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Gabapentin for Dental Pain

Phase 4
Recruiting
Led By Chi Viet, DDS MD PhD
Research Sponsored by Loma Linda University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
A subject must have at least 1 partial or fully impacted third molar tooth removal
Subjects must be at or older than 18
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during the surgical procedure
Awards & highlights

Study Summary

This trial is testing whether gabapentin can reduce pain and the need for painkillers after wisdom teeth removal.

Who is the study for?
This trial is for adults with a BMI of 18-35 who need at least one wisdom tooth removed. They should be generally healthy (ASA I or II), able to follow the study plan, and give informed consent. Excluded are those allergic to gabapentinoids, using opioids or gabapentin regularly, with a history of drug abuse, significant health issues, recent illness, oral pathology, pregnant/breastfeeding women, or unable to legally consent.Check my eligibility
What is being tested?
The study tests if taking Gabapentin (600mg) before wisdom teeth extraction reduces pain better than a placebo. It's randomized and double-blind meaning neither patients nor doctors know who gets the real medicine. Pain levels and side effects are tracked up to three days after surgery.See study design
What are the potential side effects?
Potential side effects from Gabapentin may include nausea/vomiting and dizziness. The severity of these side effects will be monitored at several time points after the dental procedure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I need to have at least one wisdom tooth removed.
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I am 18 years old or older.
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I am 18 years old or older.
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I need to have at least one wisdom tooth removed.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~72 hour postoperatively
This trial's timeline: 3 weeks for screening, Varies for treatment, and 72 hour postoperatively for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
intraoperative fentanyl use
Opioids
Secondary outcome measures
Dizziness
Drowsiness
Vomiting
+8 more

Side effects data

From 2018 Phase 4 trial • 121 Patients • NCT03080493
69%
Tiredness at 4 hours after dilator placement
63%
Tiredness at 2 hours after dilator placement
55%
Dizzines at 2 hours after dilator placement
40%
Dizziness at 4 hours after dilator placement
39%
Tiredness at 8 hours after dilator placement
35%
Dizziness at 5 minutes after dilator placement
30%
Tiredness at 18-24 hours after dilator placment
26%
Dizziness at 8 hours after dilator placement
12%
Tiredness at 5 minutes after dilator placement
12%
Tiredness at baseline
5%
Dizziness at 18-24 hours after dilator placement
2%
Dizziness at baseline
100%
80%
60%
40%
20%
0%
Study treatment Arm
Gabapentin
Placebo Oral Capsule

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Gabapentin groupExperimental Treatment1 Intervention
The patient in this group will take gabapentin 600mg PO 2 hours prior to his or her surgery.
Group II: Placebo groupPlacebo Group1 Intervention
The patient in this group will take a placebo that looks like gabapentin PO 2 hours prior to his or her surgery.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gabapentin 600mg
2017
Completed Phase 4
~250

Find a Location

Who is running the clinical trial?

Loma Linda UniversityLead Sponsor
304 Previous Clinical Trials
259,390 Total Patients Enrolled
Chi Viet, DDS MD PhDPrincipal InvestigatorLoma Linda University

Media Library

Gabapentin (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04860141 — Phase 4
Dental Pain and Sensation Disorder Research Study Groups: Gabapentin group, Placebo group
Dental Pain and Sensation Disorder Clinical Trial 2023: Gabapentin Highlights & Side Effects. Trial Name: NCT04860141 — Phase 4
Gabapentin (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04860141 — Phase 4
Dental Pain and Sensation Disorder Patient Testimony for trial: Trial Name: NCT04860141 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What criteria must potential participants meet to be eligible for this medical experiment?

"The criteria for enrolment in this trial is the presence of post-operative pain, a patient's age ranging between 18 and 59 years old. The research team seeks to recruit 98 participants."

Answered by AI

What is the ultimate intent of this medical experiment?

"Over a 72 hour postoperative period, the primary outcome of this clinical trial will be evaluated according to intraoperative fentanyl use. Secondary outcomes include pain interfering in normal work (scale 0-10), pain interfering in relations with other people (scale 0-10) and pain interfering in general activity (scale 0-10)."

Answered by AI

What ailments are commonly addressed by the administration of Gabapentin 600mg?

"Gabapentin 600mg is a successful therapeutic option for managing neuralgia, epilepsies and postherpetic neuralgia."

Answered by AI

To what extent has Gabapentin 600mg been tested in other clinical studies?

"At the moment, 25 studies revolving around Gabapentin 600mg are underway. Of these trials, 9 have reached Phase 3. The bulk of them are based in Columbus, Ohio but they span across 67 different locations globally."

Answered by AI

Are the elderly being admitted to this clinical experiment?

"This study is limited to participants aged between 18 and 59. For those outside this age range, there are 76 trials available for minors and 392 studies aimed at seniors."

Answered by AI

Does this experiment still accept participants?

"Affirmative. The clinicaltrial.gov record confirms that the study, which was initially published in June 2021, is presently recruiting participants; 98 people are needed from 1 medical facility."

Answered by AI

What is the participant recruitment rate for this research endeavor?

"Affirmative. Clinicaltrials.gov's data states that the investigation, which was first detailed on June 16th 2021, is still searching for participants. The trial requires 98 subjects to be enrolled at one facility."

Answered by AI

What are the potential hazards associated with Gabapentin 600mg?

"Taking into account the fact that this is a Phase 4 trial and has already been approved, our team at Power gave Gabapentin 600mg a rating of 3 in terms of safety."

Answered by AI

Who else is applying?

What state do they live in?
California
What site did they apply to?
Loma Linda University Health
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

Help others payment for study.
PatientReceived 1 prior treatment
Recent research and studies
~26 spots leftby Mar 2025