Twin Block, Pain Medications and Third Molar Extractions

Conditions

• Acute Pain

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Twin block local anesthetic nerve block using standard dental anesthetic — DRUG
  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.
• Twin block with placebo — OTHER
  Instead of the standard dental anesthetic, sterile normal saline will be delivered using the Twin block injection

Study Details

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.

Key Dates

Start date

Mar 11, 2024

Status verified

Oct 2025

Primary completion

Feb 28, 2026

Completion

Aug 31, 2026

Study Design

Enrollment

48 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Arms

• Active Comparator: Twin Block with Local Anesthetic
  Following lower third molar extraction under intravenous sedation, the patient randomized to this arm with receive the Twin block local anesthetic nerve block using the standard dental local anesthetic, i.e,. 2% lidocaine with 1:100,000 epinephrine, on the day after extraction, if the patient has pain greater than or equal to 5 on 10 in their jaw-closer muscles (Numerical Pain rating scale).
• Placebo Comparator: Twin Block with sterile normal saline
  Following lower third molar extraction under intravenous sedation, the patient randomized to this arm with receive the Twin block using sterile normal saline, on the day after extraction, if the patient has pain greater than or equal to 5 on 10 in their jaw-closer muscles (Numerical Pain rating scale).

Primary Outcome Measure

Post-injection muscle pain [ Time Frame: 15 minutes ]

Central Contacts

• Gayathri Subramanian, PhD, DMD
  973 972 3418
  [email protected]
• Brahmleen Kaur, DMD
  973 972 3126
  [email protected]

Locations (1)

Find similar trials in Newark, NJ

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