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

NCT05507164 | Recruiting Phase 2 DMC

• 1 other identifier: Pro2022000182
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• Change in Bite force distribution

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

  Baseline, 30 min, 2 hours and 2 weeks

• Change in Surface EMG

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

  Baseline, 30 min, 2 hours and 2 weeks

• Survey

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

  At 2 weeks post injection

Study Arms (1)

Temporo-masseteric Nerve Block Administration

OTHER

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

Drug: Temporomasseteric Nerve Block

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.

Also known as: Twin Block

Temporo-masseteric Nerve Block Administration

Eligibility Criteria

• Age: 18 Years - 64 Years
• Gender Eligibility Details: 10 males and 10 female subjects will be enrolled in the study
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Sites (1)

Rutgers School of Dental Medicine

Newark, New Jersey, 07103, United States

RECRUITING

Related Publications (6)

• Quek S, Young A, Subramanian G. The twin block: a simple technique to block both the masseteric and the anterior deep temporal nerves with one anesthetic injection. Oral Surg Oral Med Oral Pathol Oral Radiol. 2014 Sep;118(3):e65-7. doi: 10.1016/j.oooo.2014.01.227. Epub 2014 Feb 6.

  PMID: 24703404 BACKGROUND

• Ananthan S, Kanti V, Zagury JG, Quek SYP, Benoliel R. The effect of the twin block compared with trigger point injections in patients with masticatory myofascial pain: a pilot study. Oral Surg Oral Med Oral Pathol Oral Radiol. 2020 Mar;129(3):222-228. doi: 10.1016/j.oooo.2019.09.014. Epub 2019 Oct 13.

  PMID: 32009005 BACKGROUND

• Quek SYP, Kalladka M, Kanti V, Subramanian G. A new adjunctive tool to aid in the diagnosis of myogenous temporomandibular disorder pain originating from the masseter and temporalis muscles: Twin-block technique. J Indian Prosthodont Soc. 2018 Apr-Jun;18(2):181-185. doi: 10.4103/jips.jips_293_17.

  PMID: 29692573 BACKGROUND

• Kanti V, Ananthan S, Subramanian G, Quek SYP. Efficacy of the twin block, a peripheral nerve block for the management of chronic masticatory myofascial pain: A case series. Quintessence Int. 2017 Oct 6:725-729. doi: 10.3290/j.qi.a39094. Online ahead of print.

  PMID: 28990015 BACKGROUND

• Schiffman E, Ohrbach R. Executive summary of the Diagnostic Criteria for Temporomandibular Disorders for clinical and research applications. J Am Dent Assoc. 2016 Jun;147(6):438-45. doi: 10.1016/j.adaj.2016.01.007. Epub 2016 Feb 26.

  PMID: 26922248 BACKGROUND

• Quek SYP, Gomes-Zagury J, Subramanian G. Twin Block in Myogenous Orofacial Pain: Applied Anatomy, Technique Update, and Safety. Anesth Prog. 2020 Jun 1;67(2):103-106. doi: 10.2344/anpr-67-01-03.

  PMID: 32633773 BACKGROUND

MeSH Terms

Conditions

Bites and Stings

Condition Hierarchy (Ancestors)

Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Study Officials

• Gayathri D Subramanian, DMD

  Rutgers School of Dental Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gayathri D Subramanian

CONTACT

9739723418; subramga@sdm.rutgers.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 11, 2022
• First Posted: August 18, 2022
• Study Start: October 10, 2022
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 5, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Within 4 weeks of approved request after study completion, at time of publication
• Access Criteria: By individual request

Locations

US (1)