CClinicalTrials.gg
CompletedNCT05361278Updated May 4, 2022

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

An interventional study of Chlorhexidine solution and Activated chlorhexidine solution in Dental Caries, Infection, Bacterial and Tooth, Deciduous, sponsored by Damascus University. Completed at 1 site in Syrian Arab Republic. Open to participants aged 4 Years to 9 Years. Per ClinicalTrials.gov, last updated 2022-05-04.

Sponsored by Damascus University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 3 months after the study started (first participant enrolled Jan 2021, registered Apr 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Randomized
Ages
4 Years to 9 Years
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Dental Caries
  • Infection, Bacterial
  • Tooth, Deciduous

Keywords

  • Anterior Primary Tetth
  • Infected canals
  • chlorhexidine
  • Sodium hypochlorite
03

In context

Bacterial Infections

658 studies on the registry are indexed under Bacterial Infections; 100 are open to participants now.

This study's enrollment of 15 is below the median of 84 across 405 interventional studies indexed under Bacterial Infections.

Browse Bacterial Infections studies →

Lead sponsor

Damascus University is the lead sponsor of 206 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
4 Years to 9 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  1. Systematic or mental disorders.
  2. Definitely negative or negative ratings of Frankel scale
  3. Existence external or internal abnormal absorption.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
15 participants (actual)

Study arms

  • Experimental
    Chlorhexidine irrigation solution

    CHx 2% solution will be used.

    Other: Chlorhexidine solution

  • Experimental
    Activated chlorhexidine irrigation solution

    CHx 2% solution will be used with ultrasonic activation.

    Other: Activated chlorhexidine solution

  • Experimental
    Chlorhexidine irrigation gel

    CHx 2% gel will be used.

    Other: Chlorhexidine gel

  • Experimental
    Activated chlorhexidine irrigation gel

    CHx 2% gel will be used with ultrasonic activation.

    Other: Activated chlorhexidine gel

  • Other
    Sodium hypochlorite irrigation solution

    NaOCl 5,25% solution will be used.

    Other: Sodium hypochlorite solution

Interventions

  • OtherChlorhexidine 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.

  • OtherActivated 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.

  • OtherChlorhexidine 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.

  • OtherActivated 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.

  • OtherSodium 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.

06

What researchers measure

Primary outcomes

  1. Logarithmic reduction of bacterial count within the root canal of chlorhexidine solution.

    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.

    Time frame: 24 hours after sample incubation

  2. Logarithmic reduction of bacterial count within the root canal of activated chlorhexidine solution.

    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.

    Time frame: 24 hours after sample incubation

  3. Logarithmic reduction of bacterial count within the root canal of chlorhexidine gel.

    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.

    Time frame: 24 hours after sample incubation

  4. Logarithmic reduction of bacterial count within the root canal of activated chlorhexidine gel.

    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.

    Time frame: 24 hours after sample incubation

  5. Logarithmic reduction of bacterial count within the root canal of sodium hypochlorite solution.

    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.

    Time frame: 24 hours after sample incubation

07

Study locations

1 site
  • Damascus University
    Damascus, 30621, Syrian Arab Republic
08

References and documents

Publications

  • Goud S, Aravelli S, Dronamraju S, Cherukuri G, Morishetty P. Comparative Evaluation of the Antibacterial Efficacy of Aloe Vera, 3% Sodium Hypochlorite, and 2% Chlorhexidine Gluconate Against Enterococcus faecalis: An In Vitro Study. Cureus. 2018 Oct 22;10(10):e3480. doi: 10.7759/cureus.3480. PubMed 30648031 ↗
  • Gomes BP, Ferraz CC, Vianna ME, Berber VB, Teixeira FB, Souza-Filho FJ. In vitro antimicrobial activity of several concentrations of sodium hypochlorite and chlorhexidine gluconate in the elimination of Enterococcus faecalis. Int Endod J. 2001 Sep;34(6):424-8. doi: 10.1046/j.1365-2591.2001.00410.x. PubMed 11556507 ↗
  • Ruksakiet K, Hanak L, Farkas N, Hegyi P, Sadaeng W, Czumbel LM, Sang-Ngoen T, Garami A, Miko A, Varga G, Lohinai Z. Antimicrobial Efficacy of Chlorhexidine and Sodium Hypochlorite in Root Canal Disinfection: A Systematic Review and Meta-analysis of Randomized Controlled Trials. J Endod. 2020 Aug;46(8):1032-1041.e7. doi: 10.1016/j.joen.2020.05.002. Epub 2020 May 12. PubMed 32413440 ↗
  • Walia V, Goswami M, Mishra S, Walia N, Sahay D. Comparative Evaluation of the Efficacy of Chlorhexidine, Sodium Hypochlorite, the Diode Laser and Saline in Reducing the Microbial Count in Primary Teeth Root Canals - An In Vivo Study. J Lasers Med Sci. 2019 Fall;10(4):268-274. doi: 10.15171/jlms.2019.44. Epub 2019 Oct 1. PubMed 31875118 ↗
  • Tirali RE, Bodur H, Ece G. In vitro antimicrobial activity of sodium hypochlorite, chlorhexidine gluconate and octenidine dihydrochloride in elimination of microorganisms within dentinal tubules of primary and permanent teeth. Med Oral Patol Oral Cir Bucal. 2012 May 1;17(3):e517-22. doi: 10.4317/medoral.17566. PubMed 22143724 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 4, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05361278
Lead sponsor
Damascus University
Responsible party
Sponsor
First posted
May 4, 2022
Start date
Jan 15, 2021
Primary completion
Dec 21, 2021
Completion
Feb 19, 2022
Last update
May 4, 2022

Study contacts

Rahaf ِA kharsa, DDs
principal investigator · MSc student in Pedodontics, University of Damascus
Mohannad G Laflouf, Phd
study director · Professor of Pedodontics, Department of Pedodontics, University of Damascus

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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