A Randomized, Double-Blind Trial of the Analgesic and Anti-Inflammatory Effects of Naproxen Sodium and Acetaminophen Following Implant Placement Surgery

Abstract

Objectives: The objectives of this study were to compare the analgesic and anti-inflammatory effects of naproxen sodium and acetaminophen after implant placement surgery. Materials and Methods: Adult patients who received one or two dental implants were treated with naproxen sodium (440 mg loading dose + 220 mg q8h, n=15) or acetaminophen (1000 mg q6h - max daily dose 3000 mg, n=15) for three days after implant placement in a randomized, double-blind design. Pain was assessed on a 0-10 scale every 20 minutes for 6 h. Tramadol (50 mg) was available as a rescue medication. Plasma and gingival crevicular fluid (GCF) were collected prior to the surgery and 0, 1, 2, 4, 6, 24, and 72h after surgery for quantification of interleukin (IL)-6, IL-8, and IL-1β levels. Results: Pain scores were significantly lower in patients treated with naproxen sodium compared to those treated with acetaminophen. Inflammatory mediator levels in plasma and GCF increased after surgery and returned to near baseline levels by 72h. Plasma IL-6 levels were significantly lower 6h after surgery in patients treated with naproxen sodium compared to acetaminophen. No differences in inflammatory mediator concentrations in GCF were observed between the treatment groups. Conclusions: Naproxen sodium was more effective than acetaminophen in reducing post-operative pain and systemic inflammation following surgical placement of one or two dental implants. Further studies are needed to determine whether these findings are applicable to more complex implant cases and how they affect clinical outcomes following implant placement.

Competing Interest Statement

K.N.T., Y.C.C., J.M.K., C.H.M. and E.V.H. received research support from Bayer Health Care LLC. The other authors have no competing interests to disclose.

Clinical Trial

NCT04694300

Funding Statement

This study was supported by an investigator-initiated research grant from Bayer Health Care LLC. The funder had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

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The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

The IRB of the University of Pennsylvania gave ethical approval for this work.

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Data Availability

All data produced in the present study are available upon reasonable request to the authors.

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