Evaluation of Gel and Solution of Chlorhexidine in Disinfection Root Canals of Primary Anterior Teeth.

April 29, 2022 updated by: Damascus University

Evaluation of Irrigation Effectiveness for Gel and Solution of Chlorhexidine in Disinfection Root Canals of Primary Anterior Teeth.

The process of removing bacteria and their products from the root canals is an essential step that is achieved through the combination of mechanical preparation and irrigation with chemicals. However, mechanical preparation alone can not reduce the microbial formations inside root canals, so at least about 35% of the root canal walls remain without the preparation tools reaching them.

Many irrigants were used to irrigate the root canals, as sodium hypochlorite and chlorhexidine are the most famous. Although most studies have proven the effectiveness of sodium hypochlorite with its different concentrations in accomplishing this task, some of them showed the inability of the irrigant fluid to eliminate Enterococcus faecalis inside the canals. These bacteria are highly resistant, and therefore endodontic treatment fails in the long term.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Bacteria and their products play an essential role in the initiation and persistence of endodontic diseases. Therefore, eliminating them and preventing the return of their effectiveness is the desired goal in any successful endodontic treatment in the short and long term.

Due to the fact that mechanical preparation of the root canal alone is not capable of removing the entire bacterial content, chemical irrigants were considered necessary to reduce the number of bacteria and toxins resulting from them. Until now, there is no irrigant capable of removing the entire bacterial content from the root canal.

Despite the many advantages of sodium hypochlorite, several studies have revealed the toxicity of the solution in high concentrations of it, and it tends to cause tissue irritation when it comes into contact with the apical tissues.

Chlorhexidine has been used for a long time in dentistry due to its antibacterial properties, long period of effect, and relatively low toxicity. This has prompted its use as an irrigant and an intra-canal dressing in endodontic treatment.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

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

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

4 years to 9 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Definitely positive or positive ratings of Frank scale.
  2. Physiological root resorption no more than the apical third
  3. Symptoms or signs of pulpal necrosis with or without radial lesions (swelling - fistua - abnormal movement).
  4. At least 2 mm of bone surrounding the permanent bud.
  5. Children who have not taken antibiotics in the past 3 months.

Exclusion Criteria:

  1. Systematic or mental disorders.
  2. Definitely negative or negative ratings of Frankel scale
  3. Existence external or internal abnormal absorption.

