Reducing Pain From Wisdom Molar Extractions

NCT05335070 | Recruiting Phase 2 FDA Drug

• 1 other identifier: Pro2021002543
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Pain

Keywords

Temporo-masseteric Nerve Block; Twin Block; Prescription opioids; Acute Post-extraction pain

Outcome Measures

Primary Outcomes (6)

• Peak post-operative Pain Score

  Every 30 minutes, the patient's pain score (Numerical Pain Rating Scale with scores from 0-10, (the NRS scale), with 0= no pain, 1-3= mild pain, 4-6= moderate pain, 7-10= severe pain) will be recorded to document peak pain score by hour 4. If the patient were to report a score from 7-10 at any time, no additional delay/pain score enquiry will take place and the patient will be directed to take the first dose of post-operative pain medication as described elsewhere.

  up to 4 hours on day of procedure, post-procedure

• Mean Numerical Pain Rating Scale pain score

  The average pain score reported by the patient during the entire post-operative week will be assessed

  One week

• Passive Mouth opening

  Passive mouth opening will be measured (in mm) at baseline, post-procedure before as well as 15 min after TMNB injection and finally, during the post-operative visit (Day 8) will be measured

  Baseline, post-procedure (Day 1) and at post-operative visit (Day 8)

• Masticatory muscle pain to palpation- Temporalis and Masseter

  Numerical pain rating scale pain scores reported by the patient upon palpation of the masseter and temporalis muscles will be recorded at baseline, post-procedure (before and 15 min after TMNB injection) and at the post-operative visit one week after procedure

  Baseline, post-procedure (Day 1) and at post-operative visit (Day 8)

• Total dose of pain medication- acetaminophen, ibuprofen and hydrocodone

  Total dose of pain medications consumed over the first post-operative week, for each of the medications will be recorded in mg

  8 Days

• Adverse effects

  The patient will be queried each day for any adverse effects from pain medications and any adverse effects at the site of injection (infection, pain etc)

  8 days

Study Arms (1)

Temporo-masseteric Nerve Block (TMNB) Injection with Local Anesthetic

EXPERIMENTAL

Following lower third molar extraction under intravenous sedation, the patient will receive the TMNB local anesthetic nerve block using the standard dental local anesthetic, i.e,. 2% lidocaine with 1:100,000 epinephrine, on the side/s of lower wisdom molar extraction/s

Drug: Temporo-masseteric Nerve Block

Interventions

Temporo-masseteric Nerve Block DRUG

Following lower third molar extraction under intravenous sedation, the patient will receive the TMNB local anesthetic nerve block using the standard dental local anesthetic, i.e,. 2% lidocaine with 1:100,000 epinephrine on the side/s of the lower wisdom molar (third molar) extraction/s

Temporo-masseteric Nerve Block (TMNB) Injection with Local Anesthetic

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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/absence of pain

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Sites (1)

The University Hospital- Dental Clinic

Newark, New Jersey, 07103, United States

RECRUITING

Related Publications (3)

• Quek SYP, Gomes-Zagury J, Subramanian G. Twin Block in Myogenous Orofacial Pain: Applied Anatomy, Technique Update, and Safety. Anesth Prog. 2020 Jun 1;67(2):103-106. doi: 10.2344/anpr-67-01-03.

  PMID: 32633773 BACKGROUND

• Kanti V, Ananthan S, Subramanian G, Quek SYP. Efficacy of the twin block, a peripheral nerve block for the management of chronic masticatory myofascial pain: A case series. Quintessence Int. 2017 Oct 6:725-729. doi: 10.3290/j.qi.a39094. Online ahead of print.

  PMID: 28990015 BACKGROUND

• Quek S, Young A, Subramanian G. The twin block: a simple technique to block both the masseteric and the anterior deep temporal nerves with one anesthetic injection. Oral Surg Oral Med Oral Pathol Oral Radiol. 2014 Sep;118(3):e65-7. doi: 10.1016/j.oooo.2014.01.227. Epub 2014 Feb 6.

  PMID: 24703404 BACKGROUND

MeSH Terms

Conditions

Acute Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Gayathri D Subramanian, PhD, DMD

  Rutgers School of Dental Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gayathri Subramanian, PhD, DMD

CONTACT

9739723418; subramga@sdm.rutgers.edu

Samuel YP Quek, DMD, MPH

CONTACT

732 570 1996

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Prospective single-arm pilot study

Study Record Dates

• First Submitted: April 13, 2022
• First Posted: April 19, 2022
• Study Start: September 13, 2022
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 5, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After study completion, upon review of request
• Access Criteria: A written request will be evaluated and responded to.

Locations

US (1)