RECRUITING

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

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

Non-randomized Pilot Study to Characterize Temporo-masseteric Nerve Block (TMNB) in

Quick Facts

Study Start:2022-10-10
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05507164

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 64 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * 18-64 years of age
  2. * All ethnicity
  3. * Male and female sex
  4. * Fluent in written/spoken English
  5. * Never been diagnosed with TMD
  6. * No significant history of orofacial pain
  7. * \<5 headaches/month in the 3 months before enrollment
  8. * No reported use of a nightguard or occlusal splint 'No' to all questions on self-administered questionnaire for TMD screening:
  9. * Pain in jaw or temple on either side of the face in the last 30 days
  10. * Stiffness or pain in jaw upon awakening in the last 30 days
  11. * Any pain increase/reduction in the jaw/temple region during the last 30 days with
  12. * Chewing hard or tough food
  13. * Opening mouth or moving jaw forward or to the side
  14. * Hold teeth together/clenching/grinding/chewing gum
  15. * Using the jaw during activities such as talking, kissing or yawning
  1. * Traumatic injury/ surgery on face or jaw \< 6 months
  2. * current orthodontic treatment
  3. * pregnant or nursing,
  4. * kidney failure or renal dialysis,
  5. * heart disease or heart failure,
  6. * uncontrolled chronic respiratory disease/ hypertension/ diabetes
  7. * history of
  8. * seizures
  9. * hyperthyroidism
  10. * drug or alcohol abuse
  11. * psychiatric disorder/conditions requiring hospitalization
  12. * chemotherapy/radiation

Contacts and Locations

Study Contact

Gayathri D Subramanian
CONTACT
9739723418
subramga@sdm.rutgers.edu

Principal Investigator

Gayathri D Subramanian, DMD
PRINCIPAL_INVESTIGATOR
Rutgers School of Dental Medicine

Study Locations (Sites)

Rutgers School of Dental Medicine
Newark, New Jersey, 07103
United States

Collaborators and Investigators

Sponsor: Rutgers, The State University of New Jersey

  • Gayathri D Subramanian, DMD, PRINCIPAL_INVESTIGATOR, Rutgers School of Dental Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-10-10
Study Completion Date2025-12

Study Record Updates

Study Start Date2022-10-10
Study Completion Date2025-12

Terms related to this study

Additional Relevant MeSH Terms

  • Occlusion