200 Participants Needed

Ibuprofen for Pain After Wisdom Tooth Extraction

SS
Overseen ByStacey Secreto
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of ibuprofen for dental pain following wisdom teeth removal. Some individuals require additional pain relief with opioids, and the study aims to determine the reasons. This could help doctors avoid prescribing opioids when ibuprofen alone suffices. Ideal participants are those undergoing wisdom tooth removal, experiencing moderate pain post-surgery, and having no major health issues.

As a Phase 2 trial, this research measures ibuprofen's effectiveness in an initial, smaller group, offering participants the opportunity to contribute to important findings that could enhance pain management strategies.

Do I have to stop taking my current medications for the trial?

The trial requires you to stop taking certain medications, like pain relievers and sedatives, 24 hours before the surgery. However, hormonal contraceptives, hormone replacement therapy, and thyroid replacement hormones are allowed. Other stable medications may be allowed if the investigator agrees.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that taking ibuprofen and acetaminophen together is safe and effective for pain relief after dental surgery, such as wisdom teeth removal. Studies have found that this combination manages pain better than some opioid treatments, particularly in the first few days post-surgery. Patients report experiencing less pain and improved sleep with these medications.

Both ibuprofen and acetaminophen are commonly used and trusted for dental pain. A recent study involving over 1,800 patients found this combination effectively reduced pain and improved sleep. While all medications can have side effects, this combination maintains a strong safety record for those recovering from dental procedures.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to understand why some people need extra pain relief after wisdom tooth removal, even when taking ibuprofen and acetaminophen. This trial is unique as it explores how different patients respond to the same pain medication combination, potentially identifying why some require additional opioids while others don't. By uncovering these differences, the trial could lead to more personalized pain management strategies, reducing the need for opioids and enhancing patient comfort.

What evidence suggests that this trial's treatments could be effective for post-surgical dental pain?

Research has shown that taking ibuprofen with acetaminophen effectively reduces pain after dental surgeries like wisdom tooth removal. One study found that a single dose of 400 mg of ibuprofen eased pain after these procedures. Another large study with over 1,800 participants demonstrated that this combination relieved pain better than opioids, which are strong painkillers. Additionally, using these two over-the-counter (OTC) medications together usually causes fewer side effects than using opioids. In this trial, some participants, labeled as "Complete Responders," will manage their pain with just ibuprofen and acetaminophen, while others, labeled as "Partial Responders," may require supplemental opioids. Overall, this suggests that most patients can manage dental pain effectively without needing stronger medications.26789

Who Is on the Research Team?

KN

Katherine N Theken, PharmD, PhD

Principal Investigator

University of Pennsylvania

Are You a Good Fit for This Trial?

Inclusion Criteria

I have signed and dated the consent form.
I am willing and able to follow the study rules and attend all appointments.
I can take pills and will follow the treatment plan.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive ibuprofen 400 mg + acetaminophen 500 mg every 4 hours, with supplemental opioids as needed, following third molar extraction

1 day
1 visit (in-person)

Follow-up

Participants are monitored for pain intensity, supplemental opioid use, and various biological assessments

7 days
1 visit (in-person), daily monitoring

What Are the Treatments Tested in This Trial?

Interventions

  • Ibuprofen

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Partial RespondersExperimental Treatment3 Interventions
Group II: Complete RespondersExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials
2,118
Recruited
45,270,000+

National Institute of Dental and Craniofacial Research (NIDCR)

Collaborator

Trials
312
Recruited
853,000+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/34850186/

Pain Relief with Combination Acetaminophen/Codeine or ...

Conclusions: Our data indicate that single dose of ibuprofen (400 mg) is an effective pain reducer for post third molar extraction pain.

Non-Opioid Pain Relievers Beat Opioids After Dental Surgery

The trial in more than 1,800 patients found that those given a combination of ibuprofen and acetaminophen experienced less pain, better sleep ...

Combining ibuprofen and acetaminophen for acute pain ...

The results of the quantitative systematic reviews indicated that the ibuprofen-APAP combination may be a more effective analgesic, with fewer untoward effects, ...

New Study Finds OTC Pain Relievers Outperform Opioids

A combination of over-the-counter pain relievers is more effective than opioids in managing pain after wisdom tooth extractions.

What's the Best Pain Relief after a Tooth Extraction?

Ibuprofen taken in combination with acetaminophen is the most effective way to ease dental pain. In fact, in most cases, the combination of the two is more ...

Ibuprofen and/or paracetamol (acetaminophen) for pain relief ...

Both paracetamol and ibuprofen are commonly used analgesics for the relief of pain following the surgical removal of lower wisdom teeth (third molars).

Pain control following impacted mandibular third molar ...

The findings of this study show that the combination of Paracetamol and Ibuprofen are well-tolerated and effective option for post operative pain after ...

Nonopioid vs opioid analgesics after impacted third-molar ...

The ibuprofen and acetaminophen combination managed pain better for the first 2 days and led to greater satisfaction over the entire postoperative period.

Non-opioid pain relief proven more effective after wisdom ...

The trial in more than 1,800 patients found that those given a combination of ibuprofen and acetaminophen experienced less pain, better sleep ...