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OTC Naproxen and Acetaminophen Anti-Inflammatory Action in Dental Implant Patients
NCT04694300 · View on ClinicalTrials.gov ↗
Study 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 Studied
Interventions
- DRUG Acetaminophen
- DRUG Naproxen
- DRUG Tramadol
Study Locations (1)
Pennsylvania
- University of Pennsylvania School of Dental Medicine — Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2021-02-07 |
| Est. Completion | 2022-08-28 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04694300
The ClinicalTrials.gov registry entry for NCT04694300 describes a study currently listed as completed. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hersh, Elliot V., DMD, MS, PhD, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Pain, Acute appearing as the primary indexed condition, and to 3 interventions — of which Acetaminophen is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04694300 reports 1 study location spanning 1 distinct geographic area — top geographies include Pennsylvania. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04694300 about?
NCT04694300 is a clinical study titled "OTC Naproxen and Acetaminophen Anti-Inflammatory Action in Dental Implant Patients". 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 goo...
What is the current status of trial NCT04694300?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 30 participants. The study started on 2021-02-07. Estimated completion is 2022-08-28.
What conditions does trial NCT04694300 study?
This clinical trial studies the following conditions: Pain, Acute, Osseointegrated Dental Implantation. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04694300?
The interventions under investigation include: Acetaminophen (DRUG), Naproxen (DRUG), Tramadol (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04694300?
This trial is sponsored by Hersh, Elliot V., DMD, MS, PhD, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04694300 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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