NCT07423663

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
63

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Sep 2024

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2024

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 5, 2025

Completed
9 months until next milestone

First Posted

Study publicly available on registry

February 20, 2026

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2026

Completed
22 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

February 20, 2026

Status Verified

February 1, 2026

Enrollment Period

1.5 years

First QC Date

June 5, 2025

Last Update Submit

February 13, 2026

Conditions

Asymptomatic Apical Periodontitis

Keywords

Asymptomatic Apical Periodontitispectinbio-c tempCalcium Hydroxide

Outcome Measures

Primary Outcomes (1)

  • Microbiome Changes

    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

Study Arms (3)

Calcium Hydroxide Intracanal medication

ACTIVE COMPARATOR

Patients receiving CaOH (Metapaste) intracanal medication

Drug: Calcium Hydroxide Intracanal medication

Calcium silicate based intracanal medication

EXPERIMENTAL

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

Drug: Calcium silicate based intracanal medication

Pectin

EXPERIMENTAL

Patients receiving Pectin intracanal medication

Drug: Pectin

Interventions

Calcium Hydroxide Intracanal medicationDRUG

Patients receiving CaOH (Metapaste) intracanal medication

Calcium Hydroxide Intracanal medication
Calcium silicate based intracanal medicationDRUG

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

Calcium silicate based intracanal medication
PectinDRUG

Patients receiving Pectin intracanal medication

Pectin

Eligibility Criteria

Age21 Years - 49 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Suez Canal University

Ismailia, Ismailia Governorate, 41511, Egypt

Location

MeSH Terms

Interventions

Pectins

Intervention Hierarchy (Ancestors)

BiopolymersPolymersMacromolecular SubstancesPolysaccharidesCarbohydratesPlant ExtractsPlant PreparationsBiological ProductsComplex Mixtures

Study Officials

  • Omar Montaser, M.D.Sc

    Suez Canal University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer of Endodontics, Faculty of Dentistry, Suez Canal University

Study Record Dates

First Submitted

June 5, 2025

First Posted

February 20, 2026

Study Start

September 1, 2024

Primary Completion

March 10, 2026

Study Completion

April 1, 2026

Last Updated

February 20, 2026

Record last verified: 2026-02

Locations

EG(1)