Exploring the Temporo-masseteric Nerve Block in Healthy Volunteers
Non-randomized Pilot Study to Characterize Temporo-masseteric Nerve Block (TMNB) in
This study is testing how a specific nerve block injection affects muscle activity and bite strength in healthy volunteers to see if it can help with pain relief.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 64 Years |
| Sex | All |
| Sponsor | Rutgers, The State University of New Jersey Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Newark, New Jersey) |
| Trial ID | NCT05507164 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to characterize the Temporo-masseteric Nerve Block (TMNB) injection in 20 healthy volunteers. It will assess bite-force distribution and surface electromyographic activity of the temporalis and masseter muscles before and after the TMNB injection. Evaluations will occur at 30 minutes, 2 hours, and 2 weeks post-injection, with participants also providing feedback on their experience. The study seeks to understand the TMNB's effects on muscle activity and its potential for sustained pain relief.
Who should consider this trial
Good fit: Ideal candidates are healthy adults aged 18-64 who have no history of temporomandibular disorders or significant orofacial pain.
Not a fit: Patients with a history of temporomandibular disorders, significant orofacial pain, or those currently undergoing orthodontic treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of TMNB's effectiveness in managing myogenous pain, potentially leading to improved treatment options.
How similar studies have performed: While the TMNB approach is emerging, similar nerve blocks have shown promise in pain management, suggesting potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Newark, New Jersey
- Rutgers School of Dental Medicine — Newark, New Jersey, United States (Recruiting)
Study contacts
- Principal investigator: Gayathri D Subramanian, DMD — Rutgers School of Dental Medicine
- Study coordinator: Gayathri D Subramanian
- Email: subramga@sdm.rutgers.edu
- Phone: 9739723418
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.