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Search / Trial NCT04608981

Effect of Diclofenac Potassium Versus Prednisolone on Post-endodontic Pain and Pulpal IL-8 Expression

Launched by CAIRO UNIVERSITY · Oct 25, 2020

Trial Information

Current as of August 02, 2025

Unknown status

Keywords

Prednisolone Diclofenac Potassium Interleukin 8

ClinConnect Summary

After confirming the diagnosis and making sure that the patient conforms to all eligibility criteria, the principal investigator will enroll the patient in the study.

* Patients will be asked to rate their pre-operative pain intensity (ie, before the commencement of any treatment \[baseline score\]; on the visual analogue scale "VAS"
* Enrolled patients will be randomly assigned into one of three groups:

Intervention Group 1 (Diclofenac Potassium): single, oral dose of 50 mg diclofenac potassium pre-medication (Cataflam; NOVARTIS Pharma, Basel, Switzerland) one hour before starting endodo...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Age between 18-50 years.
  • Males and females.
  • American Society of Anesthesiologists class 1 or 2.
  • * Mandibular premolar teeth with:
  • Endodontic pulpal diagnosis of symptomatic irreversible pulpitis
  • Normal/slight widening in the periodontal membrane space (PMS).
  • Patients who had not taken any anti-inflammatory drugs the day of the root canal procedure unless they belong to one of the intervention groups.
  • Patients who accept to participate in the trial, understand the VAS, and can sign the informed consent
  • Exclusion Criteria:
  • Cases with acute peri-apical conditions (acute apical periodontitis/ acute apical abscess), pulpal necrosis, previously initiated therapy, or previously treated.
  • Teeth other than single-rooted teeth.
  • Radiographic evidence of external or internal root resorption vertical root fracture, perforation, or calcification.
  • Immature teeth.
  • Unrestorable teeth or teeth with severe periodontal disease.
  • Patients with a known allergy, sensitivity, or history of other adverse reactions to the medications administered.
  • Patients with a history of active peptic ulcer within the preceding 12 months, bleeding problems, anticoagulant use within the last month, or kidney disease.
  • Patients who took analgesics/ anti-inflammatory drugs (steroidal or non-steroidal) the day of endodontic treatment.
  • Pregnant or nursing females.
  • Patients who are unable to provide informed consent

About Cairo University

Cairo University, a premier institution in Egypt, is dedicated to advancing medical research and education through innovative clinical trials. With a strong emphasis on improving healthcare outcomes, the university collaborates with various stakeholders to conduct rigorous scientific studies that address critical health challenges. Leveraging its extensive resources and expert faculty, Cairo University aims to contribute valuable insights to the medical community and enhance patient care both locally and globally. Through its commitment to ethical research practices and excellence, the university plays a pivotal role in shaping the future of healthcare in the region.

Locations

Patients applied

0 patients applied

Trial Officials

Ahmed A Soliman, MSc

Principal Investigator

Cairo University

Khaled Ezzat, PhD

Study Director

Cairo University

Sara S Abouelenien, PhD

Study Chair

Cairo University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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