Antibacterial Effect of Two Different Intracanal Medicaments and Their Effect on Post-operative Pain

NCT07388888 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: FDASU-Rec IM012482
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluation of antibacterial effect of two different intracanal medicaments on bacterial load in infected mature permanent teeth and their effect on post-operative pain level.

Conditions

Pulp Necrosis

Keywords

effect of two intracanal medicaments on bacterial load and post operative pain level in mature teeth with necrotic pulp

Outcome Measures

Primary Outcomes (1)

• Bacterial load.

  Samples will be collected from the infected root canal before and after injection of intracanal medicaments then bacterial colonies will be counted for colony forming units per milliliter (CFU/ml) to assess the effect of the intracanal medicaments used.

  two weeks

Secondary Outcomes (1)

• Visual Analogue Scale (VAS) to measure post operative pain level.

  12 hours, 24 hours, 48 hours, 72 hours.

Study Arms (3)

calcium hydroxide (Ca(OH)2)

ACTIVE COMPARATOR

intracanal medicament in infected root canal

Drug: Calcium Hydroxide (Ca(OH)2)

Chitosan nano particles (CNPs)

EXPERIMENTAL

intracanal medication in infected root canal

Drug: chitosan nanoparticles gel

control

NO INTERVENTION

Interventions

Calcium Hydroxide (Ca(OH)2) DRUG

Non setting calcium hydroxide intracanal medicament is injected through the root canal for two weeks

calcium hydroxide (Ca(OH)2)

chitosan nanoparticles gel DRUG

Nano chitosan gel is injected through the root canal as an intracanal medicament for two weeks

Chitosan nano particles (CNPs)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• free medical history,
• mature infected permanent single rooted teeth diagnosed clinically and radiographically with adequate coronal structure for proper isolation, temporization and restoration.

You may not qualify if:

• Patients who are not included in the age range of the study or having a systemic condition.
• Teeth with severe fractures or resorption or periodontally compromised.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Faculty of Dentistry Ain Shams University

Cairo, Egypt

Location

MeSH Terms

Conditions

Dental Pulp Necrosis

Interventions

Calcium Hydroxide

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Calcium Compounds; Anions; Ions; Electrolytes

Central Study Contacts

Rana M Nagdy, MSc

CONTACT

+201006224327; Rananagdy@dent.asu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dentist

Study Record Dates

• First Submitted: January 21, 2026
• First Posted: February 5, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: February 5, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)