Health TrialsbyHealthPanel

Jaw Muscle Pain Post Wisdom Molar Surgery

ConditionsPost Operative PainImpacted Third Molar ToothMuscle Pain
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorRutgers, The State University of New Jersey

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

80 Participants
are divided into 3 treatment groups
Group A: ControlActive comparator 1 intervention
Group B: TMNB with PlaceboActive comparator 1 intervention
Group C: TMNB with dental local anestheticExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Jaw Muscle Pain Reduction on palpation post-TMNB injections

To assess the effect of TMNB injection on the Numerical Pain Rating Scale (NRS) corresponding to Jaw muscle pain-to-palpation reported by the participant, when assessed 15 minutes post-injection.

Time frame
Day 2 15 minutes post TMNB injection

Secondary outcomes

1

Sustained Benefit from TMNB Injection- pain reduction

Comparison of peak NRS pain score, the highest pain level as perceived by the participant collected for the preceding 24 hours.

Time frame
24-, 48-, 72-, and 96- hours post-injection
2

Sustained Benefit from TMNB Injection- mouth opening

Comparison of spontaneous maximum mouth opening, measured in millimeters

Time frame
24-, 48-, 72-, and 96- hours post-injection
3

Opioid consumption to 'rescue' pain poorly responsive to recommended pain medication regimen

Compare need for rescue opioid medication among the three groups

Time frame
8 Days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Rutgers, The State University of New Jersey

Lead sponsor

National Institute of Dental and Craniofacial Research (NIDCR)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: