Temporo-masseteric Nerve Block for Postoperative Pain
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines the effectiveness of a Temporo-masseteric Nerve Block (TMNB) injection in reducing jaw pain after wisdom tooth removal. The study will assess whether this injection alleviates pain, improves mouth movement, and reduces the need for painkillers. Participants will receive either the actual TMNB injection or a placebo (a harmless substance resembling the real treatment) to compare results. Individuals scheduled for lower wisdom tooth extraction under sedation, who anticipate jaw pain the following day, may be suitable candidates for this trial. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.
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've used opioid pain medications in the past 3 months or are on long-term anti-inflammatory pain medication.
What prior data suggests that the Temporo-masseteric Nerve Block injection is safe for reducing jaw muscle pain?
A previous study showed that the Temporo-masseteric Nerve Block (TMNB) injection relieves pain and aids mouth movement. Research indicates that TMNB is generally well-tolerated, though some side effects can occur. These include pain at the injection site, swelling, or temporary facial nerve weakness. Such effects are usually mild and resolve on their own. Since this treatment uses a common dental anesthetic, like lidocaine, already approved for other uses, the safety profile is well understood. Overall, TMNB appears safe for most people, but it is important to consider these potential side effects.12345
Why are researchers excited about this trial's treatment?
Researchers are excited about the Temporo-masseteric Nerve Block (TMNB) for postoperative pain management because it offers a targeted approach to pain relief right at the source, unlike standard options such as oral pain medications. Most pain relief after wisdom tooth removal involves systemic drugs like ibuprofen and acetaminophen, which circulate throughout the body and can have side effects. TMNB is delivered directly to the nerves affecting the jaw muscles, potentially providing faster and more localized pain relief. Additionally, the use of dental local anesthetic like 2% lidocaine with epinephrine in TMNB could offer a more effective pain block compared to traditional systemic painkillers.
What evidence suggests that the Temporo-masseteric Nerve Block injection is effective for reducing jaw muscle pain?
In this trial, participants will receive different treatments to manage postoperative pain after wisdom tooth removal. Research has shown that Temporo-masseteric Nerve Block (TMNB) injections can greatly reduce jaw pain. In one study, patients reported a 70% drop in pain levels after receiving a TMNB injection. This treatment also alleviates trismus, a condition where opening the mouth is difficult. TMNB works by blocking pain signals in the jaw, providing relief after wisdom tooth removal. Previous studies suggest that this treatment is generally safe and effective. Participants in this trial may receive a TMNB with either a dental local anesthetic or a placebo, while others will follow a standard pain management regimen with ibuprofen and acetaminophen.14678
Are You a Good Fit for This Trial?
This trial is for adults over 18 who need at least one lower wisdom tooth removed and are in good health with no cognitive disabilities, jaw pain, reduced motion in the jaw, or past trauma/surgery in that area. Participants must have a smart device with internet to record their experience.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo lower third molar removal under sedation and are assessed for jaw muscle pain. Those with significant pain receive either TMNB injection or placebo.
Follow-up
Participants are monitored for pain reduction and mouth opening ability through daily remote surveys and an in-person assessment on Day 8.
Qualitative Interview
Participants randomized to TMNB/placebo may participate in a qualitative interview regarding their experience.
What Are the Treatments Tested in This Trial?
Interventions
- Temporo-masseteric Nerve Block Injection
Find a Clinic Near You
Who Is Running the Clinical Trial?
Rutgers, The State University of New Jersey
Lead Sponsor
National Institute of Dental and Craniofacial Research (NIDCR)
Collaborator