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Clinical Trials/NCT07603934
NCT07603934RecruitingPhase 1

Evaluation of Postoperative Pain After Using Ibuprofen, Nitrofurantoin, or Calcium Hydroxide as Intracanal Medicaments in Root Canal Treatment of Necrotic Mandibular Posterior Teeth. A Randomized Controlled Trial

Cairo University1 site in 1 country111 target enrollmentStarted: December 15, 2025Last updated:
Interventions

Trial Snapshot

Phase
Phase 1
Status
Recruiting
Enrollment
111
Locations
1

Study Overview

Brief Summary

The aim of this study is to assess the effect of ibuprofen, nitrofurantoin, and calcium hydroxide on postoperative pain after endodontic treatment of necrotic mandibular posterior teeth

Research question/hypothesis:

In patients with necrotic pulps in their mandibular posterior teeth, there would be no difference in the incidence and/or severity of postoperative pain after the use of ibuprofen, nitrofurantoin, or calcium hydroxide intracanal medications.

The study will evaluate postoperative pain after using either of the tested drugs as an intracanal medication amidst visits. of endodontic treatment in cases where pulp necrosis is confirmed.

Detailed Description

  • Trial design:

  • A Randomized controlled, double-blind, parallel-arm, clinical trial.

  • Allocation ratio 1:1:1

  • Framework: superiority

  • Study settings:

Outpatient clinic of Endodontics at the Faculty of Dentistry, Egyptian Russian University, Badr city, Cairo governorate, Egypt.

  • Eligibility criteria

  • Inclusion criteria:

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Masking Description

Masking Description

Eligibility Criteria

Ages
18 Years to 40 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Patients with necrotic pulps.
  • Adult, healthy patients, older than 18 years old
  • Males and females.
  • Patient with the ability to understand and use pain scales.
  • Patient who accepts enroll to the study.

Exclusion Criteria

  • Patients' allergies or any other contraindication to any of the medications used.
  • Pregnant and lactating females.
  • Patients have been taking pain medication 12 hours earlier.
  • Patients who have more than one symptomatic mandibular tooth in the same quadrant.
  • Patients with contributory medical history (ASA>II).

Arms & Interventions

calcium hydroxide

Active Comparator

Intervention: Calcium Hydroxide (Drug)

ibuprofen

Experimental

Ibuprofen. a NSAID, will be ground and formed into a paste to be placed inside the root canals of necrotic mandibular posterior teeth, to explore its effects on post-operative pain

Intervention: ibuprofen (Drug)

nitrofurantoin

Experimental

Intervention: Nitrofurantoin (Drug)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Maha Nasr

Assistant Professor

Cairo University

Study Sites (1)

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