Phase 4
N=30
OTC Naproxen and Acetaminophen Anti-Inflammatory Action in Dental Implant Patients
Osseointegrated Dental Implantation · Pain, Acute
Bottom Line
View on ClinicalTrials.gov: NCT04694300 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
May 2024
Primary outcome: Primary: Pain Intensity Scores on Numeric Pain Intensity Scale 0-6 Hours — 1; 3 score on a scale — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Naproxen (Drug); Acetaminophen (Drug); Tramadol (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hersh, Elliot V., DMD, MS, PhD
- Primary completion
- Aug 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Intensity Scores on Numeric Pain Intensity Scale 0-6 Hours |
1; 3 | <0.05 sig |
| PRIMARY Pain Intensity Scores From 6 Through 72 Hours (Multi-dose Phase) |
0.3; 1.7 | <0.05 sig |
| PRIMARY Peak Plasma IL-6 Concentrations |
6.5; 12.1 | 0.12 |
| PRIMARY Plasma IL-6 Change From Baseline |
276.9; 519.1 | <0.05 sig |
| SECONDARY Rescue Analgesic Use |
0; 3 | — |
| SECONDARY Rescue Medication Use Outpatient Phase (6-72 Hours) |
2; 5 | — |
| SECONDARY Peak GCF IL-1β Levels |
263; 456 | 0.29 |
| SECONDARY COX-1 Activity Percent of Baseline (Pre-surgery) |
3.7; 77.4 | <0.05 sig |
| SECONDARY COX-2 Activity |
48.4; 52.4 | 0.59 |
| SECONDARY Peak GCF IL-8levels |
2962; 5729 | 0.14 |
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.
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.
Data sourced from ClinicalTrials.gov (NCT04694300). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.