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

NCT03719261 | Unknown Phase 2 DMC

• 1 other identifier: Sarah mahgoub
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

sodium hypochlorite

ACTIVE COMPARATOR

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

chitosan nanoparticles

EXPERIMENTAL

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

Interventions

chitosan nanoparticles 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

Also known as: chitosan

chitosan nanoparticles

Sodium Hypochlorite 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

sodium hypochlorite

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Chitosan; Sodium Hypochlorite

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chitin; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Hypochlorous Acid; Chlorine Compounds; Inorganic Chemicals; Oxides; Oxygen Compounds; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Double blinded The patient is also outcome assessor will be blinded as well as data analyst person.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: phD student

Study Record Dates

• First Submitted: October 20, 2018
• First Posted: October 25, 2018
• Study Start: November 1, 2018
• Primary Completion: April 1, 2019
• Study Completion: October 1, 2019
• Last Updated: October 25, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share