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Temporo-masseteric Nerve Block Administration for Blockage

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

Study 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.Check my eligibility

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.See study design

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 30 min, 2 hours and 2 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Bite force distribution

Change in Surface EMG

Survey

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Rutgers, The State University of New JerseyLead Sponsor

429 Previous Clinical Trials

64,212 Total Patients Enrolled

Gayathri D Subramanian, DMDPrincipal InvestigatorRutgers School of Dental Medicine

Media Library

Temporo-masseteric Nerve Block Administration Clinical Trial Eligibility Overview. Trial Name: NCT05507164 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the odds of experiencing side effects from this medication?

"While Phase 2 trials do not have the same level of data supporting efficacy, this treatment received a score of 2 for safety."

Answered by AI

How many study participants are needed for this clinical trial?

"Yes, that is correct. The information available on clinicaltrials.gov makes it clear that this study is still looking for patients to enroll. 20 individuals are needed in total from 1 medical facility, and the trial was originally posted on October 10th, 2022 with a recent update on the 24th of October."

Answered by AI

Are individuals outside of the age range of 50 being recruited for this experiment?

"Eligibility for this study requires that potential participants are aged between 18 and 64 years old."

Answered by AI

Would I be a good candidate to join this clinical study?

"Eligible patients for this clinical trial will have occlusion and be between 18-64 years old. Up to 20 participants can take part in the study."

Answered by AI

Are researchers looking for more participants in this trial?

"Indeed, the clinicaltrials.gov website contains information suggesting that this study is actively recruiting patients as of 10/24/2022. 20 individuals are needed for the trial which is set to take place at a single location."

Answered by AI

Recent research and studies

Anesthesia ProgressJournal

Twin Block in Myogenous Orofacial Pain: Applied Anatomy, Technique Update, and Safety

Quek, Samuel Y. P., Julyana Gomes-Zagury, and Gayathri Subramanian. 2020. “Twin Block in Myogenous Orofacial Pain: Applied Anatomy, Technique Update, and Safety”. Anesthesia Progress. American Dental Society of Anesthesiology (ADSA). doi:10.2344/anpr-67-01-03.

Oral Surgery, Oral Medicine, Oral Pathology and Oral RadiologyJournal

The Effect of the Twin Block Compared with Trigger Point Injections in Patients with Masticatory Myofascial Pain: A Pilot Study

Ananthan, Sowmya, Veena Kanti, Julyana Gomes Zagury, Samuel Y.P. Quek, and Rafael Benoliel. 2020. “The Effect of the Twin Block Compared with Trigger Point Injections in Patients with Masticatory Myofascial Pain: A Pilot Study”. Oral Surgery, Oral Medicine, Oral Pathology and Oral Radiology. Elsevier BV. doi:10.1016/j.oooo.2019.09.014.

The Journal of the American Dental AssociationJournal

Executive Summary of the Diagnostic Criteria for Temporomandibular Disorders for Clinical and Research Applications

Schiffman, Eric, and Richard Ohrbach. 2016. “Executive Summary of the Diagnostic Criteria for Temporomandibular Disorders for Clinical and Research Applications”. The Journal of the American Dental Association. Elsevier BV. doi:10.1016/j.adaj.2016.01.007.

Oral Surgery, Oral Medicine, Oral Pathology and Oral RadiologyJournal