Patient Perception of Pain Following Extraction and Bone Graft Surgery With or Without Preemptive Ibuprofen: A Randomized Clinical Trial
Marquette University
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?
Description
The null hypothesis of this randomized clinical trial is that there is no difference in patient-reported pain and oral health-related quality of life during the first postoperative week following extraction and bone graft surgery between patients who received 600mg of preemptive ibuprofen versus placebo. Participants will receive ibuprofen 600mg (test group) or placebo (control group) per os 1 hour prior to extraction and bone graft surgery. Researchers and patients will be blinded to the group assignment. Both groups will be given rescue medication in the form of 1,000 mg tabs of acetaminoph…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- Yes
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…
Interventions
- DrugIbuprofen 600 mg
Preoperative delivery of ibuprofen per os.
- DrugPlacebo
Preoperative delivery of placebo per os.
- DrugAcetaminophen
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.
Location
- Marquette University School of Dentistry Graduate Periodontics ClinicMilwaukee, Wisconsin