Reducing pain from wisdom tooth extractions
Non-randomized Prospective Pilot Study on Effect of Temporo-masseteric Nerve Block (TMNB) on Pain Reduction Following Wisdom Molar Extractions
This study is testing a new pain relief method for people getting their lower wisdom teeth removed to see if it can help reduce the need for opioid painkillers.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 64 Years |
| Sex | All |
| Sponsor | Rutgers, The State University of New Jersey Academic / other |
| Locations | 1 site (Newark, New Jersey) |
| Trial ID | NCT05335070 on ClinicalTrials.gov |
What this trial studies
This pilot study evaluates the effectiveness of the Temporo-masseteric Nerve Block (TMNB) as a local anesthetic to alleviate pain in individuals undergoing lower wisdom tooth extractions under intravenous sedation. The study aims to reduce reliance on opioid prescriptions for pain management, addressing the national opioid crisis. Participants will receive the TMNB injection and report their pain experiences and medication use during the first week post-surgery, with a follow-up visit on Day 8 to assess outcomes.
Who should consider this trial
Good fit: Ideal candidates are healthy adults aged 18 to 64 who are undergoing lower wisdom tooth extractions and can provide informed consent.
Not a fit: Patients over 64 years old, pregnant individuals, or those with systemic conditions that increase risk during sedation will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce post-operative pain and the need for opioid medications in patients undergoing wisdom tooth extractions.
How similar studies have performed: While the use of nerve blocks in dental procedures is established, this specific approach with the TMNB is novel and has not been extensively tested in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where this trial is running
Newark, New Jersey
- The University Hospital- Dental Clinic — Newark, New Jersey, United States (Recruiting)
Study contacts
- Principal investigator: Gayathri D Subramanian, PhD, DMD — Rutgers School of Dental Medicine
- Study coordinator: Gayathri Subramanian, PhD, DMD
- Email: subramga@sdm.rutgers.edu
- Phone: 9739723418
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.