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

NCT05361278 | Completed

• 1 other identifier: UDDS-Pedo-02-2022
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dental Caries; Infection, Bacterial; Tooth, Deciduous

Keywords

Anterior Primary Tetth; Infected canals; chlorhexidine; Sodium hypochlorite

Outcome Measures

Primary Outcomes (5)

• 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.

  24 hours after sample incubation

• 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.

  24 hours after sample incubation

• 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.

  24 hours after sample incubation

• 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.

  24 hours after sample incubation

• 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.

  24 hours after sample incubation

Study Arms (5)

Chlorhexidine irrigation solution

EXPERIMENTAL

CHx 2% solution will be used.

Other: Chlorhexidine solution

Activated chlorhexidine irrigation solution

EXPERIMENTAL

CHx 2% solution will be used with ultrasonic activation.

Other: Activated chlorhexidine solution

Chlorhexidine irrigation gel

EXPERIMENTAL

CHx 2% gel will be used.

Other: Chlorhexidine gel

Activated chlorhexidine irrigation gel

EXPERIMENTAL

CHx 2% gel will be used with ultrasonic activation.

Other: Activated chlorhexidine gel

Sodium hypochlorite irrigation solution

OTHER

NaOCl 5,25% solution will be used.

Other: Sodium hypochlorite solution

Interventions

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.

Chlorhexidine irrigation solution

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.

Activated chlorhexidine irrigation solution

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.

Chlorhexidine irrigation gel

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.

Activated chlorhexidine irrigation gel

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.

Sodium hypochlorite irrigation solution

Eligibility Criteria

• Age: 4 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

Damascus University

Damascus, 30621, Syria

Location

Related Publications (5)

• 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.

  PMID: 30648031 BACKGROUND

• 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.

  PMID: 11556507 BACKGROUND

• 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.

  PMID: 32413440 BACKGROUND

• 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.

  PMID: 31875118 BACKGROUND

• 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.

  PMID: 22143724 BACKGROUND

MeSH Terms

Conditions

Dental Caries; Bacterial Infections

Interventions

Sodium Hypochlorite

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Hypochlorous Acid; Chlorine Compounds; Inorganic Chemicals; Oxides; Oxygen Compounds; Sodium Compounds

Study Officials

• Rahaf ِA kharsa, DDs

  MSc student in Pedodontics, University of Damascus

  PRINCIPAL INVESTIGATOR

• Mohannad G Laflouf, Phd

  Professor of Pedodontics, Department of Pedodontics, University of Damascus

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2022
• First Posted: May 4, 2022
• Study Start: January 15, 2021
• Primary Completion: December 21, 2021
• Study Completion: February 19, 2022
• Last Updated: May 4, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)