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Evaluation of Methylprednisolone or Ibuprofen on Efficacy of Nerve Blocks With Symptomatic Irreversible Pulpitis
Phase 3
Waitlist Available
Research Sponsored by Walter Reed National Military Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 hours
Awards & highlights
Approved for 50 Other Conditions
All Individual Drugs Already Approved
No Placebo-Only Group
Pivotal Trial
Summary
This trial tests if taking ibuprofen or methylprednisolone before a dental anesthetic injection improves its effectiveness in adults with severe tooth pain. Both medications aim to reduce inflammation and pain, which might help the anesthetic work better. Methylprednisolone is a corticosteroid used for its strong anti-inflammatory actions, which can help reduce pain.
Eligible Conditions
- Toothache
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 48 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 hours
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Analgesic Effect on Nerve Block
Secondary study objectives
Analgesic Effect on Post-Operative Pain
Analgesic Effect on Supplemental Anesthesia Techniques
Awards & Highlights
Approved for 50 Other Conditions
This treatment demonstrated efficacy for 50 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Group I: 800mg IbuprofenExperimental Treatment1 Intervention
Subject will take 800mg of Ibuprofen 45 minutes prior to anesthetic delivery.
Group II: 40mg MethylprednisoloneExperimental Treatment1 Intervention
Subject will take 40mg of Methylprednisolone 45 minutes prior to anesthetic delivery.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Methylprednisolone
FDA approved
Ibuprofen
FDA approved
Find a Location
Who is running the clinical trial?
Walter Reed National Military Medical CenterLead Sponsor
143 Previous Clinical Trials
33,324 Total Patients Enrolled