Preemptive Ibuprofen Effects on Pain Perception Following Extraction and Bone Graft

Part of paid clinical trials in Milwaukee, Wisconsin.

Sponsor
Marquette University
Study ID
NCT05919745
Phase
PHASE4
Status
Recruiting
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Conditions

  • Pain, Post Operative
  • Quality of Life

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Ibuprofen 600 mg — DRUG
    Preoperative delivery of ibuprofen per os.
  • Placebo — DRUG
    Preoperative delivery of placebo per os.
  • Acetaminophen — DRUG
    Both groups will be given rescue medication in the form of 1,000 mg tabs of acetaminophen every 6 hours per os as needed for pain (maximum allowed daily dose 4,000 mg per FDA) and will be allowed to receive ibuprofen or other analgesic medication as needed if pain is not controlled by acetaminophen alone. The subjects will receive the rescue medication pills at the end of the surgical appointment.

Study Details

The goal of this randomized clinical trial is to compare patient-reported pain and oral health-related quality of life during the first postoperative week following extraction and bone graft surgery in patients who received preemptive ibuprofen versus placebo. Participants will receive ibuprofen 600mg or placebo by mouth with water 1 hour prior to extraction and bone graft surgery. The primary question it aims to answer is: • Does preemptive ibuprofen have an effect on postoperative pain 1 hour following extraction and bone graft surgery compared to placebo? Secondary questions are: * Does preemptive ibuprofen have an effect on pain during the first 3 postoperative hours and 7 postoperative days following extraction and bone graft surgery compared to placebo? * Does preemptive ibuprofen have an effect on oral health-related quality of life during the 7 postoperative days following extraction and bone graft surgery compared to placebo?

Key Dates

Start date
Oct 19, 2023
Status verified
Sep 2024
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Ibuprofen group or Test Group
    Subjects will be given ibuprofen 600mg tab 1h prior to surgery.
  • Placebo Comparator: Placebo group or Control group
    Subjects will be given a placebo tab 1h prior to surgery.

Primary Outcome Measure

Difference in patient-reported postoperative pain between test and control group [ Time Frame: 1 hour following extraction and bone graft surgery ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Marquette University School of Dentistry Graduate Periodontics ClinicMilwaukeeWisconsin53233
Vrisiis Kofina, DDS, MS
[email protected]
4142886521
Arndt Guentsch, DMD, PhD, MHBA, MS
[email protected]
4142886089
Vrisiis Kofina, DDS, MS (PRINCIPAL_INVESTIGATOR)

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By research site
Marquette University School of Dentistry Graduate Periodontics Clinic· Milwaukee, WI

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