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Twin Block, Pain Medications and Third Molar Extractions

NCT04880707 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2025-10-07

No results posted yet for this 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.

Conditions

  • Acute Pain

Interventions

DRUG

Twin block local anesthetic nerve block using standard dental anesthetic

2% lidocaine with 1:100,000 epinephrine is the standard dental local anesthetic in universal use. This drug will be administered as the Twin block local anesthetic nerve block targeting the branches of the mandibular nerve supplying the temporalis and masseter muscles.

OTHER

Twin block with placebo

Instead of the standard dental anesthetic, sterile normal saline will be delivered using the Twin block injection

Sponsors & Collaborators

  • New Jersey Health Foundation

    collaborator OTHER

  • Rutgers, The State University of New Jersey

    lead OTHER

Principal Investigators

  • Gayathri Subramanian, PhD, DMD · Rutgers School of Dental Medicine, Newark NJ

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-11
Primary Completion
2026-02-28
Completion
2026-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04880707 on ClinicalTrials.gov