Status:
COMPLETED
OTC Naproxen and Acetaminophen Anti-Inflammatory Action in Dental Implant Patients
Lead Sponsor:
Hersh, Elliot V., DMD, MS, PhD
Collaborating Sponsors:
University of Pennsylvania
Conditions:
Osseointegrated Dental Implantation
Pain, Acute
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
This double-blind pilot study will evaluate the anti-inflammatory and analgesic effects of an over-the-counter (OTC) regimen of naproxen sodium versus acetaminophen in patients receiving one or two (a...
Detailed Description
Placement of dental implants is a frequently performed outpatient surgical procedure, with United States dentists currently placing implants in approximately 500,000 patients per year.This procedure h...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Subject requires surgical placement of one or two (adjacent) dental implants
- Ability to read and sign informed consent
- Males and females for 18-75 years of age
- Non-smokers
- Negative urine drug screen
- Exclusion Criteria
- Advanced periodontal disease (\>20% Clinical Attachment Loss \>20% radiographic bone loss)
- History of bisphosphonate usage
- Medical history or medical condition that makes any of the study medications (naproxen sodium, acetaminophen, tramadol, etc.) inappropriate treatment options including any scheduled or recent cardiac procedures (within 6 months), a history of GI ulcers, liver or kidney disease, and anticoagulant or lithium intake.
- History of an allergic reaction to any pain reliever/fever reducer
- Contraindication to opioid use
- Positive urine drug screen for drugs of abuse unless on stable doses of a non-analgesic drug for a legitimate medical purpose
- Pregnancy - A urine pregnancy test will be performed immediately before the scheduled surgery on all women of child-bearing potential
- Local or systemic diseases that affects wound healing and inflammatory biomarkers (diabetes, autoimmune (rheumatoid arthritis), or inflammatory disorders - osteoarthritis is allowed).
- Smokers on this pilot study because it can affect levels of inflammatory biomarkers - a urine cotinine test will be performed immediately prior to the scheduled surgery on all subjects even if participant denies smoking history
- History of systemic steroid use over 2 weeks within last 2 years.
- Poor oral hygiene on a non-compliant individual.
Exclusion
Key Trial Info
Start Date :
February 7 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 28 2022
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04694300
Start Date
February 7 2021
End Date
August 28 2022
Last Update
May 16 2024
Active Locations (1)
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1
University of Pennsylvania School of Dental Medicine
Philadelphia, Pennsylvania, United States, 19104-6030