Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT04880707

Twin Block, Pain Medications and Third Molar Extractions

Led by Rutgers, The State University of New Jersey · Updated on 2025-10-07

48

Participants Needed

1

Research Sites

124 weeks

Total Duration

On this page

Sponsors

R

Rutgers, The State University of New Jersey

Lead Sponsor

N

New Jersey Health Foundation

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Twin Block, Pain Medications and Third Molar Extractions

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients requiring extraction of at least one lower wisdom (third) molar that is partially or fully impacted under intravenous sedation
  • Age older than 18 years
  • Healthy individuals
  • No cognitive or intellectual disability
  • No past or recent pain or reduced jaw joint or muscle movement, no trauma or surgery in the jaw area
  • Access to an electronic device such as a smartphone, tablet, or computer with internet connection
  • Willingness to participate and not excluded by exclusion criteria
Not Eligible

You will not qualify if you...

  • Compromised ability to protect own interests, including prisoners, children, pregnant women, or those with intellectual or cognitive disabilities
  • Infection or inflammation involving the third molars on the day of extraction
  • Past use of opioid pain medication for short-term or long-term pain or current long-term anti-inflammatory pain medication
  • Long-standing pain in the jaw joint or muscles
  • Allergy or intolerance to dental local anesthetic or its components, opioids, acetaminophen (Tylenol), or ibuprofen (Motrin or Advil)

AI-Screening

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Trial Site Locations

Total: 1 location

1

Rutgers School of Dental Medicine

Newark, New Jersey, United States, 07103

Actively Recruiting

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Research Team

G

Gayathri Subramanian, PhD, DMD

CONTACT

B

Brahmleen Kaur, DMD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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Twin Block, Pain Medications and Third Molar Extractions | DecenTrialz