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NCT07094542
Jaw Muscle Pain Post Wisdom Molar Surgery
Conditions: Post Operative Pain, Impacted Third Molar Tooth, Muscle Pain
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 80
Sponsor: Rutgers, The State University of New Jersey
Location: Rutgers School of Dental Medicine Newark New Jersey
Summary
The proposed design is a triple-blind, placebo-controlled randomized prospective phase II trial to assess the feasibility of employing the Temporo-masseteric Nerve Block (TMNB) injection to decrease jaw muscle pain, overall pain, improve mouth opening and minimize pain medication consumption. 80 participants undergoing lower third molar removal under sedation will be enrolled. Those who develop significant jaw muscle pain on the following day will be randomized to receive either the TMNB injection or a placebo. Daily ecological momentary assessments (EMAs) will be collected reflecting elements of patient experience for all participants. On Day 8, participants return for an end-of-study evaluation and return their unused pain medications. Up to 40 participants who are randomized to receive TMNB/placebo will be recruited to participate in a qualitative interview regarding their experience.
Eligibility Criteria
Inclusion Criteria:
All patients recommended 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 18 years or older,
* 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 Criteria:
An individual who meets any of the following criteria will be excluded from participation in this study:
* 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.
* Those who have had opioid pain medication/s in the past 3 months 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 painful limitation of movement of the jaw joint or muscles.
* Those patients who are allergic to/unable to tolerate either the dental local anesthetic or its components, opioids, acetaminophen or ibuprofen also may not take part in the study
Source: ClinicalTrials.gov (NCT07094542). StuddyBuddy aggregates publicly available trial information.