EICHORCondition: Occlusion · Sponsor: Rutgers, The State University of New Jersey
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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).
This description comes directly from the study's public registry record.
Gayathri D Subramanian · 9739723418 · subramga@sdm.rutgers.edu
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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
Reproduced word-for-word from the public registry record — the study team can answer questions about it.
| Rutgers School of Dental Medicine | Newark, New Jersey, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT05507164