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NCT Number: NCT07423663

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Asymptomatic Apical Periodontitis

Age range

21 year–49 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Suez Canal University

Ismailia, Ismailia Governorate, 41511, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Calcium Hydroxide Intracanal medication

Drug

Patients receiving CaOH (Metapaste) intracanal medication

Calcium silicate based intracanal medication

Drug

Patients receiving Calcium silicate based (Bio-C Temp) intracanal medication

Pectin

Drug

Patients receiving Pectin intracanal medication

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Suez Canal University

Other

Collaborators

  • University of Leeds

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 20, 2026
Registry last updated
Feb 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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