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Partial Responders for Impacted Wisdom Tooth

N/A
Waitlist Available
Led By Katherine N Theken, PharmD, PhD
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 7 days after third molar extraction
Awards & highlights

Summary

Nonsteroidal anti-inflammatory drugs (NSAIDs), like ibuprofen, are recommended as first-line treatment for post-surgical dental pain. However, there is variability in analgesic response, and some patients require supplemental opioids for adequate pain relief. The goal of this study is to identify the factors that contribute to the need for opioid after third molar extraction to help limit unnecessary opioid prescriptions in patients who will have good pain relief with ibuprofen alone.

Eligible Conditions
  • Impacted Wisdom Tooth
  • Acute Pain

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 7 days after third molar extraction
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 7 days after third molar extraction for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Supplemental Opioid Use
Secondary study objectives
COX-1 activity
COX-2 activity
Complete blood count with differential
+4 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Partial RespondersExperimental Treatment3 Interventions
Patients who require supplemental opioids (oxycodone 5 mg), in addition to ibuprofen 400 mg + acetaminophen 500 mg every 4 hours, for pain relief following third molar extraction
Group II: Complete RespondersExperimental Treatment2 Interventions
Patients who do not require supplemental opioids, in addition to ibuprofen 400 mg + acetaminophen 500 mg every 4 hours, for pain relief following third molar extraction
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ibuprofen 400 mg
2021
Completed Phase 4
~2000
OxyCODONE 5 mg Oral Tablet
2019
Completed Phase 4
~70

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor
2,053 Previous Clinical Trials
43,012,927 Total Patients Enrolled
National Institute of Dental and Craniofacial Research (NIDCR)NIH
302 Previous Clinical Trials
849,415 Total Patients Enrolled
Katherine N Theken, PharmD, PhDPrincipal InvestigatorUniversity of Pennsylvania
3 Previous Clinical Trials
132 Total Patients Enrolled
~133 spots leftby Sep 2027
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