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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Assessment of Postoperative Pain and Antibacterial Activity of Chitosan Nanoparticles Versus Sodium Hypochlorite as a Root Canal Irrigant in Infected Root Canal

Conditions
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Postoperative Pain

Intervention / Treatment
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* Drug: chitosan nanoparticles
* Drug: Sodium Hypochlorite


Participation Criteria
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Eligibility Criteria
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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. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: sodium hypochlorite<br>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 | Drug: Sodium Hypochlorite<br>* 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<br>|
| Experimental: chitosan nanoparticles<br>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 | Drug: chitosan nanoparticles<br>* 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<br>* Other names: chitosan;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| antibacterial activity | 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). | 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 |