Back to resultsComparison of Antimicrobial Action of Sodium Hypochlorite and Polyhexamethylene Biguanide as Root Canal Irrigants
Primary Purpose
Irreversible Pulpitis
Status
Completed
Phase
Phase 2
Locations
Pakistan
Study Type
Interventional
Intervention
Polyhexamethylene biguanide
Sodium Hypochlorite
Sponsored by
About this trial
This is an interventional treatment trial for Irreversible Pulpitis
Eligibility Criteria
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
Sites / Locations
- Hira Danish
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Polyhexamethylene biguanide
Sodium Hypochloride
Arm Description
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
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.
Outcomes
Primary Outcome Measures
Bacterial load assessed by culture
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05306431
First Posted
March 19, 2022
Last Updated
February 20, 2023
Sponsor
Altamash Institute of Dental Medicine
1. Study Identification
Unique Protocol Identification Number
NCT05306431
Brief Title
Comparison of Antimicrobial Action of Sodium Hypochlorite and Polyhexamethylene Biguanide as Root Canal Irrigants
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
June 1, 2022 (Actual)
Study Completion Date
November 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Altamash Institute of Dental Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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 .
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irreversible Pulpitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
The microbiologist will be kept blind to avoid risk of bias.
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Polyhexamethylene biguanide
Arm Type
Experimental
Arm Description
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
Arm Title
Sodium Hypochloride
Arm Type
Experimental
Arm Description
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
Intervention Name(s)
Polyhexamethylene biguanide
Other Intervention Name(s)
PHMB
Intervention Description
Polyhexamethylene biguanide (PHMB), is a disinfectant solution having a broad spectrum of antimicrobial activity and is investigated as an endodontic irrigant
Intervention Type
Drug
Intervention Name(s)
Sodium Hypochlorite
Other Intervention Name(s)
Bleach
Intervention Description
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
Primary Outcome Measure Information:
Title
Bacterial load assessed by culture
Description
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.
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Hira Danish
City
Karachi
State/Province
Sindh
ZIP/Postal Code
75500
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparison of Antimicrobial Action of Sodium Hypochlorite and Polyhexamethylene Biguanide as Root Canal Irrigants
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