Nerve Block for Reducing Pain After Wisdom Tooth Extraction

Overseen By Samuel YP Quek, DMD, MPH

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Rutgers, The State University of New Jersey

Must not be taking: Opioids, Acetaminophen, Ibuprofen

Disqualifiers: Age over 64, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to reduce pain after wisdom teeth removal. The study focuses on a special nerve block, the Temporo-masseteric Nerve Block, which could ease pain in the first week after surgery. Participants will report their pain levels and any pain medications used during this period. This trial may suit individuals healthy enough for dental surgery under sedation and who can use a smartphone. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group.

Do I need to stop my current medications for this trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you have an allergy to dental local anesthetics or cannot tolerate common pain medications like opioids, acetaminophen, or ibuprofen, you may not be eligible to participate.

What prior data suggests that the Temporo-masseteric Nerve Block is safe for reducing pain after wisdom tooth extraction?

Research has shown that the Temporo-masseteric Nerve Block (TMNB) is safe and effective for easing pain after dental surgery. Studies have found that TMNB quickly relieves jaw pain, and the relief lasts without serious side effects. Although more research is needed, early results suggest that patients tolerate this treatment well. TMNB uses a standard dental anesthetic, which is widely used and known to be safe. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

The Temporo-masseteric Nerve Block (TMNB) is unique because it targets the nerves specifically responsible for pain after wisdom tooth extraction, unlike standard pain management options like oral painkillers or general local anesthetics that work more broadly. Researchers are excited about this treatment because it uses a targeted nerve block with a specific anesthetic, 2% lidocaine with epinephrine, which can potentially provide more precise and effective pain relief right at the source, potentially reducing the need for systemic pain medications. This approach may also minimize side effects and improve recovery time, offering a more efficient pain management solution after dental surgery.

What evidence suggests that the Temporo-masseteric Nerve Block is effective for reducing pain after wisdom tooth extraction?

Studies have shown that the Temporo-masseteric Nerve Block (TMNB), which participants in this trial will receive, effectively reduces jaw pain after wisdom tooth extractions. Research indicates that TMNB provides quick and lasting pain relief and alleviates muscle spasms around the jaw. By targeting specific nerves in the jaw, this nerve block may reduce pain and stiffness. Early evidence supports its potential to ease discomfort from dental procedures, making it a promising option for those undergoing wisdom tooth removal. ^{4 6 7 8 9}

Who Is on the Research Team?

Gayathri D Subramanian, PhD, DMD

Principal Investigator

Rutgers School of Dental Medicine

Are You a Good Fit for This Trial?

This trial is for adults aged 18-64 who need their lower wisdom teeth removed and can consent to the study. They must be healthy enough for sedation, not pregnant, have internet access with a smartphone, and able to take common pain meds like Tylenol or Advil.

Inclusion Criteria

My background or age does not limit my participation.

Not pregnant (as will not qualify to undergo procedure under intravenous sedation as part of routine standard-of-care)

I understand the details of the clinical trial and can give informed consent.

Exclusion Criteria

I have difficulty opening my mouth, with or without pain.

Pregnant

I am unable to understand and give consent for treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Procedure and Immediate Post-Procedure

Participants undergo lower wisdom molar extraction under intravenous sedation and receive the TMNB injection. Pain scores are recorded up to 4 hours post-procedure.

1 day

1 visit (in-person)

Post-operative Monitoring

Participants' pain experience and medication use are monitored daily for one week post-procedure. Adverse effects are also recorded.

1 week

Remote monitoring

Follow-up

Participants return for a post-operative evaluation to assess healing and any adverse effects.

1 day

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Temporo-masseteric Nerve Block

Trial Overview

The study tests if a local anesthetic injection called Temporo-masseteric Nerve Block reduces pain after wisdom tooth removal under sedation. Participants will report their pain levels and medication use over the first week post-surgery.

How Is the Trial Designed?

Group I: Temporo-masseteric Nerve Block (TMNB) Injection with Local Anesthetic Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Rutgers, The State University of New Jersey

Lead Sponsor

Trials

471

Recruited

81,700+

Published Research Related to This Trial

The twin block nerve block effectively targets both the masseteric and anterior deep temporal nerves, providing rapid and lasting relief for chronic masticatory myofascial pain, which is a common nonodontogenic pain condition.

This case series highlights the potential of the twin block as a promising alternative or complement to conventional treatments like physical therapy and medications for managing myofascial pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of the twin block, a peripheral nerve block for the management of chronic masticatory myofascial pain: A case series. Kanti, V., Ananthan, S., Subramanian, G., et al.[2021]

The mandibular nerve block is an effective technique for reducing peri-operative pain and improving visibility during mandibular osteotomy, making it a valuable alternative to general anesthesia for facial surgeries.

Using a neurostimulator to locate the mandibular nerve minimizes complications, such as failure or arterial puncture, and enhances patient comfort when combined with sedation techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Percutaneous mandibular nerve block using neuro-stimulation guiding through the sigmoid indentation in facial surgery]. Espitalier, F., Dubost, AF., Goga, D., et al.[2019]

A study using cadaveric specimens found that a 1 mL injection for a maxillary nerve block effectively covers the nerve, suggesting it may be a safer option compared to a 5 mL injection, which often leads to drug spread outside the targeted area.

