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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
Must not have
Patients with any oral pathology will be excluded
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during the surgical procedure
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have any mouth diseases.
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I have not had a serious illness or condition in the last 14 days.
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I have been using opioids or gabapentin regularly for more than 3 months.
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I am legally able to give consent for medical treatment.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
intraoperative fentanyl use
Opioids
Secondary study objectives
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 baseline
12%
Tiredness at 5 minutes after dilator placement
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

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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
316 Previous Clinical Trials
266,602 Total Patients Enrolled
1 Trials studying Infections
1,100 Patients Enrolled for Infections
Chi Viet, DDS MD PhDPrincipal InvestigatorLoma Linda University

Media Library

Gabapentin (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04860141 — Phase 4
Infections Research Study Groups: Gabapentin group, Placebo group
Infections 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
Infections Patient Testimony for trial: Trial Name: NCT04860141 — Phase 4
~7 spots leftby Mar 2025
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