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

Not Applicable

Completed

• Conditions: Dental Caries; Tooth, Deciduous; Infection, Bacterial
• Interventions: Other: Chlorhexidine gel; Other: Chlorhexidine solution; Other: Activated chlorhexidine gel; Other: Activated chlorhexidine solution; Other: Sodium hypochlorite solution

• Registration Number: NCT05361278
• Lead Sponsor: Damascus University

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.

Study Timeline

• Study Start: 2021-01-15
• Primary Completion: 2021-12-21
• Study Completion: 2022-02-19
• Status Verified: 2022-04
• Study First Submitted: 2022-04-29
• Study First Submitted QC: 2022-04-29
• Last Update Submitted: 2022-04-29
• Study First Posted: 2022-05-04
• Last Update Posted: 2022-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Chlorhexidine irrigation gel	Chlorhexidine gel	CHx 2% gel will be used.
Chlorhexidine irrigation solution	Chlorhexidine solution	CHx 2% solution will be used.
Activated chlorhexidine irrigation gel	Activated chlorhexidine gel	CHx 2% gel will be used with ultrasonic activation.
Activated chlorhexidine irrigation solution	Activated chlorhexidine solution	CHx 2% solution will be used with ultrasonic activation.
Sodium hypochlorite irrigation solution	Sodium hypochlorite solution	NaOCl 5,25% solution will be used.

Primary Outcome Measures

Name	Time	Method
Logarithmic reduction of bacterial count within the root canal of activated chlorhexidine solution.	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.
Logarithmic reduction of bacterial count within the root canal of sodium hypochlorite solution.	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.
Logarithmic reduction of bacterial count within the root canal of chlorhexidine gel.	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.
Logarithmic reduction of bacterial count within the root canal of chlorhexidine solution.	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.
Logarithmic reduction of bacterial count within the root canal of activated chlorhexidine gel.	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.

Trial Locations

Locations (1)

Damascus University; 🇸🇾 Damascus, Syrian Arab Republic