Actively Recruiting

Phase 2
Age: 18Years - 64Years
All Genders
Healthy Volunteers
ID05507164

Non-randomized Pilot Study to Characterize the Temporo-masseteric Nerve Block in Healthy Adults

Led by Rutgers, The State University of New Jersey · Updated on 2025-12-05

20

Participants Needed

1

Research Sites

13 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the Temporo-masseteric Nerve Block (TMNB) injection in healthy adults aged 18 to 64 to better understand its effects on jaw muscles. The TMNB targets specific nerves supplying the temporalis and masseter muscles, which are involved in jaw closure and clenching. This pilot study aims to explore how TMNB changes bite force and muscle activity, shedding light on its potential for relieving jaw muscle pain. The study involves a single group of 20 healthy volunteers receiving a unilateral TMNB injection using 1.8 mL of 2% lidocaine with epinephrine. The injection targets nerve branches of the mandibular division of the trigeminal nerve. The side of injection (left or right) is randomly assigned. Assessments of bite force distribution and surface electromyographic activity of the temporalis and masseter muscles will be performed before injection and at 30 minutes, 2 hours, and 2 weeks after. Participants will undergo bite force and muscle activity tests at rest and during clenching using specialized devices. They will also complete surveys about their experience with the injection on the day of treatment and again at 2 weeks. The study monitors changes over time to capture both immediate and longer-term effects. The total study duration per participant is 2 weeks, with safety and tolerability closely observed throughout.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 64Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 64 years
  • Male or female sex
  • Fluent in written and spoken English
  • No previous diagnosis of Temporomandibular Disorder (TMD)
  • No significant history of orofacial pain
  • Experiencing fewer than 5 headaches per month in the past 3 months
  • No use of nightguard or occlusal splint
  • No pain or stiffness in jaw or temple on either side in the last 30 days
  • No pain changes in jaw/temple during chewing, mouth opening, clenching, grinding, or jaw use in the last 30 days
Not Eligible

You will not qualify if you...

  • Traumatic injury or surgery on face or jaw within the past 6 months
  • Current orthodontic treatment
  • Pregnant or nursing
  • Kidney failure or on renal dialysis
  • Heart disease or heart failure
  • Uncontrolled chronic respiratory disease, hypertension, or diabetes
  • History of seizures
  • Hyperthyroidism
  • Drug or alcohol abuse
  • Psychiatric disorders requiring hospitalization
  • Currently undergoing chemotherapy or radiation therapy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Single administration with follow-up assessments over 2 weeks

Participants receive a unilateral Temporo-masseteric Nerve Block (TMNB) injection, a local anesthetic targeting specific nerve branches in the jaw muscles.

1 injection visit and 3 assessment visits at 30 minutes, 2 hours, and 2 weeks post-injection

Follow-up

Duration - 2 weeks following the injection

Participants are monitored for changes in bite force distribution and muscle activity, and surveyed about their experience with the TMNB injection.

Survey administered on injection day and at 2 weeks post-injection

Trial Site Locations

Total: 1 location

1

Rutgers School of Dental Medicine

Newark, New Jersey, United States, 07103

Actively Recruiting

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Research Team

G

Gayathri D Subramanian

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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Frequently Asked Questions

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Published Research Related To This Trial

The twin block: a simple technique to block both the masseteric and the anterior deep temporal nerves with one anesthetic injection.

Samuel Quek, Andrew Young, Gayathri Subramanian

https://pubmed.ncbi.nlm.nih.gov/24703404

The effect of the twin block compared with trigger point injections in patients with masticatory myofascial pain: a pilot study.

Sowmya Ananthan, Veena Kanti, Julyana Gomes Zagury...

https://pubmed.ncbi.nlm.nih.gov/32009005

A new adjunctive tool to aid in the diagnosis of myogenous temporomandibular disorder pain originating from the masseter and temporalis muscles: Twin-block technique.

Samuel Y P Quek, Mythili Kalladka, Veena Kanti...

https://pubmed.ncbi.nlm.nih.gov/29692573

Efficacy of the twin block, a peripheral nerve block for the management of chronic masticatory myofascial pain: A case series.

Veena Kanti, Sowmya Ananthan, Gayathri Subramanian...

https://pubmed.ncbi.nlm.nih.gov/28990015