Overview

OTC Naproxen and Acetaminophen Anti-Inflammatory Action in Dental Implant Patients

Status:
Recruiting
Trial end date:
2022-04-06
Target enrollment:
0
Participant gender:
All
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 (adjacent) dental implants. It will also confirm that naproxen sodium in the OTC dosage range is a good alternative to immediate-release opioid formulations, which are subject to misuse, abuse and diversion in this patient population.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Hersh, Elliot V., DMD, MS, PhD
Collaborators:
Bayer
University of Pennsylvania
Treatments:
Acetaminophen
Naproxen
Tramadol
Criteria
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.