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New treatment option for Occlusion
Official title Characterization of the Temporo-masseteric Nerve Block (TMNB) in Healthy Subjects
ClinicalTrials.gov ID: NCT05507164
What this study is testing
What is Temporomasseteric Nerve Block?
Temporomasseteric Nerve Block is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for occlusion.
Also referred to as Twin Block.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 64. Healthy volunteers may be eligible.
You may be able to join if
- 18-64 years of age
- All ethnicity
- Male and female sex
- Fluent in written/spoken English
- Never been diagnosed with TMD
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Newark, New Jersey, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 64 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Newark, New Jersey, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.