NCT05919745 Preemptive Ibuprofen Effects on Pain Perception Following Extraction and Bone Graft
| NCT ID | NCT05919745 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Marquette University |
| Condition | Pain, Post Operative |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2023-10-19 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 50 participants in total. It began in 2023-10-19 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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?
Eligibility Criteria
Inclusion Criteria * Age \>18 years * Good general health (controlled conditions) * Fluent in English * Treatment-planned for single site extraction and bone graft surgery Exclusion criteria * Pregnancy * Site with active infection i.e purulence, abscess formation * Patients experiencing pain pre-operatively * Oral surgery in more than one site/quadrant in the same session * Patients receiving surgery under sedation * Patients with any contraindication for oral bone grafting surgery (e.g., on anticoagulants, medication-related osteonecrosis of the jaw, etc.) * Patients experiencing acute or chronic oral pain due to conditions or previous interventions * Patients with diseases or taking medications that affect hard and soft tissue wound healing such as poorly controlled diabetes, bisphosphonate use, corticosteroid use, chemotherapy, immunosuppressive therapy, etc. * Current or chronic (≥4 weeks) use of anti-inflammatory, analgesic, corticosteroid or sedative medications in the past 6 months * Health conditions that contraindicate the use of NSAIDs, such as stomach ulcers, bleeding disorders, renal disfunction, liver cirrhosis or acute liver disease, etc. * Intake of medications that interact with NSAIDs or whose actions can be affected by NSAIDs, such as anticoagulant/antiplatelet medications, ACE inhibitors, diuretics, etc. * Allergy to ibuprofen, acetaminophen and/or aspirin, and study materials (e.g., sutures, grafts, membranes?). * Patients having 3 or more alcoholic beverages daily * Patients who are planned to undergo heart surgery or had heart surgery less than 6 months prior * Not fluent in English
Contact & Investigator
Vrisiis Kofina, DDS, MS
PRINCIPAL INVESTIGATOR
Marquette University
Frequently Asked Questions
Who can join the NCT05919745 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pain, Post Operative. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05919745 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05919745 currently recruiting?
Yes, NCT05919745 is actively recruiting participants. Contact the research team at vrisiis.kofina@marquette.edu for enrollment information.
Where is the NCT05919745 trial being conducted?
This trial is being conducted at Milwaukee, United States.
Who is sponsoring the NCT05919745 clinical trial?
NCT05919745 is sponsored by Marquette University. The principal investigator is Vrisiis Kofina, DDS, MS at Marquette University. The trial plans to enroll 50 participants.