Acute PainPhase 2NCT04880707
Twin Block, Pain Medications and Third Molar Extractions
A Phase 2 study testing Twin block local anesthetic nerve block using standard dental anesthetic in people with Acute Pain, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Pain
- What is being tested?
- Twin block local anesthetic nerve block using standard dental anesthetic
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Mar 2024to 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients requiring 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 older than 18 years of age,
- 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
- Any patients, even if satisfying the criteria above, may not take part if they have any of the following:
- 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.
- In addition, those who have had opioid pain medication/s in the past 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 pain of the jaw joint or muscles.
- Finally, those patients who are allergic to/unable to tolerate either the dental local anesthetic or its components, opioids, acetaminophen ('Tylenol') or ibuprofen ('Motrin' or 'Advil') 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, 1 recruiting
- Recruiting
Rutgers School of Dental Medicine
Newark, New Jersey, 07103
Gayathri Subramanian, PhD, DMD, 973-972-3418, subramga@sdm.rutgers.edu
About this study
Official title: Myogenous Face Pain Following Third Molar Extractions Under Intravenous Sedation
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 Twin Block dental anesthetic injection. The Twin block 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 Twin block 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. However, what is not known is- how often do patients who have their wisdom teeth removed under sedation, end up in significant pain from taut and tender jaw-clencher muscles? Will using the twin block effectively reduce pain in such patients? In this pilot study, the investigators will examine wisdom molar extraction patients one day after their procedure. Those with significant pain (pain rated ≥ 5 on a 0-10 scale) in their jaw-clencher muscles, will get either the Twin block injection or a placebo. The investigators will track both 1) pain before and after the injection, and 2) pain medication usage over a 7-day period to see if both pain and opioid dosage come down with the Twin block. This study can support a simple, safe and inexpensive means to reduce pain after a common procedure.
Read the detailed description
Annually, over 3.5 million predominantly young and healthy individuals undergo outpatient third molar tooth extractions and routinely receive postoperative opioid prescription (Moore, Nahouraii et al. 2006). This procedure is among the most prevalent instances of opioid prescriptions to adolescents and is the subject of a national debate, given the CDC's mandate for minimizing the number and duration of opioid prescriptions (Volkow, McLellan et al. 2011, Dowell, Haegerich et al. 2016, Moore, Dionne et al. 2016). Targeting such a prevalent practice by supplementing postoperative analgesia with non-opioid options as well as optimizing and tracking opioid usage will significantly reduce prescription opioid use/misuse. The Twin Block is a local anesthetic nerve block that eases muscle pain emanating from the jaw muscles and has been anecdotally shown to be effective in relieving post-operative pain in patients who developed muscle pain following third molar extractions. However, the incidence of acute muscle pain following third molar extractions is not well established. Accordingly, the aims of this study are two-fold:
- Objectives This study has 2 objectives: 1) To estimate the incidence of acute muscle pain involving the temporalis and masseter muscles (the jaw closer muscles that are commonly implicated in resulting in jaw muscle pain), following third molar extractions and 2) Conduct a double-blind prospective study to compare the efficacy of Twin Block in relieving postextraction pain in those patients determined to experience muscle pain following the procedure B. Hypotheses / Research Question(s) Hypothesis 1: The incidence of post-third molar extraction muscle pain is at least 40% Hypothesis 2: Twin block reduces post-extraction muscle pain by 50% 1.2 Research Significance The twin block is a simple and effective local anesthetic nerve block for 'numbing' the innervation to the masseter and temporalis muscles, two key jaw clencher muscles, with emerging data corroborating efficacy in the diagnosis and management of both acute and chronic myogenous orofacial pain (Quek, Young et al. 2014, Ananthan et al. 2017). 1.3 Research Design and Methods The study is designed as a prospective evaluation of patients undergoing third molar extractions under intravenous sedation to identify those developing post-extraction muscle pain on the day following the procedure. Subsequently, such patients will be prospectively randomized to receive the Twin block to deliver either the dental local anesthetic or saline as a placebo. Post-injection muscle pain will be evaluated 15 minutes following the administration of the injection. All patients will be provided similar directions and prescriptions for pain management. All patients will be contacted to document/report their daily pain medications and queried one week after the extraction/s for their overall pain experience and any adverse effects from the injection.
- Conditions
- Acute Pain
- Being tested
- Twin block local anesthetic nerve block using standard dental anesthetic, Twin block with placebo
- Keywords
- 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.
Twin block local anesthetic nerve block using standard dental anestheticDrug
2% lidocaine with 1:100,000 epinephrine is the standard dental local anesthetic in universal use. This drug will be administered as the Twin block local anesthetic nerve block targeting the branches of the mandibular nerve supplying the temporalis and masseter muscles.
