Not Yet RecruitingPhase 2

Jaw Muscle Pain Post Wisdom Molar Surgery

United States80 participantsStarted 2026-09

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 anes…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial is testing injections called TMNB to reduce jaw muscle pain after wisdom tooth removal — can you explain what these injections actually are and how they work differently from the standard pain management you'd normally prescribe after my surgery?
2Since this is a Phase 2 trial, what does that mean for how much is already known about whether TMNB injections are safe and effective, and what unknowns should I be aware of before considering something like this?
3The trial isn't recruiting yet — if I'm scheduled for wisdom tooth removal soon, would my timing even work with when this study might open, or would I need to plan around it?
4The main thing being measured is jaw muscle pain on palpation after the injections — does that kind of pain relief align with what I'd actually experience as bothersome after my surgery, or is there a broader type of pain or recovery concern I should be thinking about?
5Would standard post-surgical pain management after wisdom tooth removal already address the kind of muscle pain this trial is studying, and is there a reason you'd recommend considering a trial like this over the usual approach?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Jaw Muscle Pain Reduction on palpation post-TMNB injections

Timeframe: Day 2 15 minutes post TMNB injection

Trial details

NCT IDNCT07094542

SponsorRutgers, The State University of New Jersey

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-11

Contact for this trial

Gayathri D Subramanian, PhD, DMD

7328247241 subramga@sdm.rutgers.edu

View on ClinicalTrials.gov More Post Operative Pain trials