Recruiting
Phase 2

TMNB

Sponsor:

Rutgers, The State University of New Jersey

Code:

NCT05507164

Conditions

Occlusion

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Accepted

Interventions

Temporomasseteric Nerve Block

Study Details

Brief summary:

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).

Conditions

Occlusion

Study ID

NCT05507164

Start date

Oct 10, 2022

Status verified date

Dec, 2025

Completion date

Dec, 2026

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 18-64 years of age
  • All ethnicity
  • Male and female sex
  • Fluent in written/spoken English
  • Never been diagnosed with TMD
  • No significant history of orofacial pain
  • <5 headaches/month in the 3 months before enrollment
  • No reported use of a nightguard or occlusal splint 'No' to all questions on self-administered questionnaire for TMD screening:
  • Pain in jaw or temple on either side of the face in the last 30 days
  • Stiffness or pain in jaw upon awakening in the last 30 days
  • Any pain increase/reduction in the jaw/temple region during the last 30 days with

  • Chewing hard or tough food
  • Opening mouth or moving jaw forward or to the side
  • Hold teeth together/clenching/grinding/chewing gum
  • Using the jaw during activities such as talking, kissing or yawning

Exclusion Criteria:

  • Traumatic injury/ surgery on face or jaw < 6 months
  • current orthodontic treatment
  • pregnant or nursing,
  • kidney failure or renal dialysis,
  • heart disease or heart failure,
  • uncontrolled chronic respiratory disease/ hypertension/ diabetes
  • history of
  • seizures
  • hyperthyroidism
  • drug or alcohol abuse
  • psychiatric disorder/conditions requiring hospitalization
  • chemotherapy/radiation

Study Design

Enrollment

20 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

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

Interventions

Temporomasseteric Nerve Block

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.

Primary outcome measure

  • Change in Bite force distribution [ Time Frame: Baseline, 30 min, 2 hours and 2 weeks ]
  • Change in Surface EMG [ Time Frame: Baseline, 30 min, 2 hours and 2 weeks ]
  • Survey [ Time Frame: At 2 weeks post injection ]

Central Contacts and Locations

Central contacts

Gayathri D Subramanian

9739723418subramga@sdm.rutgers.edu

Locations

Rutgers School of Dental Medicine

Recruiting

Newark, New Jersey, United States, 07103

Contacts

Gayathri Subramanian

973-972-3418subramga@sdm.rutgers.edu

More Information

Sponsor

Rutgers, The State University of New Jersey

Last update posted

Dec 5, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Rutgers, The State University of New Jersey on 2025-12-05.