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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-30

Study Completion Date

2019-10-31

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.

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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.

Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

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

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Sodium Hypochlorite

Intervention Type DRUG

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 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

Group Type EXPERIMENTAL

chitosan nanoparticles

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

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

Intervention Type DRUG

Other Intervention Names

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chitosan

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes