NCT05335070 · Rutgers, The State University of New Jersey
Reducing Pain From Wisdom Molar Extractions
What this study is about
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 given through a vein (IV) sedation.
View original scientific description
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.
Interventions
DRUG
Temporo-masseteric Nerve Block
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
Primary outcome measures
Peak post-operative Pain Score
Time frame: up to 4 hours on day of procedure, post-procedure
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.
Mean Numerical Pain Rating Scale pain score
Time frame: One week
The average pain score reported by the patient during the entire post-operative week will be assessed
Passive Mouth opening
Time frame: Baseline, post-procedure (Day 1) and at post-operative visit (Day 8)
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
Masticatory muscle pain to palpation- Temporalis and Masseter
Time frame: Baseline, post-procedure (Day 1) and at post-operative visit (Day 8)
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
Total dose of pain medication- acetaminophen, ibuprofen and hydrocodone
Time frame: 8 Days
Total dose of pain medications consumed over the first post-operative week, for each of the medications will be recorded in mg
Adverse effects
Time frame: 8 days
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)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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)
- 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
Where
- Newark, New Jersey
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 5, 2025 · Source of record for eligibility and locations