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

Cairo University (CU)

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Postoperative Pain

Treatments: Drug: Sodium Hypochlorite; Drug: chitosan nanoparticles

Study type: Interventional

Funder types: Other

Identifiers

NCT03719261

Sarah mahgoub

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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24 participants in 2 patient groups

sodium hypochlorite

Active Comparator group

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

Treatment:

Drug: Sodium Hypochlorite

chitosan nanoparticles

Experimental group

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

Treatment:

Drug: chitosan nanoparticles