Twin block with placeboOther
Instead of the standard dental anesthetic, sterile normal saline will be delivered using the Twin block injection
| Study group | Role | What they receive |
|---|---|---|
| Twin Block with Local Anesthetic | Active comparator | Following lower third molar extraction under intravenous sedation, the patient randomized to this arm with receive the Twin block local anesthetic nerve block using the standard dental local anesthetic, i.e,. 2% lidocaine with 1:100,000 epinephrine, on the day after extraction, if the patient has pain greater than or equal to 5 on 10 in their jaw-closer muscles (Numerical Pain rating scale). Receives: Drug: Twin block local anesthetic nerve block using standard dental anesthetic |
| Twin Block with sterile normal saline | Placebo comparator | Following lower third molar extraction under intravenous sedation, the patient randomized to this arm with receive the Twin block using sterile normal saline, on the day after extraction, if the patient has pain greater than or equal to 5 on 10 in their jaw-closer muscles (Numerical Pain rating scale). Receives: Other: Twin block with placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-injection muscle pain
NRS pain scores before and 15 min after Twin block administration on day after procedure
Measured: 15 minutes
Mean NRS pain score
Means NRS pain score by Day, comparing placebo and Twin block groups
Measured: one week
Total prescription opioid consumption
Comparison of total prescription opioid consumption (mg) between placebo and Twin block groups
Measured: one week
Secondary outcomes (2)
Passive mouth opening
Comparison of passive mouth opening before and 15 min after Twin block administration on day after procedure
Measured: 15 min
Passive mouth opening
Comparison of baseline and end-of-study passive mouth opening between Twin block and placebo groups
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2021
- Study start11 Mar 2024
- Primary completionAug 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Triple blind, randomized prospective pilot study comparing post wisdom molar extraction pain comparing placebo or Twin block local anesthetic nerve block injection
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- New Jersey Health Foundation
- Responsible party
- Principal investigator, Gayathri Subramanian, Rutgers, The State University of New Jersey
- Investigators
- Gayathri Subramanian, PhD, DMD, Principal investigator, Rutgers School of Dental Medicine, Newark NJ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04880707
- Sponsor's protocol ID
- Pro2020002007
- Status last verified
- Jun 2026
- First submitted
- 5 May 2021
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 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 24703404Quek 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 28990015
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myogenous Face Pain Following Third Molar Extractions Under Intravenous Sedation
- ClinicalTrials.gov ID
- NCT04880707
- Acronym / sponsor ID
- Pro2020002007
- Conditions
- Acute Pain
- Keywords
- Twin block, Prescription opioids, Acute post-extraction pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- New Jersey Health Foundation
- Study start
- 11 Mar 2024 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 11 May 2021 (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.
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 Twin Block dental anesthetic injection. The Twin block 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 Twin block 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. However, what is not known is- how often do patients who have their wisdom teeth removed under sedation, end up in significant pain from taut and tender jaw-clencher muscles? Will using the twin block effectively reduce pain in such patients? In this pilot study, the investigators will examine wisdom molar extraction patients one day after their procedure. Those with significant pain (pain rated ≥ 5 on a 0-10 scale) in their jaw-clencher muscles, will get either the Twin block injection or a placebo. The investigators will track both 1) pain before and after the injection, and 2) pain medication usage over a 7-day period to see if both pain and opioid dosage come down with the Twin block. This study can support a simple, safe and inexpensive means to reduce pain after a common procedure.
