NCT05919745 · Marquette University
Preemptive Ibuprofen Effects on Pain Perception Following Extraction and Bone Graft
What this study is about
The goal of this randomly assigned clinical trial is to compare patient-reported pain and taken by mouth 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.
View original scientific description
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.
Interventions
DRUG
Ibuprofen 600 mg
Preoperative delivery of ibuprofen per os.
DRUG
Placebo
Preoperative delivery of placebo per os.
DRUG
Acetaminophen
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.
Primary outcome measures
Difference in patient-reported postoperative pain between test and control group
Time frame: 1 hour following extraction and bone graft surgery
Visual Analogue Scale will be used to measure patient-reported pain. Its score range from 0-100 and the higher the score, the worse the reported pain is. Specifically, zero represents no pain and 100 represents the worst pain imaginable.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- 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
Where
- Milwaukee, Wisconsin
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 27, 2024 · Source of record for eligibility and locations