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

Sponsor
Altamash Institute of Dental Medicine (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05306431
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
4
Anticipated Duration (Months)
10
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Polyhexamethylene biguanide
  • Drug: Sodium Hypochlorite
 Phase 2

Detailed Description

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Masking Description:
The microbiologist will be kept blind to avoid risk of bias.
Primary Purpose:
Treatment
Official Title:
Comparison of Antimicrobial Action of Sodium Hypochlorite and Polyhexamethylene Biguanide as Root Canal Irrigants in Patients Reporting With Non-vital Necrotic Pulp and Apical Periodontitis
Actual Study Start Date :
Aug 1, 2022
Actual Primary Completion Date :
Aug 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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

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

    		•
    Experimental: 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.

    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
    Other Names:
  • Bleach

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Bacterial load assessed by culture [24 hours]

      Effectiveness of irrigant will be evaluated with the existence or non-existence of bacteria: Positive Effect = no bacteria exist, Negative Effect = bacteria exist. Bacterial analysis will be performed by counting the number of colonies of bacteria in the specimen: No growth = no colonies seen, Few growths = less than 10 colonies of bacteria seen, Moderate growth = less than 100 colonies more than 10 colonies of bacteria seen, Heavy growth = more than 100 colonies of bacteria seen.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hira Danish Karachi Sindh Pakistan 75500

    Sponsors and Collaborators

    • Altamash Institute of Dental Medicine

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hira Abbasi, Principal Investigator, Altamash Institute of Dental Medicine
    ClinicalTrials.gov Identifier:
    NCT05306431
    Other Study ID Numbers:
    • Root canal Irrigiant
    First Posted:
    Apr 1, 2022
    Last Update Posted:
    Aug 24, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Pulpitis
    Biguanides
    Sodium Hypochlorite
    Polihexanide
    Eusol

    Study Results

    No Results Posted as of Aug 24, 2022