NCT04860141 Efficacy of Preoperative Administration of Gabapentin in 3rd Molar Dental Extraction.
| NCT ID | NCT04860141 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Loma Linda University |
| Condition | Dental Pain and Sensation Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 98 participants |
| Start Date | 2021-06-16 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 98 participants in total. It began in 2021-06-16 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study is a double-blind, randomized, prospective, placebo-controlled single-center clinical research study in which 600 mg of gabapentin or placebo will be administered 2 hours preoperatively to 49 patients each undergoing wisdom teeth extraction. We will measure intraoperative opioid use, severity of pain, the number of analgesics taken, and side effect profiles (e.g. nausea/vomiting, dizziness) at the following intervals, 4 hour, 8 hour, 12 hour, 24, and 72 hour post-procedure.
Eligibility Criteria
Inclusion Criteria: * Subjects must be at or older than 18. * Screened body mass index (BMI) between 18-35 kg/m2. * American Society of Anesthesiologists Classification I and II. * Subjects must be willing and able to comply with protocol requirements. * Subjects must be able to understand the informed consent and must be able to sign a written informed consent form prior to the initiation of any study procedures. * A subject must have at least 1 partial or fully impacted third molar tooth removal. Exclusion Criteria: * hypersensitivity to gabapentinoids; * history of chronic opioid or gabapentin usage (regular use of opioids \>3 months) * history of recreational drug usage * a history or clinical manifestations of significant metabolic, hematologic, pulmonary, cardiovascular, gastrointestinal, neurologic, hepatic, renal, urologic, musculoskeletal, psychiatric, or immunologic disorder, any acute, clinically significant illness or condition within 14 days prior to Day 1. * Patients with baseline pain. * Patients with any oral pathology will be excluded. * Pregnant or breastfeeding patients * An individual not legally competent to consent (e.g., incapacitated individuals, incompetents, minors)
Contact & Investigator
Chi Viet, DDS MD PhD
PRINCIPAL INVESTIGATOR
Loma Linda University
Frequently Asked Questions
Who can join the NCT04860141 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 59 Years, studying Dental Pain and Sensation Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04860141 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT04860141 currently recruiting?
Yes, NCT04860141 is actively recruiting participants. Contact the research team at jryu@llu.edu for enrollment information.
Where is the NCT04860141 trial being conducted?
This trial is being conducted at Loma Linda, United States.
Who is sponsoring the NCT04860141 clinical trial?
NCT04860141 is sponsored by Loma Linda University. The principal investigator is Chi Viet, DDS MD PhD at Loma Linda University. The trial plans to enroll 98 participants.