Health Trials

About this trial

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

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Temporo-masseteric Nerve Block Injection
  • Oral Pain Medications only

Treatment groups

80 Participants
are divided into 3 treatment groups

Locations

1
Rutgers School of Dental Medicine07103, NewarkNew Jersey, United States

Sponsors and collaborators

Rutgers, The State University of New Jersey

Lead sponsor

National Institute of Dental and Craniofacial Research (NIDCR)

Collaborator

Source ClinicalTrials.gov