Using Twin Block anesthesia to manage pain after wisdom tooth removal

Myogenous Face Pain Following Third Molar Extractions Under Intravenous Sedation

This study is testing if a new dental anesthesia technique called Twin Block can help reduce pain after wisdom tooth removal compared to a placebo.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 48 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Rutgers, The State University of New Jersey (other)
• Locations: 1 site (Newark, New Jersey)
• Trial ID: NCT04880707 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness of the Twin Block dental anesthetic technique in managing acute pain following third molar extractions. It aims to estimate the incidence of muscle pain in the jaw after these procedures and compare the efficacy of the Twin Block against a placebo. The study is designed as a double-blind, prospective trial, ensuring that neither the participants nor the researchers know who receives the active treatment or the placebo. This approach seeks to provide a non-opioid alternative for pain management, addressing concerns about opioid prescriptions in young adults.

Who should consider this trial

Good fit: Ideal candidates are healthy adults over 18 years old requiring the extraction of impacted lower wisdom teeth.

Not a fit: Patients with cognitive disabilities, recent jaw trauma, or those who are pregnant will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a safer, non-opioid method for managing pain after wisdom tooth extractions, reducing the risk of opioid addiction.

How similar studies have performed: Other studies have explored non-opioid pain management techniques, but the Twin Block approach is relatively novel in this context.

Eligibility criteria

Inclusion Criteria:

* 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

  1. are older than 18 years of age,
  2. are healthy,
  3. have no cognitive/intellectual disability,
  4. have no past/recent pain or reduced range of motion in their jaw joint/ muscle complex, no trauma or surgery in their jaw region.
  5. have an electronic device such as a smart phone or a tablet/ computer with internet connection.
  6. are willing to participate in the study and not be excluded by the following criteria below.

Exclusion Criteria:

* Any patients, even if satisfying the criteria above, may not take part if they have any of the following:

  1. 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.
  2. 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.
  3. 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.
  4. Those with long standing pain of the jaw joint or muscles.
  5. 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.

Where this trial is running

Newark, New Jersey

• Rutgers School of Dental Medicine — Newark, New Jersey, United States (RECRUITING)

Study contacts

• Principal investigator: Gayathri Subramanian, PhD, DMD — Rutgers School of Dental Medicine, Newark NJ
• Study coordinator: Gayathri Subramanian, PhD, DMD

Conditions: Acute Pain, Twin block, Prescription opioids, Acute post-extraction pain