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

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

Sponsors

Lead Sponsor: Cairo University

Source 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.

Overall Status Unknown status
Start Date 2018-11-01
Completion Date 2019-10-01
Primary Completion Date 2019-04-01
Phase Phase 2/Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
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
Enrollment 24
Condition
Intervention

Intervention Type: Drug

Intervention Name: chitosan nanoparticles

Description: 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

Arm Group Label: chitosan nanoparticles

Other Name: chitosan

Intervention Type: Drug

Intervention Name: Sodium Hypochlorite

Description: 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

Arm Group Label: sodium hypochlorite

Eligibility

Criteria:

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.

Gender:

All

Minimum Age:

18 Years

Maximum Age:

45 Years

Healthy Volunteers:

Accepts Healthy Volunteers

Verification Date

2018-10-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Cairo University

Investigator Full Name: sarah mahgoub

Investigator Title: phD student

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: sodium hypochlorite

Type: Active Comparator

Description: 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

Label: chitosan nanoparticles

Type: Experimental

Description: 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

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Double (Participant, Outcomes Assessor)

Masking Description: Double blinded The patient is also outcome assessor will be blinded as well as data analyst person.

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