Characterization of the Temporo-masseteric Nerve Block (TMNB) in Healthy Subjects

Conditions

• Occlusion

Eligibility Criteria

Sex

ALL

Age

18 Years - 64 Years

Healthy Volunteers

Accepted

Interventions

• Temporomasseteric Nerve Block — DRUG
  The TMNB injection is a local anesthetic injection technique that targets the anterior deep temporal and masseteric branches of the mandibular division of the Trigeminal Nerve. The surface landmark for the twin block injection site is located by palpating for the depression created by the greater wing of the sphenoid bone at the superior border of the zygomatic process and approximately 1 cm posterior to the posterior border of the frontal process of the zygomatic bone. This site is first disinfected with alcohol wipes prior to inserting a 27- or 25-gauge long dental needle (32 mm). Angled 35-45° away from the calvarium (skull) and perpendicular to the zygomatic arch (along the coronal plane), the needle is advanced to its length before injecting 1.8 mL of 2% lidocaine with 1:100,000 epinephrine.

Study Details

The proposed pilot study is aimed at preliminary characterization of the TMNB injection in 20 healthy volunteers. Assessment of bite-force distribution and surface electromyographic activity of the temporalis and the masseter muscles, at rest and clench, before and after unilateral TMNB injection, will be the primary outcome measures. Post-injection assessments will be performed at 30 minutes, 2 hours, and 2 weeks after the injection. Participants will be surveyed regarding their experience receiving the TMNB injection (secondary outcomes).

Key Dates

Start date

Oct 10, 2022

Status verified

Dec 2025

Primary completion

Sep 30, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

20 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Arms

• Other: Temporo-masseteric Nerve Block Administration
  Non-randomized administration of the TMNB injection (unilateral) followed by bite force distribution and surface EMG assessment of the temporalis and masseter muscles on the side of the injection

Primary Outcome Measure

Change in Bite force distribution [ Time Frame: Baseline, 30 min, 2 hours and 2 weeks ]

Central Contacts

• Gayathri D Subramanian
  9739723418
  [email protected]

Locations (1)

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