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

NCT04694300 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-05-16

Study results available
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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.

Conditions

  • Osseointegrated Dental Implantation
  • Pain, Acute

Interventions

DRUG

Naproxen

440 mg by mouth immediately after completion of implant surgery followed by 220 mg 12 hours later. Then 220 mg every 8 hours for the next two days.

DRUG

Acetaminophen

1000 mg by mouth immediately after the completion of implant surgery followed by 1000 mg every 6 hours for 3 days after surgery with a maximum daily dose of 3000 mg.

DRUG

Tramadol

50 mg by mouth every 6 hours as needed for pain

Sponsors & Collaborators

Principal Investigators

  • Elliot V Hersh, DMD, MS, PhD · University of Pennsylvania

  • Katherine N Theken, PharmD, PhD · University of Pennsylvania School of Dental Medicine and Medicine

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-07
Primary Completion
2022-08-28
Completion
2022-08-28
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04694300 on ClinicalTrials.gov