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NCT04694300 · ClinicalTrials.gov registry record · Phase 4
OTC Naproxen and Acetaminophen Anti-Inflammatory Action in Dental Implant Patients
A Phase 4 study of Pain, Acute and Osseointegrated Dental Implantation, sponsored by Hersh, Elliot V., DMD, MS, PhD.
- Completed
- Registry status
- Phase 4
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT04694300: Completed Phase 4 study of Pain, Acute and Osseointegrated Dental Implantation, sponsored by Hersh, Elliot V., DMD, MS, PhD.
NCT04694300 is a Phase 4 study of Pain, Acute and Osseointegrated Dental Implantation that has completed, run by Hersh, Elliot V., DMD, MS, PhD. The registered enrollment target is 30 participants, below the 101-participant average among 31 other Pain, Acute trials with a reported enrollment target (70% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04694300, a Phase 4 study of Pain, Acute and Osseointegrated Dental Implantation, has completed, sponsored by Hersh, Elliot V., DMD, MS, PhD.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
Median maximum pain intensity scores where 0 = no pain and 10 = worst possible pain
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 |
What the finished NCT04694300 record still lists
NCT04694300 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 101-participant average among 31 other Pain, Acute trials with a reported enrollment target (70% lower).
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.
NCT04694300 reports a single indexed study location in Pennsylvania.
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.
What interventions are being tested in trial NCT04694300?
The interventions under investigation include: Acetaminophen (DRUG), Naproxen (DRUG), Tramadol (DRUG).
Who is sponsoring clinical trial NCT04694300?
This trial is sponsored by Hersh, Elliot V., DMD, MS, PhD, which has 2 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT04694300's enrollment target sits among peer trials
30 28th of 31 higher than 3 of 31 other Pain, Acute trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pain, Acute trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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