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NCT Number: NCT05361278

Evaluation of 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.

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Key information

Conditions

Dental Caries Bacterial Infections Bacterial Infections and Mycoses Infection, Bacterial Infections Stomatognathic Diseases Tooth Demineralization Tooth Diseases Tooth, Deciduous

Age range

4 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Damascus University

Damascus, 30621, Syria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Chlorhexidine solution

Other
  • 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.

Activated chlorhexidine solution

Other
  • 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.

Chlorhexidine gel

Other
  • 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.

Activated chlorhexidine gel

Other
  • 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.

Sodium Hypochlorite Solution

Other
  • 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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Damascus University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
May 4, 2022
Registry last updated
May 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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