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

NCT06291623 | Completed Phase 1

• 1 other identifier: Molecular Analysis
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bacterial Viability of Necrotic Pulp With Asymptomatic Apical Periodontitis

Keywords

Dna , Rna extraction

Outcome Measures

Primary Outcomes (1)

• minimizing of viable bacteria which showed by Real time PCR

  viable bacteria minimizing of Necrotic single canal with asymptomatic apical periodontitis

  after one week

Study Arms (4)

Pre disinfection (30% H2O2, followed by 2.5% NaOCl) NaOCl inactivated with 5% sodium thiosulfate.

EXPERIMENTAL

sample was taken before pre disinfection protocol (30% H2O2, followed by 2.5% NaOCl) NaOCl will be inactivated with 5% sodium thiosulfate.

Drug: Glycyrrhizin

Post disinfection (30% H2O2, followed by 2.5% NaOCl) NaOCl inactivated with 5% sodium thiosulfate.

EXPERIMENTAL

sample was taken after pre disinfection protocol, to check the sterility of the disinfected tooth surface and access

Drug: Glycyrrhizin

Group 1 (n = 10): Ca(OH)2

EXPERIMENTAL

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

Group 2 (n = 10): Glycyrrhizin

EXPERIMENTAL

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

Interventions

Glycyrrhizin DRUG

used as intracanal medication for one week

Also known as: Calcium hydroxide

Group 1 (n = 10): Ca(OH)2; Group 2 (n = 10): Glycyrrhizin; Post disinfection (30% H2O2, followed by 2.5% NaOCl) NaOCl inactivated with 5% sodium thiosulfate.; Pre disinfection (30% H2O2, followed by 2.5% NaOCl) NaOCl inactivated with 5% sodium thiosulfate.

Eligibility Criteria

• Age: 19 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University

Al Mansurah, Dakahliya, 35511, Egypt

Location

MeSH Terms

Interventions

Glycyrrhizic Acid; Calcium Hydroxide

Intervention Hierarchy (Ancestors)

Pentacyclic Triterpenes; Triterpenes; Terpenes; Hydrocarbons; Organic Chemicals; Hydroxides; Alkalies; Inorganic Chemicals; Calcium Compounds; Anions; Ions; Electrolytes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2024
• First Posted: March 4, 2024
• Study Start: May 3, 2022
• Primary Completion: December 20, 2023
• Study Completion: January 15, 2024
• Last Updated: August 28, 2025

Record last verified: 2024-01

Locations

EG (1)