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Recruiting Phase 2 NCT05335070

NCT05335070 Reducing Pain From Wisdom Molar Extractions

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Clinical Trial Summary
NCT ID NCT05335070
Status Recruiting
Phase Phase 2
Sponsor Rutgers, The State University of New Jersey
Condition Acute Pain
Study Type INTERVENTIONAL
Enrollment 20 participants
Start Date 2022-09-13
Primary Completion 2026-11

Trial Parameters

Condition Acute Pain
Sponsor Rutgers, The State University of New Jersey
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 20
Sex ALL
Min Age 18 Years
Max Age 64 Years
Start Date 2022-09-13
Completion 2026-11
Interventions
Temporo-masseteric Nerve Block

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Brief Summary

This is a pilot study evaluating the ability of the Temporo-masseteric Nerve Block local anesthetic injection (this was called the Twin Block earlier) to reduce pain experienced by individuals undergoing removal of lower third molar(s) under intravenous sedation. Study participants will be queried for pain experience and pain medications taken during the first post-operative week and will present for a follow-up visit on Day 8.

Eligibility Criteria

Inclusion Criteria: * Age 18 years of age or older (up to 64 years) * Any demographic * ASA 1 and 2 (mild or absent systemic illnesses, deemed fit for undergoing dental extractions under intravenous sedation) * Not pregnant (as will not qualify to undergo procedure under intravenous sedation as part of routine standard-of-care) * Adequate mental ability to understand and provide informed consent * Has smart phone and internet connection Exclusion Criteria: * Age older than 64 years (because they are poor candidates for undergoing procedures under intravenous sedation) * Pregnant * Incapable of providing informed consent * Any systemic condition that renders the patient at higher risk for complications under intravenous sedation * Documented allergy to the dental local anesthetic * Inability to tolerate any of the commonly used pain medications such as combination opioids, acetaminophen (Tylenol®) or ibuprofen (Motrin® or Advil®) * Limitation in adequate mouth opening in presence/absenc

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