Jaw Muscle Pain Post Wisdom Molar Surgery

Part of paid clinical trials in Newark, New Jersey.

Sponsor
Rutgers, The State University of New Jersey
Study ID
NCT07094542
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Impacted Third Molar Tooth
  • Muscle Pain
  • Post Operative Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Temporo-masseteric Nerve Block Injection — DRUG
    The TMNB injection/placebo will be administered by the Principal Investigator. The injection will only be delivered on Day 2 on the side/s of significant jaw muscle pain. Following disinfection of skin overlying the suprazygomatic injection site, a single carpule of 1.8 ml 2% lidocaine with 1:100,000 epinephrine will be delivered using a 25- or 27- gauge 30 mm needle). The injection site will be approximately a centimeter above the zygomatic arch, and a centimeter behind the palpable posterior border of the frontal process of the zygomatic bone. The needle will be directed at a 45-degree downward angle, directed medially along the coronal plane. At the depth of insertion of the needle, the local anesthetic/placebo will be delivered.
  • Oral Pain Medications only — DRUG
    For participants with jaw muscle pain to palpation \<5 NRS score, no additional injection will be given. The participant will take the recommended pain medications as described.

Study Details

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.

Key Dates

Start date
May 31, 2026
Status verified
Mar 2026
Primary completion
Nov 30, 2029
Completion
May 31, 2030

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Control
    Participants whose jaw muscle pain to palpation is \<5 on Numerical Pain Rating Scale (NRS) the day after lower wisdom molar removal under sedation will be recommended post-operative pain management with a fixed interval dosing of ibuprofen 600 mg along with acetaminophen 325 mg taken every 6 hours for the first 72 hours post-procedure, after which they are encouraged to take prn dosing.
  • Active Comparator: TMNB with Placebo
    Participants whose jaw muscle pain to palpation is 5 or higher on on Numerical Pain Rating Scale (NRS) the day after lower wisdom molar removal under sedation will be randomized to either placebo (sterile saline) or to the dental local anesthetic. The placebo will be delivered as the Temporo-masseteric Nerve Block injection. The randomization is blind to the participant and to the investigator administering the injection. The participants will be recommended post-operative pain management with a fixed interval dosing of ibuprofen 600 mg along with acetaminophen 325 mg taken every 6 hours for the first 72 hours post-procedure, after which they are encouraged to take prn dosing.
  • Experimental: TMNB with dental local anesthetic
    Participants whose jaw muscle pain to palpation is 5 or higher on on Numerical Pain Rating Scale (NRS) the day after lower wisdom molar removal under sedation will be randomized to either placebo (sterile saline) or to the dental local anesthetic. The dental local anesthetic (2% lidocaine with 1:100,000 epinephrine) will be delivered as the Temporo-masseteric Nerve Block injection. The randomization is blind to the participant and to the investigator administering the injection. The participants will be recommended post-operative pain management with a fixed interval dosing of ibuprofen 600 mg along with acetaminophen 325 mg taken every 6 hours for the first 72 hours post-procedure, after which they are encouraged to take prn dosing.

Primary Outcome Measure

Jaw Muscle Pain Reduction on palpation post-TMNB injections [ Time Frame: Day 2 15 minutes post TMNB injection ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Rutgers School of Dental MedicineNewarkNew Jersey07103-

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By research site
Rutgers School of Dental Medicine· Newark, NJ

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