Recruiting

Phase 2

Pain ReliefReducing Pain From Wisdom Molar Extractions

Sponsor:

Rutgers, The State University of New Jersey

Code:

NCT05335070

Conditions

Acute Pain

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Not accepted

Interventions

Temporo-masseteric Nerve Block

Study Details

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

Study ID

NCT05335070

Start date

Sep 13, 2022

Status verified date

Dec, 2025

Completion date

Dec, 2026

Anticipated

Primary completion date

Nov, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Design

Enrollment

20 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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

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

Interventions

Temporo-masseteric Nerve Block

Primary outcome measure

Peak post-operative Pain Score [ Time Frame: up to 4 hours on day of procedure, post-procedure ]
Mean Numerical Pain Rating Scale pain score [ Time Frame: One week ]
Passive Mouth opening [ Time Frame: Baseline, post-procedure (Day 1) and at post-operative visit (Day 8) ]
Masticatory muscle pain to palpation- Temporalis and Masseter [ Time Frame: Baseline, post-procedure (Day 1) and at post-operative visit (Day 8) ]
Total dose of pain medication- acetaminophen, ibuprofen and hydrocodone [ Time Frame: 8 Days ]
Adverse effects [ Time Frame: 8 days ]

Central Contacts and Locations

Central contacts

Gayathri Subramanian, PhD, DMD

9739723418 subramga@sdm.rutgers.edu

Samuel YP Quek, DMD, MPH

732 570 1996

Locations

The University Hospital- Dental Clinic

Recruiting

Newark, New Jersey, United States, 07103

Contacts

Gayathri Subramanian

973-972-3418 subramga@sdm.rutgers.edu

More Information

Sponsor

Rutgers, The State University of New Jersey

Last update posted

Dec 5, 2025

Last verified

Dec, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Rutgers, The State University of New Jersey on 2025-12-05.