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

NCT05306431 | Completed Phase 2

• 1 other identifier: Root canal Irrigiant
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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 .

Conditions

Irreversible Pulpitis

Outcome Measures

Primary Outcomes (1)

• 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.

  24 hours

Study Arms (2)

Polyhexamethylene biguanide

EXPERIMENTAL

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

Sodium Hypochloride

EXPERIMENTAL

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

Interventions

Polyhexamethylene biguanide DRUG

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

Also known as: PHMB

Polyhexamethylene biguanide

Sodium Hypochlorite 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

Also known as: Bleach

Sodium Hypochloride

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Altamash Institute of Dental Medicine: lead

Study Sites (1)

Hira Danish

Karachi, Sindh, 75500, Pakistan

Location

MeSH Terms

Interventions

polihexanide; Sodium Hypochlorite

Intervention Hierarchy (Ancestors)

Hypochlorous Acid; Chlorine Compounds; Inorganic Chemicals; Oxides; Oxygen Compounds; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The microbiologist will be kept blind to avoid risk of bias.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 19, 2022
• First Posted: April 1, 2022
• Study Start: June 1, 2022
• Primary Completion: June 1, 2022
• Study Completion: November 30, 2022
• Last Updated: February 21, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)