Phase 4 Completed N=102 Randomized Triple-blind Treatment

Ibuprofen Versus Ibuprofen/Acetaminophen Postoperatively in Patients Needing Root Canal Therapy

Pain, Postoperative

Source: ClinicalTrials.gov NCT03631433 ↗

Enrolled (actual)

102

Serious AEs

—

Results posted

May 2021

Primary outcomePrimary: Heft Parker Visual Analog Scale Pain Scale Pain Measurements — 63; 60 units on a scale

◆ Published Evidence

No publication linked

No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.

Summary

Aim: The purpose of this study was to compare ibuprofen versus an ibuprofen/acetaminophen combination for postoperative pain control in patients requiring root canal treatment with a tooth that is painful to cold and biting. Methodology: Following regular root canal treatment, patients randomly received identical appearing tablets of 600 mg ibuprofen or 600 mg ibuprofen/650 mg acetaminophen to be taken every 6 hours as needed for pain. A 4-day diary was used to record pain and medication use.

Outcome Measures

Outcome	Result	p-value
PRIMARY Heft Parker Visual Analog Scale Pain Scale Pain Measurements	63; 60	—
PRIMARY Number of Participants	20; 18	—

Eligibility Criteria

Inclusion Criteria

mandibular (bottom) or maxillary (top) posterior (back) tooth requiring root canal treatment
mandibular (bottom) or maxillary (top) posterior (back) tooth with symptomatic irreversible pulpitis and symptomatic apical periodontitis (painful tooth to cold and biting)
between the ages of 18 and 65 years of age 3. American Society of Anesthesiologist classification I

Exclusion Criteria

patients younger than 18 or older than 65 years of age
American Society of Anesthesiologist classification II or higher
allergies or contraindications to ibuprofen
allergies or contraindications to acetaminophen
pregnancy
inability to give informed consent

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03631433). 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. Informational only — not medical advice.