CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 30 enrolled
Drug / intervention
Naproxen +2 moredrug
Likely dose
Naproxen 440 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04694300
NCT04694300Phase 4Completed

Demonstration of OTC Naproxen Sodium's (Aleve's) Anti-inflammatory Action in Dental Implant Surgery Patients

Hersh, Elliot V., DMD, MS, PhD·interventional·Posted Jan 5, 2021·Updated May 16, 2024

In Brief

A Phase 4 clinical trial evaluating Naproxen, Acetaminophen, and 1 other intervention for Osseointegrated Dental Implantation and Pain, Acute. Completed, enrolled 30 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 4CompletedFinished
202120222023202420252026
First PostedJan 5, 2021
Enrollment StartFeb 7, 2021
Primary CompletionAug 28, 2022
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 5.5 years ago

Interventions

Naproxendrug

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.

Acetaminophendrug

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.

Tramadoldrug

50 mg by mouth every 6 hours as needed for pain