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Clinical trial

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

ID
Name
Root canal Irrigiant
Description
The aim of this randomized clinical trial is to compare the antibacterial effects of sodium hypochlorite (NaOCl) and Polyhexamethylene biguanide during root canal treatment .
Trial arms
Trial start
2022-06-01
Estimated PCD
2022-06-01
Trial end
2022-11-30
Status
Completed
Phase
Early phase I
Treatment
Polyhexamethylene biguanide
Polyhexamethylene biguanide (PHMB), is a disinfectant solution having a broad spectrum of antimicrobial activity and is investigated as an endodontic irrigant
Arms:
Polyhexamethylene biguanide
Other names:
PHMB
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
Arms:
Sodium Hypochloride
Other names:
Bleach
Size
60
Primary endpoint
Bacterial load assessed by culture
24 hours
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'The microbiologist will be kept blind to avoid risk of bias.', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 60, 'type': 'ACTUAL'}}
Updated at
2023-02-21

1 organization

2 products

1 indication

Organization
Altamash Institute of Dental Medicine
Product
Polyhexamethylene biguanide
Indication
Pulpitis
Product
Sodium Hypochlorite