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

Primary Purpose

Dental Caries, Infection, Bacterial, Tooth, Deciduous

Status
Completed
Phase
Not Applicable
Locations
Syrian Arab Republic
Study Type
Interventional
Intervention
Chlorhexidine solution
Activated chlorhexidine solution
Chlorhexidine gel
Activated chlorhexidine gel
Sodium hypochlorite solution
Sponsored by
Damascus University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Caries focused on measuring Anterior Primary Tetth, Infected canals, chlorhexidine, Sodium hypochlorite

Eligibility Criteria

4 Years - 9 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Damascus University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Other

Arm Label

Chlorhexidine irrigation solution

Activated chlorhexidine irrigation solution

Chlorhexidine irrigation gel

Activated chlorhexidine irrigation gel

Sodium hypochlorite irrigation solution

Arm Description

CHx 2% solution will be used.

CHx 2% solution will be used with ultrasonic activation.

CHx 2% gel will be used.

CHx 2% gel will be used with ultrasonic activation.

NaOCl 5,25% solution will be used.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
April 29, 2022
Last Updated
April 29, 2022
Sponsor
Damascus University
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1. Study Identification

Unique Protocol Identification Number
NCT05361278
Brief Title
Evaluation of Gel and Solution of Chlorhexidine in Disinfection Root Canals of Primary Anterior Teeth.
Official Title
Evaluation of Irrigation Effectiveness for Gel and Solution of Chlorhexidine in Disinfection Root Canals of Primary Anterior Teeth.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
January 15, 2021 (Actual)
Primary Completion Date
December 21, 2021 (Actual)
Study Completion Date
February 19, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Damascus University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries, Infection, Bacterial, Tooth, Deciduous
Keywords
Anterior Primary Tetth, Infected canals, chlorhexidine, Sodium hypochlorite

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Chlorhexidine irrigation solution
Arm Type
Experimental
Arm Description
CHx 2% solution will be used.
Arm Title
Activated chlorhexidine irrigation solution
Arm Type
Experimental
Arm Description
CHx 2% solution will be used with ultrasonic activation.
Arm Title
Chlorhexidine irrigation gel
Arm Type
Experimental
Arm Description
CHx 2% gel will be used.
Arm Title
Activated chlorhexidine irrigation gel
Arm Type
Experimental
Arm Description
CHx 2% gel will be used with ultrasonic activation.
Arm Title
Sodium hypochlorite irrigation solution
Arm Type
Other
Arm Description
NaOCl 5,25% solution will be used.
Intervention Type
Other
Intervention Name(s)
Chlorhexidine solution
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Activated chlorhexidine solution
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Chlorhexidine gel
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Activated chlorhexidine gel
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Sodium hypochlorite solution
Intervention Description
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 Outcome Measure Information:
Title
Logarithmic reduction of bacterial count within the root canal of chlorhexidine solution.
Description
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
Title
Logarithmic reduction of bacterial count within the root canal of activated chlorhexidine solution.
Description
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
Title
Logarithmic reduction of bacterial count within the root canal of chlorhexidine gel.
Description
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
Title
Logarithmic reduction of bacterial count within the root canal of activated chlorhexidine gel.
Description
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
Title
Logarithmic reduction of bacterial count within the root canal of sodium hypochlorite solution.
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rahaf ِA kharsa, DDs
Organizational Affiliation
MSc student in Pedodontics, University of Damascus
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mohannad G Laflouf, Phd
Organizational Affiliation
Professor of Pedodontics, Department of Pedodontics, University of Damascus
Official's Role
Study Director
Facility Information:
Facility Name
Damascus University
City
Damascus
ZIP/Postal Code
30621
Country
Syrian Arab Republic

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30648031
Citation
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.
Results Reference
background
PubMed Identifier
11556507
Citation
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.
Results Reference
background
PubMed Identifier
32413440
Citation
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.
Results Reference
background
PubMed Identifier
31875118
Citation
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.
Results Reference
background
PubMed Identifier
22143724
Citation
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.
Results Reference
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Evaluation of Gel and Solution of Chlorhexidine in Disinfection Root Canals of Primary Anterior Teeth.

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