Clinical trial

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

Name

844440

Description

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.

Trial arms

Trial start

2021-02-07

Estimated PCD

2022-08-28

Trial end

2022-08-28

Status

Completed

Phase

Early phase I

Treatment

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.

Arms:

Naproxen sodium

Other names:

Aleve

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.

Arms:

Acetaminophen

Other names:

Extra Strength Tylenol

Tramadol

50 mg by mouth every 6 hours as needed for pain

Arms:

Acetaminophen, Naproxen sodium

Other names:

Ultram

Size

Primary endpoint

Pain Intensity Scores on Numeric Pain Intensity Scale 0-6 Hours

Up to 6 hours

Pain Intensity Scores From 6 Through 72 Hours (Multi-dose Phase)

6-72 hours Post initial Dose

Peak Plasma IL-6 Concentrations

6 hours

Plasma IL-6 Change From Baseline

6 hours post dose

Eligibility criteria

Inclusion Criteria: * Subject requires surgical placement of one or two (adjacent) dental implants * Ability to read and sign informed consent * Males and females for 18-75 years of age * Non-smokers * Negative urine drug screen Exclusion Criteria * Advanced periodontal disease (\>20% Clinical Attachment Loss \>20% radiographic bone loss) * History of bisphosphonate usage * Medical history or medical condition that makes any of the study medications (naproxen sodium, acetaminophen, tramadol, etc.) inappropriate treatment options including any scheduled or recent cardiac procedures (within 6 months), a history of GI ulcers, liver or kidney disease, and anticoagulant or lithium intake. * History of an allergic reaction to any pain reliever/fever reducer * Contraindication to opioid use * Positive urine drug screen for drugs of abuse unless on stable doses of a non-analgesic drug for a legitimate medical purpose * Pregnancy - A urine pregnancy test will be performed immediately before the scheduled surgery on all women of child-bearing potential * Local or systemic diseases that affects wound healing and inflammatory biomarkers (diabetes, autoimmune (rheumatoid arthritis), or inflammatory disorders - osteoarthritis is allowed). * Smokers on this pilot study because it can affect levels of inflammatory biomarkers - a urine cotinine test will be performed immediately prior to the scheduled surgery on all subjects even if participant denies smoking history * History of systemic steroid use over 2 weeks within last 2 years. * Poor oral hygiene on a non-compliant individual.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Double blind, randomized, active-controlled, two arms', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': 'Administration of naproxen or acetaminophen will be masked by over-encapsulation', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 30, 'type': 'ACTUAL'}}

Updated at

2024-05-16

1 organization

3 products

3 indications

Organization

Hersh, Elliot V., DMD, MS, PhD

Product

Indication

Indication

Indication

Product

Product