Preemptive Ibuprofen Effects on Pain Perception Following Extraction and Bone Graft

• Status: Not yet recruiting
• Trial end date: 2026-12-01
• Target enrollment: 0
• Participant gender: All

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?

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Marquette University
• Treatments: Acetaminophen; Ibuprofen

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