Antimicrobial Effect of Calcium Silicate and Pectin as Intracanal Medications in Necrotic Teeth With Periapical Lesions

February 13, 2026 updated by: omar montassir, Suez Canal University

Antimicrobial Effect of Calcium Silicate and Pectin as Intracanal Medications in Necrotic Teeth With Periapical Lesions :A Randomized Controlled Clinical Trial

It is tackling antimicrobial resistance in endodontics, specifically comparing different intracanal medications used in root canal treatment. Given the growing concern over resistant bacterial strains, our study aims to evaluate the effectiveness of various medicaments in eliminating endodontic pathogens while minimising the risk of resistance development. By integrating microbiological analysis and clinical relevance, our research seeks to provide evidence-based recommendations for optimising intracanal disinfection protocols and improving treatment outcomes in endodontic infections.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

63

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
    • Ismailia Governorate
      • Ismailia, Ismailia Governorate, Egypt, 41511
        • Suez Canal University

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

  • Patients presenting with a single rooted mandibular premolar tooth with a closed apex and a single patent canal type I in Vertucci's classification (Vertucci et al., 1974).
  • Having a necrotic pulp.
  • A pocket depth measurement of < 3 mm.
  • Teeth with no previous history of endodontic treatment.
  • Teeth with periapical lesions of endodontic origin having a periapical index score of 4 or 5 (Orstavik et al., 1986)
  • Patients who took antibiotics within the period of three months before the study.
  • Non-restorable teeth.
  • Teeth with periodontal pockets deeper than 4mm, with or without concomitant or combined endo-perio communication
  • Multirooted teeth.
  • Previously initiated or treated teeth.
  • Teeth with root canal calcifications or resorption.
  • Teeth with internal/external root resorption or root fracture.
  • Immune-compromised patients or patients with systemic diseases i.e. (diabetes mellitus, human immunodeficiency virus, leukemia, neutropenia, undergoing chemo- or systemic corticosteroid therapy)
  • Teeth with root curvature of more than 15 degrees.
  • Pregnant women
  • Patients with known sensitivity to the medicaments used in this study.

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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Calcium Hydroxide Intracanal medication
Patients receiving CaOH (Metapaste) intracanal medication
Drug: Calcium Hydroxide Intracanal medication
Patients receiving CaOH (Metapaste) intracanal medication
Experimental: Calcium silicate based intracanal medication
Patients receiving Calcium silicate based (Bio-C Temp) intracanal medication
Drug: Calcium silicate based intracanal medication
Patients receiving Calcium silicate based (Bio-C Temp) intracanal medication
Experimental: Pectin
Patients receiving Pectin intracanal medication
Drug: Pectin
Patients receiving Pectin intracanal medication

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Microbiome Changes
Time Frame: From enrollment to the end of treatment at 2 weeks
Compare the changes in the microbial composition of the biofilm inside the infected root canal before and after chemo-mechanical preparation and before and after intracanal medicaments application using DNA next-generation sequencing.
From enrollment to the end of treatment at 2 weeks

Collaborators and Investigators

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

Sponsor

Suez Canal University

Collaborators

University of Leeds

Investigators

  • Principal Investigator: Omar Montaser, M.D.Sc, Suez Canal 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)

September 1, 2024

Primary Completion (Estimated)

March 10, 2026

Study Completion (Estimated)

April 1, 2026

Study Registration Dates

First Submitted

June 5, 2025

First Submitted That Met QC Criteria

February 13, 2026

First Posted (Actual)

February 20, 2026

Study Record Updates

Last Update Posted (Actual)

February 20, 2026

Last Update Submitted That Met QC Criteria

February 13, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 645/2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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