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

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

20

Phase

  • 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

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
Intervention / Treatment
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

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

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)

May 3, 2022

Primary Completion (Actual)

December 20, 2023

Study Completion (Actual)

January 15, 2024

Study Registration Dates

First Submitted

February 14, 2024

First Submitted That Met QC Criteria

February 26, 2024

First Posted (Actual)

March 4, 2024

Study Record Updates

Last Update Posted (Estimated)

August 28, 2025

Last Update Submitted That Met QC Criteria

August 21, 2025

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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

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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