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Nerve Block for Jaw Pain
Phase 2
Recruiting
Led By Gayathri D Subramanian, DMD
Research Sponsored by Rutgers, The State University of New Jersey
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 30 min, 2 hours and 2 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial will test a new injection for TMJ pain in 20 people. Outcomes will be measured by force and electrical activity in the jaw muscles, and participants will be surveyed about their experience.
Who is the study for?
This trial is for healthy adults aged 18-64 who speak English, can open their mouth and move their jaw without pain or stiffness, have not been diagnosed with TMD (jaw disorder), and do not have a significant history of facial pain. Excluded are those with kidney failure, seizures, recent facial trauma/surgery, heart disease, uncontrolled chronic conditions like hypertension/diabetes, substance abuse issues, psychiatric hospitalizations, cancer treatments or hyperthyroidism.
What is being tested?
The study tests the Temporomasseteric Nerve Block (TMNB) on healthy volunteers to see how it affects bite-force distribution and muscle activity in the jaw. Participants will be evaluated at different times after receiving the TMNB injection to measure its effects on muscle function.
What are the potential side effects?
While specific side effects are not listed for this trial of healthy subjects receiving TMNB injections, potential risks may include discomfort at the injection site, temporary numbness or weakness in jaw muscles, bruising or swelling.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 30 min, 2 hours and 2 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 30 min, 2 hours and 2 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Bite force distribution
Change in Surface EMG
Survey
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Temporo-masseteric Nerve Block AdministrationExperimental Treatment1 Intervention
Non-randomized administration of the TMNB injection (unilateral) followed by bite force distribution and surface EMG assessment of the temporalis and masseter muscles on the side of the injection
Find a Location
Who is running the clinical trial?
Rutgers, The State University of New JerseyLead Sponsor
455 Previous Clinical Trials
69,931 Total Patients Enrolled
Gayathri D Subramanian, DMDPrincipal InvestigatorRutgers School of Dental Medicine
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently undergoing orthodontic treatment.I have had a recent injury or surgery on my face or jaw within the last 6 months.I am either male or female.I have heart disease or heart failure.I have never been diagnosed with TMD.I am on dialysis or have kidney failure.I have a history of seizures, thyroid issues, substance abuse, or psychiatric conditions.I don't have a history of significant face or mouth pain.I do not have uncontrolled breathing problems, high blood pressure, or diabetes.I've had fewer than 5 headaches a month in the last 3 months.I have not experienced jaw or temple pain, stiffness, or discomfort in the last 30 days.I am between 18 and 64 years old.