Molecular Analysis of Intracanal Microbes After Chemomechanical Procedure and Root Canal Medication: A Randomized Controlled Trial

August 21, 2025 updated by: Mansoura University
This study aimed to evaluate clinically the intracanal microbes at molecular level after using established root canal medicament Calcium hydroxide and potential root canal medicament Glycyrrhizin.and Decontamination Analysis of Controls samples.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Bacteria and their by-products are the main etiologic factors for pulpal and periapical diseases. The goals of endodontic treatment are to achieve complete disinfection and prevent reinfection in the root canal system and periapical tissues. Sterilization of root canals is limited by the presently available techniques, instruments, irrigants and intracanal medication. Thus, the focus should be on reducing intracanal bacterial populations to levels that are compatible with periapical tissue healing.Because root canal medicaments can come in contact with periapical tissue, in addition to having good antibacterial ability, they must also be biocompatible. In selecting root canal medicaments, it is necessary to consider their therapeutic benefits against their potential cytotoxic effects. Ideal root canal medicaments should have strong antibacterial properties and minimal cytotoxic effect on the host tissues.Globally, plants and their products are used for improving health. Plant extracts contain bioactive compounds like polyphenols, flavonoids, and many other compounds and chemical substances which play important roles to treat diseases. Due to health benefits, phytochemicals from plants generate a lot of interest, demanding further scientific evaluation.Glycyrrhiza which is known as licorice belonging to the Fabaceae, is native to southern Europe and parts of Asia . Glycyrrhizin has been labelled Generally Recognized as Safe (GRAS) by United States Food and Drug Administration (FDA) and has been considered safe for human consumption.Licorice roots have been used as a remedy for cough, laxative, menopausal hot flashes, peptic ulcer, and viral diseases . Licorice contains more than 20 triterpenoids and nearly 300 flavonoids. Among them, glycyrrhizin, 18 β-glycyrrhetinic acid, liquiritigenin, licochalcone A, licochalcone E and glabridin are the main active components which possess antimicrobial, antioxidant and anti-inflammatory activities.Evaluation of intra canal Bacterial levels and species before and after Chemomechanical procedures have been extensively explored by both culture (phenotype) and molecular techniques (genotype) . The latter became choice methods to assess persistent endodontic bacteria because of their high sensitivity and the ability to detect as-yet-uncultivated/difficult-to-culture bacteria.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
    • Dakahliya
      • Al Mansurah, Dakahliya, Egypt, 35511
        • Mansoura 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

Single-rooted teeth with a single canal, necrotic pulp (did not respond to sensitivity testing) and symptomatic apical periodontitis

  • The age ranges from 19 to 60 years

Exclusion Criteria:- Receiving antibiotic treatment within the preceding 3 months.

  • Reporting systemic disease.
  • Teeth that could not be isolated with rubber dam.
  • Teeth with periodontal pockets deeper than 3 mm.
  • Root fracture or badly decayed teeth.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Pre disinfection (30% H2O2, followed by 2.5% NaOCl) NaOCl inactivated with 5% sodium thiosulfate.
sample was taken before pre disinfection protocol (30% H2O2, followed by 2.5% NaOCl) NaOCl will be inactivated with 5% sodium thiosulfate.
Drug: Glycyrrhizin
used as intracanal medication for one week
Other Names:
  • Calcium hydroxide
Experimental: Post disinfection (30% H2O2, followed by 2.5% NaOCl) NaOCl inactivated with 5% sodium thiosulfate.
sample was taken after pre disinfection protocol, to check the sterility of the disinfected tooth surface and access
Drug: Glycyrrhizin
used as intracanal medication for one week
Other Names:
  • Calcium hydroxide
Experimental: Group 1 (n = 10): Ca(OH)2
3 samples was taken before and after the treatment. Sample 1 was taken before Chemomechanical procedures Sample 2 was taken immediately after Chemomechanical procedures, intracanal medication was placed for 1 week Sample 3 was taken immediately after intracanal medication was removed
Drug: Glycyrrhizin
used as intracanal medication for one week
Other Names:
  • Calcium hydroxide
Experimental: Group 2 (n = 10): Glycyrrhizin
3 samples was taken before and after the treatment. Sample 1 was taken before Chemomechanical procedures Sample 2 was taken immediately after Chemomechanical procedures, intracanal medication was placed for 1 week Sample 3 was taken immediately after intracanal medication was removed
Drug: Glycyrrhizin
used as intracanal medication for one week
Other Names:
  • Calcium hydroxide

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
minimizing of viable bacteria which showed by Real time PCR
Time Frame: after one week
viable bacteria minimizing of Necrotic single canal with asymptomatic apical periodontitis
after one week

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mansoura 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 3, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 20, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 15, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 14, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 26, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 4, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 28, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 21, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Molecular Analysis

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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