RECRUITING

Twin Block, Pain Medications and Third Molar Extractions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Myogenous Face Pain Following Third Molar Extractions Under Intravenous Sedation

Quick Facts

Study Start:2024-03-11
Study Completion:2026-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04880707

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. 1. are older than 18 years of age,
  3. 2. are healthy,
  4. 3. have no cognitive/intellectual disability,
  5. 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.
  6. 5. have an electronic device such as a smart phone or a tablet/ computer with internet connection.
  7. 6. are willing to participate in the study and not be excluded by the following criteria below.
  1. * Any patients, even if satisfying the criteria above, may not take part if they have any of the following:
  2. 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.
  3. 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.
  4. 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.
  5. 4. Those with long standing pain of the jaw joint or muscles.
  6. 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.

Contacts and Locations

Study Contact

Gayathri Subramanian, PhD, DMD
CONTACT
973 972 3418
subramga@sdm.rutgers.edu
Brahmleen Kaur, DMD
CONTACT
973 972 3126
bk466@sdm.rutgers.edu

Principal Investigator

Gayathri Subramanian, PhD, DMD
PRINCIPAL_INVESTIGATOR
Rutgers School of Dental Medicine, Newark NJ

Study Locations (Sites)

Rutgers School of Dental Medicine
Newark, New Jersey, 07103
United States

Collaborators and Investigators

Sponsor: Rutgers, The State University of New Jersey

  • Gayathri Subramanian, PhD, DMD, PRINCIPAL_INVESTIGATOR, Rutgers School of Dental Medicine, Newark NJ

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-11
Study Completion Date2026-03

Study Record Updates

Study Start Date2024-03-11
Study Completion Date2026-03

Terms related to this study

Keywords Provided by Researchers

  • Twin block
  • Prescription opioids
  • Acute post-extraction pain

Additional Relevant MeSH Terms

  • Acute Pain