Comparison of Antimicrobial Action of Sodium Hypochlorite and Polyhexamethylene Biguanide as Root Canal Irrigants

NCT ID: NCT05306431

Last Updated: 2023-02-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-01

Study Completion Date

2022-11-30

Brief Summary

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The aim of this randomized clinical trial is to compare the antibacterial effects of sodium hypochlorite (NaOCl) and Polyhexamethylene biguanide during root canal treatment .

Detailed Description

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This study will compare the antibacterial effectiveness of sodium hypochlorite and PHMB, to find out whether PHMB can be used as a substitute to NaOCL. Polyhexamethylene biguanide (PHMB), is a disinfectant solution having a broad spectrum of antimicrobial activity and is investigated as an endodontic irrigant. It is non-corrosive, non-toxic and acts by disrupting cell membrane integrity.

Conditions

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Irreversible Pulpitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
The microbiologist will be kept blind to avoid risk of bias.

Study Groups

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Polyhexamethylene biguanide

Polyhexamethylene biguanide (PHMB), is a disinfectant solution having a broad spectrum of antimicrobial activity and is investigated as an endodontic irrigant. It is non-corrosive, non-toxic and acts by disrupting cell membrane integrity. PHMB 0.2% has been recently used as a root canal irrigant in vitro and has shown promising results of antimicrobial effectiveness of \> 99.9% for both PHMB and Sodium hypochlorite

Group Type EXPERIMENTAL

Polyhexamethylene biguanide

Intervention Type DRUG

Polyhexamethylene biguanide (PHMB), is a disinfectant solution having a broad spectrum of antimicrobial activity and is investigated as an endodontic irrigant

Sodium Hypochloride

A number of irrigant solution has thus been proposed to serve the purpose, the most popular being sodium hypochlorite (NaOCl) because of its excellent antimicrobial activity but also the ability to dissolve organic matter.

Group Type EXPERIMENTAL

Sodium Hypochlorite

Intervention Type DRUG

A number of irrigant solution has thus been proposed to serve the purpose, the most popular being sodium hypochlorite (NaOCl) because of its excellent antimicrobial activity but also the ability to dissolve organic matter

Interventions

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Polyhexamethylene biguanide

Polyhexamethylene biguanide (PHMB), is a disinfectant solution having a broad spectrum of antimicrobial activity and is investigated as an endodontic irrigant

Intervention Type DRUG

Sodium Hypochlorite

A number of irrigant solution has thus been proposed to serve the purpose, the most popular being sodium hypochlorite (NaOCl) because of its excellent antimicrobial activity but also the ability to dissolve organic matter

Intervention Type DRUG

Other Intervention Names

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PHMB Bleach

Eligibility Criteria

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Inclusion Criteria

* • Patients aged 18 to 50 years

* Both male and female patients
* Periodontally healthy teeth as determined by Periodontal Probing
* Patients with non-vital necrotic pulps as determined by Cold Test
* Patients with acute apical periodontitis determined by history and clinical examination
* Clinical Findings:

Visual: Carious tooth decay Occlusion: Hyperocclusion Pulp vitality test: Negative Periapical radiograph: Caries involving pulp space and PDL widening Percussion Test: Positive Palpation Test: Negative

• Single rooted teeth as determined radiographically

Exclusion Criteria

* • Multirooted teeth

* Teeth undergoing Re-endo treatments
* Teeth with root fractures and/ non restorable determined by clinical and radiographic examination
* Patients receiving antibiotic treatment in the past 3 months determined by history
* Patient with Diabetes determined by history
* Patient with history of smoking
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Altamash Institute of Dental Medicine

OTHER

Sponsor Role lead

Responsible Party

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Hira Abbasi

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hira Danish

Karachi, Sindh, Pakistan

Site Status

Countries

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Pakistan

Other Identifiers

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Root canal Irrigiant

Identifier Type: -

Identifier Source: org_study_id

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