NCT05507164 Characterization of the Temporo-masseteric Nerve Block (TMNB) in Healthy Subjects
| NCT ID | NCT05507164 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Rutgers, The State University of New Jersey |
| Condition | Occlusion |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2022-10-10 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 20 participants in total. It began in 2022-10-10 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
Eligibility 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
Contact & Investigator
Gayathri D Subramanian, DMD
PRINCIPAL INVESTIGATOR
Rutgers School of Dental Medicine
Frequently Asked Questions
Who can join the NCT05507164 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 64 Years, studying Occlusion. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05507164 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05507164 currently recruiting?
Yes, NCT05507164 is actively recruiting participants. Contact the research team at subramga@sdm.rutgers.edu for enrollment information.
Where is the NCT05507164 trial being conducted?
This trial is being conducted at Newark, United States.
Who is sponsoring the NCT05507164 clinical trial?
NCT05507164 is sponsored by Rutgers, The State University of New Jersey. The principal investigator is Gayathri D Subramanian, DMD at Rutgers School of Dental Medicine. The trial plans to enroll 20 participants.