48 Participants Needed

Twin Block Anesthesia for Acute Pain

GS
BK
Overseen ByBrahmleen Kaur, DMD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Rutgers, The State University of New Jersey
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to manage pain after wisdom tooth removal without opioids. Researchers are testing the "Twin Block" injection, which numbs the jaw muscles that often cause pain after the procedure. Participants will receive either this anesthetic or a placebo to determine its effectiveness in reducing pain and the need for opioids. The trial seeks healthy individuals experiencing significant jaw pain after the removal of at least one impacted wisdom tooth. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to innovative pain management solutions.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you have used opioid pain medications in the past or are on long-term anti-inflammatory pain medication.

What prior data suggests that the Twin Block dental anesthetic injection is safe for managing acute pain?

Research shows that local anesthetic nerve blocks, such as the Twin Block, are generally safe and well-tolerated. Previous studies have reported few complications with these anesthetics. Although there is a small risk of nerve damage, it remains rare. The Twin Block uses a common dental anesthetic, known to be safe for most people, and most individuals do not experience serious side effects. This makes the Twin Block a promising option for managing pain after wisdom teeth removal, potentially reducing the need for opioids without significant risk.12345

Why do researchers think this study treatment might be promising?

Researchers are excited about the Twin Block Anesthesia because it could offer a new way to manage acute pain following dental procedures, like wisdom tooth extractions. Most standard treatments rely on oral pain medications, which can take time to work and may have systemic side effects. Unlike these options, the Twin Block approach directly targets the nerve using a local anesthetic, 2% lidocaine with 1:100,000 epinephrine, providing potentially faster and more localized pain relief. This method could mean quicker pain management with fewer side effects, making recovery from dental surgery more comfortable.

What evidence suggests that the Twin Block dental anesthetic injection is effective for reducing pain after wisdom tooth removal?

Research has shown that the Twin Block injection effectively reduces pain in the jaw muscles. In earlier studies, this method provided quick and long-lasting relief for pain in the jaw and nearby muscles. Some reports indicate it also alleviates pain, swelling, and muscle stiffness after wisdom tooth removal. In this trial, participants will be randomized to receive either the Twin Block with a local anesthetic or the Twin Block with sterile normal saline. The Twin Block numbs the nerves controlling the jaw muscles, reducing pain in these areas. This suggests that using the Twin Block could decrease the need for opioids after dental surgery, offering relief without the risk of addiction.14678

Who Is on the Research Team?

GS

Gayathri Subramanian, PhD, DMD

Principal Investigator

Rutgers School of Dental Medicine, Newark NJ

Are You a Good Fit for This Trial?

This trial is for healthy adults over 18 needing at least one lower wisdom tooth removed, who can use a smart device with internet. They shouldn't have jaw pain or limited motion history, be pregnant, prisoners, children, or intellectually disabled. Allergies to local anesthetics or common pain relievers like Tylenol and Advil are disqualifiers.

Inclusion Criteria

I have not had jaw pain, limited movement, trauma, or surgery recently.
I need at least one lower wisdom tooth removed and it's partially or fully stuck.
Patients with no cognitive/intellectual disability
See 4 more

Exclusion Criteria

I am allergic to or cannot tolerate dental anesthetics, opioids, Tylenol, or Advil.
I have an infection in my wisdom teeth that will be removed on the day of my procedure.
I have used opioid painkillers or have been on long-term anti-inflammatory pain medication.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 day
1 visit (in-person)

Treatment

Participants undergo third molar extraction under intravenous sedation and receive either the Twin block or placebo injection based on randomization

1 day
1 visit (in-person)

Follow-up

Participants are monitored for pain levels and opioid consumption over a 7-day period

1 week
Daily contact for pain and medication tracking

What Are the Treatments Tested in This Trial?

Interventions

  • Twin Block local anesthetic nerve block using standard dental anesthetic
  • Twin block with placebo
Trial Overview The study tests the Twin Block dental anesthetic injection versus a placebo in managing post-wisdom tooth removal pain. It aims to see if this technique reduces both the intensity of jaw-clencher muscle pain and the need for opioid medication after surgery.
How Is the Trial Designed?
2Treatment groups
Active Control
Placebo Group
Group I: Twin Block with Local AnestheticActive Control1 Intervention
Group II: Twin Block with sterile normal salinePlacebo Group1 Intervention

Twin Block local anesthetic nerve block using standard dental anesthetic is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Twin Block local anesthetic nerve block for:
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Approved in European Union as Twin Block local anesthetic nerve block for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Rutgers, The State University of New Jersey

Lead Sponsor

Trials
471
Recruited
81,700+

New Jersey Health Foundation

Collaborator

New Jersey Health Foundation

Collaborator

Trials
3
Recruited
220+

Published Research Related to This Trial

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.
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]
Dental nerve blocks are an effective and cost-efficient method for managing pain during oral procedures, offering quick relief and complementing other forms of anesthesia.
The article provides guidance on how to properly administer these nerve blocks, along with important indications and precautions to ensure patient safety.
Administering dental nerve blocks.Reuss-Lamky, H.[2007]
In a study of 110 asymptomatic subjects, the position of the patient (upright vs. supine) during inferior alveolar nerve block (IANB) administration did not significantly affect the success of pulpal anesthesia in molars and anterior teeth.
The supine position did show improved success rates for pulpal anesthesia in premolars, but overall, neither position provided complete pulpal anesthesia, indicating that other factors may influence the effectiveness of IANB.
Anesthetic Efficacy of Supine and Upright Positions for the Inferior Alveolar Nerve Block: A Prospective, Randomized Study.Crowley, C., Drum, M., Reader, A., et al.[2018]

Citations

Twin Block Anesthesia for Acute PainThe twin block injection is effective in reducing pain from both the temporomandibular joint (TMJ) and associated muscle pain, as demonstrated in a case study ...
review twin-mix injection reduces postoperative ...In conclusion, the use of twin-mix is highly beneficial for pain relief, facial swelling and trismus following mandibular third molar surgical removal. Previous ...
The Effect of 2 Injection Speeds on Local Anesthetic ...We concluded that the 2 injection speeds tested did not affect the volunteers' pain perception during inferior alveolar nerve blocks. Key Words: Inferior ...
Efficacy of the twin block, a peripheral nerve ...Peripheral/regional nerve blocks have shown to be effective in managing myogenous pain conditions. The twin block is a nerve block that blocks both the ...
Use of injection techniques in orofacial pain emergenciesThe temporo-masseteric nerve block is useful for reducing a painful non-reducing disc as well (22). The whole carpule (1.8 mL) of 2% Lidocaine ...
Adverse effects following dental local anesthesiaThis study included 78 articles. Ocular and neurological adverse effects, allergies, hematomas, needle breakage, tissue necrosis, blanching, jaw ankylosis, ...
Recent advances in dental local anaesthesiaThe evidence for these devices and techniques is mixed, with some trials reporting reduced pain or anxiety and increased speed of onset or anaesthesia success ...
Proposed Mechanism of Action for Twin Mix Anaesthesia ...Twin mix anaesthesia has its advantages in shortening the latency and prolonging the duration of the soft tissue anaesthesia, along with improving the quality ...
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