral Pathol Oral Radiol. 2014 Sep;118(3):e65-7. doi: 10.1016/j.oooo.2014.01.227. Epub 2014 Feb 6.
PubMed 24703404
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-randomized Prospective Pilot Study on Effect of Temporo-masseteric Nerve Block (TMNB) on Pain Reduction Following Wisdom Molar Extractions
- ClinicalTrials.gov ID
- NCT05335070
- Acronym / sponsor ID
- Pro2021002543
- Conditions
- Acute Pain
- Keywords
- Temporo-masseteric Nerve Block, Twin Block, Prescription opioids, Acute Post-extraction pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- 13 Sep 2022 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 19 Apr 2022 (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 is a pilot study evaluating the ability of the Temporo-masseteric Nerve Block local anesthetic injection (this was called the Twin Block earlier) to reduce pain experienced by individuals undergoing removal of lower third molar(s) under intravenous sedation. Study participants will be queried for pain experience and pain medications taken during the first post-operative week and will present for a follow-up visit on Day 8.
Detailed description
Each year, over 3.5 million, mostly, healthy young adults, have their third molar teeth ('wisdom teeth') removed under sedation and are often given opioid prescriptions for managing their pain. Wisdom molar removal is one of the most common reasons for opioid prescriptions to be given to adolescents. There is a national thrust to reduce both the dose and the duration of such opioid prescriptions because even short-term opioid exposures increase risk for narcotic addiction and misuse. Non-opioid options to manage pain will still allow for sufficient pain control without risking addiction, and hence, a fundamental component of our response to combat the current national opioid crisis.
The investigators are going to study a promising option- the Temporo-masseteric Nerve Block (TMNB) dental anesthetic injection (This was called the Twin Block earlier). The TMNB involves injecting the standard dental numbing medication in a way that 'numbs' the 'jaw-clencher' muscles on the side of the face. The investigators found that the TMNB relieved jaw pain stemming from these muscles, in a quick and sustained manner, even in patients whose pain following wisdom tooth removal primarily came from 'taut' and tender jaw-clencher muscles.
In this pilot study, the investigators will deliver the Temporo-masseteric Nerve Block (TMNB) injection to 20 individuals (study participants) who undergo extraction of at least 1 lower wisdom molar dental extraction under intravenous sedation, on the side/s of lower molar removal at the end of the procedure. The participant's pain experience, medications taken for pain, as well as any adverse effects from either pain medications or the TMNB injection will be queried for a period of 1 week following the procedure (remotely). On Day 8 (one week after the procedure), the participants will return for a follow-up visit. The participants' pain experience will be compared with historical controls. This study can support a simple, safe and inexpensive means to reduce pain after a common procedure and will provide proof-of-concept for the potential non-opioid analgesic role of TMNB injection following wisdom molar removal.
The participant will be advised to take a combination of ibuprofen and acetaminophen (600 mg ibuprofen and 325 mg acetaminophen) every 4-6 hours for pain, unless it is mild, for which OTC strength analgesics would prove adequate (ibuprofen or acetaminophen). 5/300 mg hydrocodone with acetaminophen will be utilized for pain management if the patient's pain does not respond to 600 mg ibuprofen and 325 mg acetaminophen, even an hour after medication.
The key outcomes collected will include peak-pain by 4 hours post-procedure (measured using numerical pain rating scale score NRS, from 0-10, with 0 corresponding to no pain, 1-3 corresponding to mild, 4-6 to moderate and 7-10 to severe pain), passive mouth opening, masticatory muscle pain to palpation (masseter and temporalis muscles), total dosage of pain medication/s consumed. Adverse effects to pain medication consumption (nausea/ drowsiness/ gastritis etc) or to the TMNB injection will also be recorded. Daily pain experience will be recorded each of the 7 days post-operatively either as a survey emailed to the participant or queried over the phone by research personnel.
