Characterization of the Temporo-masseteric Nerve Block (TMNB) in Healthy Subjects
Recruiting now · Phase 2
Conditions studied: Occlusion
In brief
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).
Key facts
- Study ID
- NCT05507164
- Run by
- Rutgers, The State University of New Jersey
- People needed
- 20
- Starts
- 2022-10-10
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2025-12-05
Who can join
Age: 18 and older, up to 64. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
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
Where it is running
- Rutgers School of Dental Medicine — Newark, New Jersey, United States (enrolling)
Full record on ClinicalTrials.gov
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