Status:
RECRUITING
Twin Block, Pain Medications and Third Molar Extractions
Lead Sponsor:
Rutgers, The State University of New Jersey
Collaborating Sponsors:
New Jersey Health Foundation
Conditions:
Acute Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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...
Detailed Description
Annually, over 3.5 million predominantly young and healthy individuals undergo outpatient third molar tooth extractions and routinely receive postoperative opioid prescription (Moore, Nahouraii et al....
Eligibility Criteria
Inclusion
- 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
- are older than 18 years of age,
- are healthy,
- have no cognitive/intellectual disability,
- have no past/recent pain or reduced range of motion in their jaw joint/ muscle complex, no trauma or surgery in their jaw region.
- have an electronic device such as a smart phone or a tablet/ computer with internet connection.
- are willing to participate in the study and not be excluded by the following criteria below.
Exclusion
- Any patients, even if satisfying the criteria above, may not take part if they have any of the following:
- 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.
- 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.
- 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.
- Those with long standing pain of the jaw joint or muscles.
- 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.
Key Trial Info
Start Date :
March 11 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2026
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT04880707
Start Date
March 11 2024
End Date
August 1 2026
Last Update
October 7 2025
Active Locations (1)
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1
Rutgers School of Dental Medicine
Newark, New Jersey, United States, 07103