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

• Status: Not yet recruiting
• Trial end date: 2023-03-31
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Rutgers, The State University of New Jersey

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