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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05306431
Enrollment
60
Registered
2022-04-01
Start date
2022-06-01
Completion date
2022-11-30
Last updated
2023-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Irreversible Pulpitis

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.

Interventions

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

DRUGSodium 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

Sponsors

Altamash Institute of Dental Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Bacterial load assessed by culture24 hoursEffectiveness 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.

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026