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Analgesic

Naproxen for Osseointegrated Dental Implantation

Phase 4
Waitlist Available
Led By Elliot V Hersh, DMD, MS, PhD
Research Sponsored by Hersh, Elliot V., DMD, MS, PhD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject requires surgical placement of one or two (adjacent) dental implants
Males and females for 18-75 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 hours
Awards & highlights

Study Summary

This study is evaluating whether an over-the-counter painkiller may help reduce pain and inflammation following dental implant surgery.

Eligible Conditions
  • Osseointegrated Dental Implantation
  • Acute Pain

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
for restoration of function The person needs surgery to place one or two dental implants in order to restore function.
Select...
group were included in the study People aged 18-75 were studied, including males and females.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Interleukin 6 concentrations employing ELISA
Prostaglandin E2 concentrations employing liquid chromatography/mass spectrometry
Tumor necrosis factor concentrations employing ELISA
Secondary outcome measures
Pain
COX-1 activity
COX-2 activity
+2 more

Side effects data

From 2014 Phase 4 trial • 323 Patients • NCT01587274
6%
Nausea/ vomiting
5%
Stomach irritation
4%
Dizziness
4%
Drowsiness
3%
Other
100%
80%
60%
40%
20%
0%
Study treatment Arm
Naproxen Alone
Opioid
Skeletal Muscle Relaxant

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Naproxen sodiumExperimental Treatment2 Interventions
Naproxen sodium 440 mg followed by naproxen sodium 220 mg q 8h (max 660 mg/day)
Group II: AcetaminophenActive Control2 Interventions
Acetaminophen 1000 mg followed by acetaminophen 1000 mg q 6h (max 3000 mg/day according to Tylenol package insert)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Naproxen
FDA approved
Tramadol
FDA approved

Find a Location

Who is running the clinical trial?

Hersh, Elliot V., DMD, MS, PhDLead Sponsor
1 Previous Clinical Trials
28 Total Patients Enrolled
University of PennsylvaniaOTHER
1,998 Previous Clinical Trials
42,879,349 Total Patients Enrolled
Elliot V Hersh, DMD, MS, PhDPrincipal InvestigatorUniversity of Pennsylvania
3 Previous Clinical Trials
126 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Arkansas
Alabama
California
Other
How old are they?
< 18
18 - 65
What site did they apply to?
University of Pennsylvania
University of Pennsylvania School of Dental Medicine
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. University of Pennsylvania: < 24 hours
Average response time
  • < 1 Day
Recent research and studies
clinicaltrials.govStudy
OTC Naproxen and Acetaminophen Anti-Inflammatory Action in Dental Implant Patients
2021. "OTC Naproxen and Acetaminophen Anti-Inflammatory Action in Dental Implant Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04694300.
~8 spots leftby Apr 2025
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