The Effect of Different Intra-canal Medications on Postoperative Pain

May 17, 2026 updated by: Maha Nasr, Cairo University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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:

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

    • Exclusion criteria:

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

The diagnosis of pulp necrosis is confirmed through the patients' history, lack of response to cold testing and negative response to electric pulp tester whenever .The treatment will be done on two- visits.

• Treatment procedure: Each patient will be given an NRS chart to rate her /his presenting pain as preoperative pain. After complete mechanical preparation, each patient will be randomly assigned to either of three groups as follows, group 1: ibuprofen will be used as an intracanal medication, group 2: nitrofurantoin will be used as an intra canal medication and group 3: CaOH will be used as an intracanal medicament. The access cavity will be then sealed with temporary filling (MD-TEMP, META BIOMED CO., LTD. Chungbuuk, Korea). Post-operative instructions and appropriate post-operative rescue medication will be prescribed (400mg Ibuprofen). All patients will be asked to record their postoperative pain level felt on NRS at 6, 12, 24, 48, 72 hours and 7 days.

One week after the first visit, patients will be recalled to the clinic to complete their root canal treatment as recommended. All canals will be dried then obturated by the modified single cone technique using 0.04 taper gutta percha points and epoxy resin sealer. Patients will be referred to an operative or a fixed prosthodontics specialist for crown placement at the Faculty of Dentistry, Egyptian Russian University.

Research objective (state the aim) 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.

Sample size: (if calculation equation is used please state) A total of 111 patients, 37 per group needed for the clinical trial was calculated

Grouping & Randomization used:(specify if present) Three groups Group 1: ibuprofen Group 2: nitrofurantoin Group 3: calcium hydroxide

Outcome variables:

The primary outcome the effect of ibuprofen, nitrofurantoin and calcium hydroxide on postoperative pain after endodontic treatment of necrotic mandibular posterior teeth.

Postoperative pain will be measured using NRS at 6, 12, 24, 48, 72 hours postoperatively. Numerical Rating Scale (NRS) (20): It is an 11-point scale consisting of numbers from 0 through 10; - 0 reading represents "no pain" - 1-3 readings represent "mild pain" - 4- 6 readings represent "moderate pain" - 7- 10 readings represent "severe pain"

Study Type

Interventional

Enrollment (Estimated)

111

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Cairo Governorate
      • Cairo, Cairo Governorate, Egypt, 4450113
        • Recruiting
        • Faculty of Oral and Dental Medicine, Egyptian Russian University
        • Contact:
        • Principal Investigator:
          • Maha Nasr, Assistant Professor
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ibuprofen
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
Drug: ibuprofen
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
Experimental: nitrofurantoin
Drug: Nitrofurantoin
Nitrofurantoin tablets will be formed into a paste to be placed inside the root canals of necrotic mandibular premolars during endodontic treatment.
Active Comparator: calcium hydroxide
Drug: Calcium Hydroxide
Calcium Hydroxide intracanal medicament will be placed inside the root canals of mandibular necrotic posterior teeth during endodontic treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intensity of Postoperative pain
Time Frame: Baseline (preoperative) and at 6, 12, 24, 48 and 72 hours after placement of the intracanal medicament.
Postoperative pain intensity will be self-reported by patients using an 11-point Numerical rating scale (NRS), where 0 represents "no paon" and 10 represents "the worst immaginable pain"
Baseline (preoperative) and at 6, 12, 24, 48 and 72 hours after placement of the intracanal medicament.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Postoperative pain
Time Frame: Up to 72 hours after placement of intracanal medicament
The percentage of patients experiencing any postoperative pain (NRS=0) within the follow-up period
Up to 72 hours after placement of intracanal medicament
Postoperative Analgesic Consumption
Time Frame: Up to 72 hours postoperatively
The total amount of prescribed analgesics consumed by the oatient. this will be measured by counting the total number of Ibuprofen 400 mg tablets taken by patients.
Up to 72 hours postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Collaborators

Fayoum University
Egyptian Russian University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2025

Primary Completion (Estimated)

August 15, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

November 18, 2025

First Submitted That Met QC Criteria

May 17, 2026

First Posted (Actual)

May 22, 2026

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 17, 2026

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ERU2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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