Assessment of Pain and Antibacterial Activity of Chitosan Versus Sodium Hypochlorite as Irrigant in Infected Canal

Phase 2

• Conditions: Postoperative Pain
• Interventions: Drug: Sodium Hypochlorite; Drug: chitosan nanoparticles

• Registration Number: NCT03719261
• Lead Sponsor: Cairo University

Brief Summary

A randomized clinical trial that aims to study the effect of chitosan nanoparticles (CS-np) versus sodium hypochlorite as a root canal irrigant on postoperative pain and antibacterial activity against E.faecalis in infected root canal.

Detailed Description

This trial aims to study the effect of chitosan nanoparticles (CS-np) versus sodium hypochlorite as a root canal irrigant on postoperative pain and antibacterial activity against E.faecalis in infected root canal. initial pre-treatment root canal sample will be taken.These will be designated as sample no.1. after first sample, according to random sequence, the patients will be randomly assigned into two groups. In Group I: Sodium hypochlorite (NaOCL 2.5%) will be used during instrumentation of the canals.In Group II: chitosan nanoparticles (CS-np) will be used. after preparation, the sample no.2 will be taken.Pain will be assessed by giving the patient the numerical pain rating scale (NRS) to assess his pain at 24, 48 and 72 hours after the first visit.

Study Timeline

• Status Verified: 2018-10
• Study First Submitted: 2018-10-20
• Study First Submitted QC: 2018-10-23
• Last Update Submitted: 2018-10-23
• Study First Posted: 2018-10-25
• Last Update Posted: 2018-10-25
• Study Start: 2018-11
• Primary Completion: 2019-04
• Study Completion: 2019-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Young adult Patients, both genders, aging from 18-45 years.
• Patients with permanent mature teeth (closed apex).
• Single rooted single canal necrotic anterior teeth without apical periodontitis or with slight widening of peridontium.
• Patients should be free from any systemic disease.
• Patients with normal periodontal depth less or equal 3 mm.
• Patients who will agree to the consent and will commit to follow-up.

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Exclusion Criteria

• Patients with permanent immature teeth.
• Teeth with vital pulps.
• Patients with facial swelling or acute infection or pain on percussion
• Patients with fistula.
• Teeth with vertical root fractures, internal or external root resorption and calcification
• Teeth with periodontal involvement or periapical bone loss.
• Patients with any systemic disease that may affect predictable outcome.
• Pregnant or lactating females.
• Non-restorable teeth.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sodium hypochlorite	Sodium Hypochlorite	Sodium hypochlorite (NaOCL) is the most recommended irrigant due to its broad antibacterial effect, necrotic tissues and dentin collagen dissolving capability and inactivation of endotoxins.10ml of 2.5%NaOCL will be used during instrumentation in control group
chitosan nanoparticles	chitosan nanoparticles	Chitosan is a bioactive polymer obtained from deacetylation of chitin and is used in biomedical application due to its antimicrobial properties and biocompatibility and ability to resist aging for longer periods provide antibacterial effect in root canal disinfection.10ml of cs-np will be used during instrumentation in intervention group

Primary Outcome Measures

Name	Time	Method
antibacterial activity	two samples will be taken at the same visit of endodontic treatment at day 1, the outcome measures will be assessed after 24h. the data will be reported after study compeletion about 1 year	antibacterial activity will be evaluated by Sampling and culture method. The samples will be subjected to microbiological analysis to ascertain their individual microbiological load after 24h, this will be analyzed by counting the colony forming units (CFUs).