A week after the procedure, the participant will present for a post-operative evaluation. The extraction/s site/s will be evaluated for any infection/delayed healing.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective single-arm pilot study
| Arm | Type | Receives |
|---|---|---|
| Temporo-masseteric Nerve Block (TMNB) Injection with Local Anesthetic | Experimental | Drug: Temporo-masseteric Nerve BlockFollowing lower third molar extraction under intravenous sedation, the patient will receive the TMNB local anesthetic nerve block using the standard dental local anesthetic, i.e,. 2% lidocaine with 1:100,000 epinephrine, on the side/s of lower wisdom molar extraction/s |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age 18 years of age or older (up to 64 years)
- Any demographic
- ASA 1 and 2 (mild or absent systemic illnesses, deemed fit for undergoing dental extractions under intravenous sedation)
- Not pregnant (as will not qualify to undergo procedure under intravenous sedation as part of routine standard-of-care)
- Adequate mental ability to understand and provide informed consent
Key exclusion criteria (7 listed)
- Age older than 64 years (because they are poor candidates for undergoing procedures under intravenous sedation)
- Pregnant
- Incapable of providing informed consent
- Any systemic condition that renders the patient at higher risk for complications under intravenous sedation
- Documented allergy to the dental local anesthetic
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 BlockFollowing lower third molar extraction under intravenous sedation, the patient will receive the TMNB local anesthetic nerve block using the standard dental local anesthetic, i.e,. 2% lidocaine with 1:100,000 epinephrine on the side/s of the lower wisdom molar (third molar) extraction/s | Drug | Temporo-masseteric Nerve Block (TMNB) Injection with Local Anesthetic |
Primary outcome
Peak post-operative Pain Score
Time frame: up to 4 hours on day of procedure, post-procedure
Every 30 minutes, the patient's pain score (Numerical Pain Rating Scale with scores from 0-10, (the NRS scale), with 0= no pain, 1-3= mild pain, 4-6= moderate pain, 7-10= severe pain) will be recorded to document peak pain score by hour 4. If the patient were to report a score from 7-10 at any time, no additional delay/pain score enquiry will take place and the patient will be directed to take the first dose of post-operative pain medication as described elsewhere.
Mean Numerical Pain Rating Scale pain score
Time frame: One week
The average pain score reported by the patient during the entire post-operative week will be assessed
Passive Mouth opening
Time frame: Baseline, post-procedure (Day 1) and at post-operative visit (Day 8)
Passive mouth opening will be measured (in mm) at baseline, post-procedure before as well as 15 min after TMNB injection and finally, during the post-operative visit (Day 8) will be measured
Masticatory muscle pain to palpation- Temporalis and Masseter
Time frame: Baseline, post-procedure (Day 1) and at post-operative visit (Day 8)
Numerical pain rating scale pain scores reported by the patient upon palpation of the masseter and temporalis muscles will be recorded at baseline, post-procedure (before and 15 min after TMNB injection) and at the post-operative visit one week after procedure
Total dose of pain medication- acetaminophen, ibuprofen and hydrocodone
Time frame: 8 Days
Total dose of pain medications consumed over the first post-operative week, for each of the medications will be recorded in mg
Adverse effects
Time frame: 8 days
The patient will be queried each day for any adverse effects from pain medications and any adverse effects at the site of injection (infection, pain etc)
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 5 Dec 2025.
- 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 24703404Quek S, Young A, Subramanian G. The twin block: a simple technique to block both the masseteric and the anterior deep temporal nerves with one anesthetic injection. Oral Surg Oral Med Oral Pathol Oral Radiol. 2014 Sep;118(3):e65-7. doi: 10.1016/j.oooo.2014.01.227. Epub 2014 Feb 6.
- Individual participant dataSharing planned: Yes. After anonymizing, IPD will be shared after the study is completed.
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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.
Samuel YP Quek, DMD, MPH contact
Gayathri D Subramanian, PhD, DMD principal investigator
Rutgers School of Dental Medicine
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 in people with Acute Pain, 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 6 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: looking for participants now, as of the sponsor's last update on 5 Dec 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 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 Subramanian, PhD, DMD (9739723418, subramga@sdm.rutgers.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak post-operative Pain Score (time frame: up to 4 hours on day of procedure, post-procedure). The study lists 6 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 NCT05335070, which also lists 3 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 5 Dec 2025.