Twin Block, Pain Medications and Third Molar Extractions

NCT04880707 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: Pro2020002007
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Twin block; Prescription opioids; Acute post-extraction pain

Outcome Measures

Primary Outcomes (3)

• Post-injection muscle pain

  NRS pain scores before and 15 min after Twin block administration on day after procedure

  15 minutes

• Mean NRS pain score

  Means NRS pain score by Day, comparing placebo and Twin block groups

  one week

• Total prescription opioid consumption

  Comparison of total prescription opioid consumption (mg) between placebo and Twin block groups

  one week

Secondary Outcomes (2)

• Passive mouth opening

  15 min

• Passive mouth opening

  one week

Study Arms (2)

Twin Block with Local Anesthetic

ACTIVE COMPARATOR

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).

Drug: Twin block local anesthetic nerve block using standard dental anesthetic

Twin Block with sterile normal saline

PLACEBO COMPARATOR

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).

Other: Twin block with placebo

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 Local Anesthetic

Twin block with placebo OTHER

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

Twin Block with sterile normal saline

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: As reported by participant
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients requiring extraction/s of at least 1 lower wisdom (third) molar that is partially/fully 'impacted', under intravenous sedation, are eligible to participate in this study so long as they
• are older than 18 years of age,
• are healthy,
• have no cognitive/intellectual disability,
• have no past/recent pain or reduced range of motion in their jaw joint/ muscle complex, no trauma or surgery in their jaw region.
• have an electronic device such as a smart phone or a tablet/ computer with internet connection.
• are willing to participate in the study and not be excluded by the following criteria below.

You may not qualify if:

• Any patients, even if satisfying the criteria above, may not take part if they have any of the following:
• Compromised ability to guard their self-interest, for e.g., prisoners, children, pregnant women, patients with intellectual/cognitive disability are not enrolled in the study.
• Those patients who present with infection/inflammation involving the third molars slated for extractions, on the day of their procedure, may not take part in the study.
• In addition, those who have had opioid pain medication/s in the past to address short-term or long-standing pain, or those who are on long term prescription of anti-inflammatory pain medication, are unable to participate.
• Those with long standing pain of the jaw joint or muscles.
• Finally, those patients who are allergic to/unable to tolerate either the dental local anesthetic or its components, opioids, acetaminophen ('Tylenol') or ibuprofen ('Motrin' or 'Advil') also may not take part in the study.

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• New Jersey Health Foundation: collaborator

Study Sites (1)

Rutgers School of Dental Medicine

Newark, New Jersey, 07103, United States

RECRUITING

Related Publications (3)

• 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

• 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 RESULT

• 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 RESULT

MeSH Terms

Conditions

Acute Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Gayathri Subramanian, PhD, DMD

  Rutgers School of Dental Medicine, Newark NJ

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gayathri Subramanian, PhD, DMD

CONTACT

973 972 3418; subramga@sdm.rutgers.edu

Brahmleen Kaur, DMD

CONTACT

973 972 3126; bk466@sdm.rutgers.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The patient, Twin block administrator and assessor assessing jaw muscle pain will all be unaware of whether the patient received sterile saline (placebo) or local anesthetic in the Twin Block injection.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Triple blind, randomized prospective pilot study comparing post wisdom molar extraction pain comparing placebo or Twin block local anesthetic nerve block injection

Study Record Dates

• First Submitted: May 5, 2021
• First Posted: May 11, 2021
• Study Start: March 11, 2024
• Primary Completion: February 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: October 7, 2025

Record last verified: 2025-10

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)