Recruiting
Phase 2

Twin Block with Pain Medications

Sponsor:

Rutgers, The State University of New Jersey

Code:

NCT04880707

Conditions

Acute Pain

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Twin block local anesthetic nerve block using standard dental anesthetic

Twin block with placebo

Study Details

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

Study ID

NCT04880707

Start date

Mar 11, 2024

Status verified date

Jun, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Aug, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

1. are older than 18 years of age,
2. are healthy,
3. have no cognitive/intellectual disability,
4. have no past/recent pain or reduced range of motion in their jaw joint/ muscle complex, no trauma or surgery in their jaw region.
5. have an electronic device such as a smart phone or a tablet/ computer with internet connection.
6. are willing to participate in the study and not be excluded by the following criteria below.

Exclusion Criteria:

  • Any patients, even if satisfying the criteria above, may not take part if they have any of the following:

1. 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.
2. 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.
3. 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.
4. Those with long standing pain of the jaw joint or muscles.
5. 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.

Study Design

Enrollment

48 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

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).

Interventions

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.

Twin block with placebo

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

Primary outcome measure

  • Post-injection muscle pain [ Time Frame: 15 minutes ]
  • Mean NRS pain score [ Time Frame: one week ]
  • Total prescription opioid consumption [ Time Frame: one week ]

Central Contacts and Locations

Central contacts

Gayathri Subramanian, PhD, DMD

973 972 3418subramga@sdm.rutgers.edu

Brahmleen Kaur, DMD

973 972 3126bk466@sdm.rutgers.edu

Locations

Rutgers School of Dental Medicine

Recruiting

Newark, New Jersey, United States, 07103

Contacts

Gayathri Subramanian, PhD, DMD

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

More Information

Sponsor

Rutgers, The State University of New Jersey

Last update posted

Jun 22, 2026

Last verified

Jun, 2026

Keywords

  • 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 2026-06-22.