Twin Block, Pain Medications and Third Molar Extractions

• Status: Not yet recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Each year, over 3.5 million, mostly, healthy young adults, have their third molar teeth ('wisdom teeth') removed under sedation and are often given opioid prescriptions for managing their pain. Wisdom molar removal is one of the most common reasons for opioid prescriptions to be given to adolescents. There is a national thrust to reduce both the dose and the duration of such opioid prescriptions because even short-term opioid exposures increase risk for narcotic addiction and misuse. Non-opioid options to manage pain will still allow for sufficient pain control without risking addiction, and hence, a fundamental component of our response to combat the current national opioid crisis.

The investigators are going to study a promising option- the Twin Block dental anesthetic injection. The Twin block involves injecting the standard dental numbing medication in a way that 'numbs' the 'jaw-clencher' muscles on the side of the face. The investigators found that the Twin block relieved jaw pain stemming from these muscles, in a quick and sustained manner, even in patients whose pain following wisdom tooth removal primarily came from 'taut' and tender jaw-clencher muscles. However, what is not known is- how often do patients who have their wisdom teeth removed under sedation, end up in significant pain from taut and tender jaw-clencher muscles? Will using the twin block effectively reduce pain in such patients? In this pilot study, the investigators will examine wisdom molar extraction patients one day after their procedure. Those with significant pain (pain rated ≥ 5 on a 0-10 scale) in their jaw-clencher muscles, will get either the Twin block injection or a placebo. The investigators will track both 1) pain before and after the injection, and 2) pain medication usage over a 7-day period to see if both pain and opioid dosage come down with the Twin block. This study can support a simple, safe and inexpensive means to reduce pain after a common procedure.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rutgers, The State University of New Jersey
• Collaborator: New Jersey Health Foundation
• Treatments: Anesthetics; Anesthetics, Local

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.