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.