The research quantified the optimal angles and depths for needle insertion, providing valuable insights that could improve the reliability and efficacy of maxillary nerve blocks in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasound-guided maxillary nerve block: an anatomical study using the suprazygomatic approach. Echaniz, G., Chan, V., Maynes, JT., et al.[2021]

A continuous bilateral mandibular nerve block (MNB) using a suprazygomatic approach effectively managed refractory trismus and pain in a patient with tetraplegia, providing analgesia for up to 72 hours.

This technique allowed for significant pain relief and improved mouth opening, enabling the introduction of kinesitherapy while minimizing the need for opioid analgesics, demonstrating its safety and efficacy in challenging clinical situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Suprazygomatic Access for Continuous Bilateral Mandibular Nerve Block for Pain and Trismus Relief in the Tetraplegic Patient. Dziadzko, MA., Heritier, F.[2017]

The twin block injection is effective in reducing pain from both the temporomandibular joint (TMJ) and associated muscle pain, as demonstrated in a case study of a 19-year-old man with acute anterior disc displacement and myalgia.

After receiving the twin block injection, the patient experienced significant pain relief in the TMJ and surrounding muscles, indicating its potential as a treatment for temporomandibular disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The twin block injection: an adjunctive clinical aid for the management of acute arthrogenous temporomandibular joint dysfunction. Ananthan, S., Subramanian, G., Patel, T., et al.[2021]

A study involving 100 patients demonstrated that the posterior superior alveolar nerve block (PSANB) alone is effective for pain control during maxillary third molar extractions, reducing the need for additional palatal injections.

The depth of anesthesia achieved with PSANB was sufficient for most cases, with effective coverage extending to the first molar, indicating that this method can simplify the procedure and improve patient comfort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Posterior superior alveolar nerve block alone in the extraction of upper third molars: a prospective clinical study. Tummalapalli, S., M, RS., Inturi, NMR., et al.[2023]

The twin block nerve block technique is effective for the long-term management of masticatory myofascial pain, showing similar pain reduction to trigger point injections over a 6-month period in a study of 40 patients.

Both treatment methods resulted in significant pain reduction from baseline (around 6.5) to follow-up (around 1.85), but there were no statistically significant differences in pain intensity between the two groups, indicating that the twin block is a viable alternative to trigger point injections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of the twin block compared with trigger point injections in patients with masticatory myofascial pain: a pilot study. Ananthan, S., Kanti, V., Zagury, JG., et al.[2022]

Continuous mandibular nerve block using a catheter to deliver 0.25% bupivacaine provided excellent pain relief for two patients with mandible fractures, eliminating the need for additional analgesics post-surgery.

This method demonstrated no side effects, suggesting it could be a safe and effective alternative for managing pain in similar surgical procedures or conditions affecting the mandibular region.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous mandibular nerve block for pain relief. A report of two cases. Singh, B., Bhardwaj, V.[2022]

Mandibular nerve block using 0.25% bupivacaine provided effective pain relief for a patient undergoing surgery for a mandibular fracture, with Visual Analog Scale (VAS) scores remaining below 4 throughout the observation period.

The procedure demonstrated a favorable safety profile, with the only side effect being temporary numbness of the lower jaw, which resolved after stopping the local anesthetic administration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Post operative pain relief through intermittent mandibular nerve block. Sawhney, C., Agrawal, P., Soni, KD.[2021]

Citations

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Temporo-masseteric Nerve Block in post-wisdom tooth ...

The TMNB has shown early promise in providing sustained pain and jaw muscle spasm relief post-dental surgical procedures and in alleviating chronic jaw muscle ...

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trialx.com

trialx.com/clinical-trials/listings/268732/reducing-pain-from-wisdom-molar-extractions/

Reducing Pain From Wisdom Molar Extractions

The investigators found that the TMNB relieved jaw pain stemming from these muscles, in a quick and sustained manner, even in patients whose ...

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11922512/

The Temporo-Masseteric Nerve Block (TMNB) for ...

Early data has also emerged that support the analgesic potential of the TMNB in alleviating pain and trismus secondary to dental extractions.

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withpower.com

withpower.com/trial/phase-2-acute-pain-4-2022-31c34

Nerve Block for Reducing Pain After Wisdom Tooth Extraction

Trial Overview The study tests if a local anesthetic injection called Temporo-masseteric Nerve Block reduces pain after wisdom tooth removal under sedation.

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pmc.ncbi.nlm.nih.gov/articles/PMC11810664/

Safety, efficacy, and mechanism of action of the temporo- ...

The objective of the study was to assess the utility and safety of Temporo-masseteric Nerve Block (TMNB), and to explore the mechanism for its apparent ...

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reporter.nih.gov

reporter.nih.gov/project-details/11033310

RePORT RePORTER

The TMNB has shown early promise in providing sustained pain and jaw muscle spasm relief post-dental surgical procedures and in alleviating chronic jaw muscle ...

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reporter.nih.gov

reporter.nih.gov/search/10EECF0E478CC1DE7598B8961CAA4A01A2FFCEB861BF/project-details/11033310

Project Details - NIH RePORTER

This innovative proposal explores the ability of a novel local anesthetic injection (the temporo-masseteric nerve block or 'TMNB') developed by Dr. Subramanian ...

8.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07094542

Jaw Muscle Pain Post Wisdom Molar Surgery

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 ...

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files.jofph.com/files/article/20240612-320/pdf/OFPH20240111001.pdf

Safety, efficacy, and mechanism of action of the temporo- ...

In conclusion, the TMNB injection is efficacious and safe. Further studies are warranted to warrant its effectiveness. Keywords. Temporo- ...