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New treatment option for Pain, Post Operative
Official title Preemptive Ibuprofen Effects on Pain Perception Following Extraction and Bone Graft
ClinicalTrials.gov ID: NCT05919745
What this study is testing
What is Ibuprofen 600 mg?
Ibuprofen 600 mg is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for pain, post operative.
Also referred to as Test.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- Age \>18 years
- Good general health (controlled conditions)
- Fluent in English
- Treatment-planned for single site extraction and bone graft surgery
You likely can't join if
- 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.)
See the full eligibility criteria
- Age \>18 years
- Good general health (controlled conditions)
- Fluent in English
- Treatment-planned for single site extraction and bone graft surgery
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Milwaukee, Wisconsin, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Milwaukee, Wisconsin, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.