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NCT04880707 · ClinicalTrials.gov registry record · Phase 2
Twin Block, Pain Medications and Third Molar Extractions
A Phase 2 study of Acute Pain, sponsored by Rutgers, The State University of New Jersey.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 48
- Enrollment target
- 1
- Study location
NCT04880707: Recruiting Phase 2 study of Acute Pain, sponsored by Rutgers, The State University of New Jersey.
NCT04880707 is a Phase 2 study of Acute Pain that is actively recruiting participants, run by Rutgers, The State University of New Jersey. The registered enrollment target is 48 participants, below the 267-participant average among 50 other Acute Pain trials with a reported enrollment target (82% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04880707, a Phase 2 study of Acute Pain, is actively recruiting participants, sponsored by Rutgers, The State University of New Jersey.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 48 participants
- Enrollment target
- 1
- Study location
Study Summary
Each year, over 3.5 million, mostly, healthy young adults, have their third molar teeth ('wisdom teeth') removed under sedation and are often given opioid prescriptions for managing their pain. Wisdom molar removal is one of the most common reasons for opioid prescriptions to be given to adolescents. There is a national thrust to reduce both the dose and the duration of such opioid prescriptions because even short-term opioid exposures increase risk for narcotic addiction and misuse. Non-opioid options to manage pain will still allow for sufficient pain control without risking addiction, and hence, a fundamental component of our response to combat the current national opioid crisis. The investigators are going to study a promising option- the Twin Block dental anesthetic injection. The Twin block involves injecting the standard dental numbing medication in a way that 'numbs' the 'jaw-clencher' muscles on the side of the face. The investigators found that the Twin block relieved jaw pain stemming from these muscles, in a quick and sustained manner, even in patients whose pain following wisdom tooth removal primarily came from 'taut' and tender jaw-clencher muscles. However, what is not known is- how often do patients who have their wisdom teeth removed under sedation, end up in significant pain from taut and tender jaw-clencher muscles? Will using the twin block effectively reduce pain in such patients? In this pilot study, the investigators will examine wisdom molar extraction patients one day after their procedure. Those with significant pain (pain rated ≥ 5 on a 0-10 scale) in their jaw-clencher muscles, will get either the Twin block injection or a placebo. The investigators will track both 1) pain before and after the injection, and 2) pain medication usage over a 7-day period to see if both pain and opioid dosage come down with the Twin block. This study can support a simple, safe and inexpensive means to reduce pain after a common procedure.
Primary Outcome
NRS pain scores before and 15 min after Twin block administration on day after procedure
Conditions Studied
Interventions
- DRUG Twin block local anesthetic nerve block using standard dental anesthetic
- OTHER Twin block with placebo
Study Locations (1)
New Jersey
- Rutgers School of Dental Medicine - Newark
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2024-03-11 |
| Est. Completion | 2026-08 |
| Phase | Phase 2 |
What NCT04880707 shows while recruiting
NCT04880707 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 267-participant average among 50 other Acute Pain trials with a reported enrollment target (82% lower).
The record links to 1 condition, with Acute Pain appearing as the primary indexed condition, and to 2 interventions - of which Twin block local anesthetic nerve block using standard dental anesthetic is the first listed.
NCT04880707 reports a single indexed study location in New Jersey.
Frequently Asked Questions
What is clinical trial NCT04880707 about?
NCT04880707 is a clinical study titled "Twin Block, Pain Medications and Third Molar Extractions". Each year, over 3.5 million, mostly, healthy young adults, have their third molar teeth ('wisdom teeth') removed under sedation and are often given opioid prescriptions for managing their pain. Wisdom molar removal is one of the most common reasons for opioid prescriptions to be given to adolescents...
What is the current status of trial NCT04880707?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 48 participants. The study started on 2024-03-11. Estimated completion is 2026-08.
What conditions does trial NCT04880707 study?
This clinical trial studies the following conditions: Acute Pain.
What interventions are being tested in trial NCT04880707?
The interventions under investigation include: Twin block local anesthetic nerve block using standard dental anesthetic (DRUG), Twin block with placebo (OTHER).
Who is sponsoring clinical trial NCT04880707?
This trial is sponsored by Rutgers, The State University of New Jersey, which has 413 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04880707 being conducted?
This trial has 1 study location across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04880707's enrollment target sits among peer trials
48 40th of 50 higher than 10 of 50 other Acute Pain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Pain trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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