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Nonsteroidal Anti-inflammatory Drug

Celecoxib for Postoperative Pain

Phase 4
Waitlist Available
Led By Harry D Gilbert, DDS
Research Sponsored by The University of Texas Health Science Center, Houston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
American Society of Anesthesiologists (ASA) physical status classification 1 or 2
At least 1 impacted mandibular third molar planned for extraction
Must not have
Severe pericoronitis associated with third molar to be extracted
History of cardiovascular or cerebrovascular disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up any time during the 72 hours after procedure
Awards & highlights
All Individual Drugs Already Approved
Approved for 10 Other Conditions
Drug Has Already Been Approved
Pivotal Trial

Summary

This trial will compare the effects of two different drugs on post-operative pain after impacted third molar surgery.

Who is the study for?
This trial is for healthy individuals with an impacted mandibular third molar (wisdom tooth) that needs extraction. They should not have allergies to NSAIDs, aspirin, acetaminophen, or sulfa drugs; no history of heart or brain blood vessel disease; not pregnant; and without severe dental infection or liver problems.
What is being tested?
The study tests the effectiveness in managing pain after wisdom tooth surgery using Celecoxib alone versus a combination of Celecoxib and Acetaminophen. Participants will receive these medications preemptively. A placebo group is also included for comparison.
What are the potential side effects?
Celecoxib may cause stomach upset, headache, dizziness, and increased risk of bleeding. Acetaminophen can lead to nausea or liver damage if used excessively. Side effects vary among individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am in good or mild systemic disease state according to ASA.
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I am planning 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 have severe gum infection around my wisdom tooth that needs removal.
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I have a history of heart or stroke-related issues.
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I have liver disease or a condition affecting my liver.

Timeline

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Pain as Assessed by a Visual Analogue Scale (VAS)
Secondary study objectives
Number of Participants Who Receive an Emergency Analgesic Intervention
Pain as Assessed by a Categorical Descriptive Questionnaire

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
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
Active Control
Placebo Group
Group I: Celecoxib plus AcetaminophenActive Control2 Interventions
Single oral dose of celecoxib 200 mg in combination with acetaminophen 1000 mg 30 to 60 minutes prior to the dental procedure.
Group II: Celecoxib plus PlaceboPlacebo Group2 Interventions
Single oral dose of celecoxib 200 mg with placebo 30 to 60 minutes prior to the dental procedure

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonLead Sponsor
945 Previous Clinical Trials
344,444 Total Patients Enrolled
5 Trials studying Postoperative Pain
657 Patients Enrolled for Postoperative Pain
Harry D Gilbert, DDSPrincipal InvestigatorUniversity of Texas School of Dentistry at Houston
Auco DangStudy DirectorUniversity of Texas School of Dentistry at Houston

Media Library

Celecoxib (Nonsteroidal Anti-inflammatory Drug) Clinical Trial Eligibility Overview. Trial Name: NCT04790812 — Phase 4
Postoperative Pain Research Study Groups: Celecoxib plus Placebo, Celecoxib plus Acetaminophen
Postoperative Pain Clinical Trial 2023: Celecoxib Highlights & Side Effects. Trial Name: NCT04790812 — Phase 4
Celecoxib (Nonsteroidal Anti-inflammatory Drug) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04790812 — Phase 4
~14 spots leftby Nov 2025
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