The Effect of Different Intra-canal Medications on Postoperative Pain

NCT07603934 | Recruiting Early Phase 1 DMC

• 1 other identifier: ERU2
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulp Necrosis, Apical Periodontitis

Keywords

Necrotic Pulp

Outcome Measures

Primary Outcomes (1)

• Intensity of Postoperative pain

  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 Outcomes (2)

• Incidence of Postoperative pain

  Up to 72 hours after placement of intracanal medicament

• Postoperative Analgesic Consumption

  Up to 72 hours postoperatively

Study Arms (3)

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

Drug: ibuprofen

nitrofurantoin

EXPERIMENTAL

Drug: Nitrofurantoin

calcium hydroxide

ACTIVE COMPARATOR

Drug: Calcium Hydroxide

Interventions

ibuprofen DRUG

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

ibuprofen

Nitrofurantoin DRUG

Nitrofurantoin tablets will be formed into a paste to be placed inside the root canals of necrotic mandibular premolars during endodontic treatment.

nitrofurantoin

Calcium Hydroxide DRUG

Calcium Hydroxide intracanal medicament will be placed inside the root canals of mandibular necrotic posterior teeth during endodontic treatment.

calcium hydroxide

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Cairo University: lead
• Egyptian Russian University: collaborator
• Fayoum University: collaborator

Study Sites (1)

Faculty of Oral and Dental Medicine, Egyptian Russian University

Cairo, Cairo Governorate, 4450113, Egypt

RECRUITING

MeSH Terms

Conditions

Dental Pulp Necrosis; Periapical Periodontitis

Interventions

Ibuprofen; Nitrofurantoin; Calcium Hydroxide

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Periapical Diseases; Jaw Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Nitrofurans; Nitro Compounds; Furans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Hydroxides; Alkalies; Inorganic Chemicals; Calcium Compounds; Anions; Ions; Electrolytes

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Masking Description
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: May 22, 2026
• Study Start: December 15, 2025
• Primary Completion (Estimated): August 15, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: May 22, 2026

Record last verified: 2025-05

Locations

EG (1)