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

Irreversible Pulpitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05306431
• Other study ID #: Root canal Irrigiant
• Status: Completed
• Phase: Phase 2
• Start date: June 1, 2022
• Est. completion date: November 30, 2022

Study information

• Verified date: February 2023
• Source: Altamash Institute of Dental Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 30, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Irreversible Pulpitis
• Pulpitis

Intervention

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

Locations

Country	Name	City	State
Pakistan	Hira Danish	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
Altamash Institute of Dental Medicine

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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