Detailed description
Annually, over 3.5 million predominantly young and healthy individuals undergo outpatient third molar tooth extractions and routinely receive postoperative opioid prescription (Moore, Nahouraii et al. 2006). This procedure is among the most prevalent instances of opioid prescriptions to adolescents and is the subject of a national debate, given the CDC's mandate for minimizing the number and duration of opioid prescriptions (Volkow, McLellan et al. 2011, Dowell, Haegerich et al. 2016, Moore, Dionne et al. 2016). Targeting such a prevalent practice by supplementing postoperative analgesia with non-opioid options as well as optimizing and tracking opioid usage will significantly reduce prescription opioid use/misuse. The Twin Block is a local anesthetic nerve block that eases muscle pain emanating from the jaw muscles and has been anecdotally shown to be effective in relieving post-operative pain in patients who developed muscle pain following third molar extractions. However, the incidence of acute muscle pain following third molar extractions is not well established. Accordingly, the aims of this study are two-fold:
- Objectives This study has 2 objectives: 1) To estimate the incidence of acute muscle pain involving the temporalis and masseter muscles (the jaw closer muscles that are commonly implicated in resulting in jaw muscle pain), following third molar extractions and 2) Conduct a double-blind prospective study to compare the efficacy of Twin Block in relieving postextraction pain in those patients determined to experience muscle pain following the procedure B. Hypotheses / Research Question(s) Hypothesis 1: The incidence of post-third molar extraction muscle pain is at least 40% Hypothesis 2: Twin block reduces post-extraction muscle pain by 50% 1.2 Research Significance The twin block is a simple and effective local anesthetic nerve block for 'numbing' the innervation to the masseter and temporalis muscles, two key jaw clencher muscles, with emerging data corroborating efficacy in the diagnosis and management of both acute and chronic myogenous orofacial pain (Quek, Young et al. 2014, Ananthan et al. 2017). 1.3 Research Design and Methods The study is designed as a prospective evaluation of patients undergoing third molar extractions under intravenous sedation to identify those developing post-extraction muscle pain on the day following the procedure. Subsequently, such patients will be prospectively randomized to receive the Twin block to deliver either the dental local anesthetic or saline as a placebo. Post-injection muscle pain will be evaluated 15 minutes following the administration of the injection. All patients will be provided similar directions and prescriptions for pain management. All patients will be contacted to document/report their daily pain medications and queried one week after the extraction/s for their overall pain experience and any adverse effects from the injection.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Triple blind, randomized prospective pilot study comparing post wisdom molar extraction pain comparing placebo or Twin block local anesthetic nerve block injection
| Arm | Type | Receives |
|---|---|---|
| Twin Block with Local Anesthetic | Active comparator | Drug: Twin block local anesthetic nerve block using standard dental anestheticFollowing lower third molar extraction under intravenous sedation, the patient randomized to this arm with receive the Twin block local anesthetic nerve block using the standard dental local anesthetic, i.e,. 2% lidocaine with 1:100,000 epinephrine, on the day after extraction, if the patient has pain greater than or equal to 5 on 10 in their jaw-closer muscles (Numerical Pain rating scale). |
| Twin Block with sterile normal saline | Placebo comparator | Other: Twin block with placeboFollowing lower third molar extraction under intravenous sedation, the patient randomized to this arm with receive the Twin block using sterile normal saline, on the day after extraction, if the patient has pain greater than or equal to 5 on 10 in their jaw-closer muscles (Numerical Pain rating scale). |
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 requiring 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
Key exclusion criteria (6 listed)
- Any patients, even if satisfying the criteria above, may not take part if they have any of the following:
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 |
|---|---|---|
| Twin block local anesthetic nerve block using standard dental anesthetic2% lidocaine with 1:100,000 epinephrine is the standard dental local anesthetic in universal use. This drug will be administered as the Twin block local anesthetic nerve block targeting the branches of the mandibular nerve supplying the temporalis and masseter muscles. | Drug | Twin Block with Local Anesthetic |
| Twin block with placeboInstead of the standard dental anesthetic, sterile normal saline will be delivered using the Twin block injection | Other | Twin Block with sterile normal saline |
Primary outcome
Post-injection muscle pain
Time frame: 15 minutes
NRS pain scores before and 15 min after Twin block administration on day after procedure
Mean NRS pain score
Time frame: one week
Means NRS pain score by Day, comparing placebo and Twin block groups
Total prescription opioid consumption
Time frame: one week
Comparison of total prescription opioid consumption (mg) between placebo and Twin block groups
2 secondary outcomes
Passive mouth opening
Time frame: 15 min
Passive mouth opening
Time frame: one week
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 22 Jun 2026.
- 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.
- Results publication: 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.
- Results publication: 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.
- Individual participant dataSharing planned: Yes. After anonymizing, IPD will be shared after the study is completed.
Related trials for Acute Pain
Not yet recruiting
Pilot Study: Clinical Trial of Ultrasound Guiding Pharmacopuncture Therapy for Acute Low Back Pain
Low Back Pain (LBP)
Recruiting
CT Stress Myocardial Perfusion, Fractional Flow Reserve and Angiography in Patients With Stable Chest Pain Syndromes
Coronary Artery Disease, Chest Syndrome
Not yet recruitingPhase 2
Investigating the Analgesic Potential of (2R,6R)-HNK in Acute Pain in Healthy Volunteers
Healthy Volunteers
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
Acute Coronary Syndromes, STEMI
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.
Gayathri Subramanian, PhD, DMD principal investigator
Rutgers School of Dental Medicine, Newark NJ
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 Twin block local anesthetic nerve block using standard dental anesthetic 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 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: looking for participants now, as of the sponsor's last update on 22 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. 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 Gayathri Subramanian, PhD, DMD (973 972 3418, subramga@sdm.rutgers.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-injection muscle pain (time frame: 15 minutes). The study lists 3 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 NCT04880707, 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 22 Jun 2026.