Health TrialsbyHealthPanel

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

ConditionOcclusion
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-64
SponsorRutgers, The State University of New Jersey

About this trial

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).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

18-64 years of age

All ethnicity

Male and female sex

Fluent in written/spoken English

Disqualifiers

Traumatic injury/ surgery on face or jaw < 6 months

current orthodontic treatment

pregnant or nursing,

kidney failure or renal dialysis,

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Temporo-masseteric Nerve Block AdministrationOther 1 intervention

Trial outcomes

Primary outcomes

1

Change in Bite force distribution

Left vs Right distribution of bite force upon clenching will be assessed as an average of 3 consequent measurements.

Time frame
Baseline, 30 min, 2 hours and 2 weeks
2

Change in Surface EMG

Surface EMG will be utilized to measure surface electrical activity over the temporalis and masseter muscles at rest and clenching

Time frame
Baseline, 30 min, 2 hours and 2 weeks
3

Survey

All subjects will be surveyed for their experience as part of their participation in the study

Time frame
At 2 weeks post injection

Secondary outcomes

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

Source ClinicalTrials.gov
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