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: SINGLE_GROUP
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Chlorhexidine irrigation solution
CHx 2% solution will be used.
Other: Chlorhexidine solution
  • Irrigate the root canal with 1 ml of 2% CHx solution between each file 1 mm from the apical foramen by using a 27-gauge irrigation needle.
  • Irrigate the root canal with 3 ml of the solution after using the last file.
  • Irrigation with 3 ml of 0.5% Tween 80 and 0.07 % lecithin to remove residual chlorhexidine solution.
  • Drying the canal with paper points (placing a 20 size paper point for 60 seconds in each canal) to take the bacterial smear.
  • Follow-up of endodontic treatment procedures for the treated tooth.
EXPERIMENTAL: Activated chlorhexidine irrigation solution
CHx 2% solution will be used with ultrasonic activation.
Other: Activated chlorhexidine solution
  • Irrigate the root canal with 1 ml of 2% CHx solution between each file 1 mm from the apical foramen by using a 27-gauge irrigation needle with activation using an ultrasonic irrigation head.
  • Irrigate the root canal with 3 ml of the solution after using the last file with activation using an ultrasonic irrigation head.
  • Irrigation with 3 ml of 0.5% Tween 80 and 0.07 % lecithin to remove residual chlorhexidine solution.
  • Drying the canal with paper points (placing a 20 size paper point for 60 seconds in each canal) to take the bacterial smear.
  • Follow-up of endodontic treatment procedures for the treated tooth.
EXPERIMENTAL: Chlorhexidine irrigation gel
CHx 2% gel will be used.
Other: Chlorhexidine gel
  • Irrigate the root canal with 1 ml of 2% CHx gel between each file 1 mm from the apical foramen by using a 27-gauge irrigation needle.
  • Irrigate the root canal with 3 ml of the gel after using the last file.
  • Irrigation with 3 ml of 0.5% Tween 80 and 0.07 % lecithin to remove residual chlorhexidine gel.
  • Drying the canal with paper points (placing a 20 size paper point for 60 seconds in each canal) to take the bacterial smear.
  • Follow-up of endodontic treatment procedures for the treated tooth.
EXPERIMENTAL: Activated chlorhexidine irrigation gel
CHx 2% gel will be used with ultrasonic activation.
Other: Activated chlorhexidine gel
  • Irrigate the root canal with 1 ml of 2% CHx gel between each file 1 mm from the apical foramen by using a 27-gauge irrigation needle with activation using an ultrasonic irrigation head.
  • Irrigate the root canal with 3 ml of the gel after using the last file with activation using an ultrasonic irrigation head.
  • Irrigation with 3 ml of 0.5% Tween 80 and 0.07 % lecithin to remove residual chlorhexidine gel.
  • Drying the canal with paper points (placing a 20 size paper point for 60 seconds in each canal) to take the bacterial smear.
  • Follow-up of endodontic treatment procedures for the treated tooth.
OTHER: Sodium hypochlorite irrigation solution
NaOCl 5,25% solution will be used.
Other: Sodium hypochlorite solution
  • Irrigate the root canal with 1 ml of 5.25% sodium hypochlorite solution between each file 1 mm from the apical foramen by using a 27-gauge irrigation needle.
  • Irrigate the root canal with 3 ml of the solution after using the last file.
  • Irrigating the canal with 3 ml of 5% sodium thiosulfate solution to remove residual of sodium hypochlorite.
  • Drying the canal with paper points (placing a 20 size paper point for 60 seconds in each canal) to take the bacterial smear.
  • Follow-up of endodontic treatment procedures for the treated tooth.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Logarithmic reduction of bacterial count within the root canal of chlorhexidine solution.
Time Frame: 24 hours after sample incubation
Set the Petri dish on a grid background and count the colonies in each grid cell, moving in a methodical pattern through all of the cells.
24 hours after sample incubation
Logarithmic reduction of bacterial count within the root canal of activated chlorhexidine solution.
Time Frame: 24 hours after sample incubation
Set the Petri dish on a grid background and count the colonies in each grid cell, moving in a methodical pattern through all of the cells.
24 hours after sample incubation
Logarithmic reduction of bacterial count within the root canal of chlorhexidine gel.
Time Frame: 24 hours after sample incubation
Set the Petri dish on a grid background and count the colonies in each grid cell, moving in a methodical pattern through all of the cells.
24 hours after sample incubation
Logarithmic reduction of bacterial count within the root canal of activated chlorhexidine gel.
Time Frame: 24 hours after sample incubation
Set the Petri dish on a grid background and count the colonies in each grid cell, moving in a methodical pattern through all of the cells.
24 hours after sample incubation
Logarithmic reduction of bacterial count within the root canal of sodium hypochlorite solution.
Time Frame: 24 hours after sample incubation
Set the Petri dish on a grid background and count the colonies in each grid cell, moving in a methodical pattern through all of the cells.
24 hours after sample incubation

Collaborators and Investigators

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

Sponsor

Damascus University

Investigators

  • Principal Investigator: Rahaf ِA kharsa, DDs, MSc student in Pedodontics, University of Damascus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

January 15, 2021

Primary Completion (ACTUAL)

December 21, 2021

Study Completion (ACTUAL)

February 19, 2022

Study Registration Dates

First Submitted

April 29, 2022

First Submitted That Met QC Criteria

April 29, 2022

First Posted (ACTUAL)

May 4, 2022

Study Record Updates

Last Update Posted (ACTUAL)

May 4, 2022

Last Update Submitted That Met QC Criteria

April 29, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UDDS-Pedo-02-2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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