Evaluation of Antimicrobial Efficacy and Postoperative Pain After Using Silver Nanoparticles and Chitosan Nanoparticles Against Enterococcus Faecalis and Candida Albicans Biofilm

Evaluation of Antimicrobial Efficacy and Postoperative Pain After Using Silver Nanoparticles and Chitosan Nanoparticles Against Enterococcus Faecalis and Candida Albicans Biofilm (An in Vitro - in Vivo Study)

Silver nanoparticles possess unique physicochemical and biological properties in addition to their antibacterial capabilities. Similarly, zinc oxide nanoparticles have demonstrated antibacterial effects against a wide range of bacteria, including heat and pressure resistant spores. Given these characteristics, it would be valuable to evaluate and compare a new irrigation solution containing nanosilver and nanozinc-oxide particles with sodium hypochlorite. Furthermore, Chitosan Nanoparticles are expected to exhibit enhanced antibacterial activity compared to regular-sized Chitosan due to their ability to penetrate and disrupt microbial cell membranes. Consequently, the current study aims to assess and compare the antibacterial activity of Silver Nanoparticles and Chitosan Nanoparticles, as well as their impact on post-operative pain.

Study Overview

• Status: Completed
• Conditions: Endodontic Disease
• Intervention / Treatment: Drug: Silver Nanoparticles Irrigant; Drug: Chitosan Nanoparticles Irrigant

• Study Type: Interventional
• Enrollment (Actual): 78
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Minya, Egypt, 2431412
    • Faculty of Dentistry, Minia University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Medically stable healthy patients (category: American society of anesthesiologists class I).
• The patient ranges in age from 20 to 40.
• No sexual orientation
• Necrotic pulp evaluated by thermal or electrical pulp testing.
• Enough crown structure to provide adequate isolation.
• One root and one canal.
• Patients' desire to engage in this research.
• Patients' comprehension of the visual analogue scale (VAS).
• Patients' ability to sign informed consent.

Exclusion Criteria:

• Endodontic treatment for the tooth previously.
• Teeth with poor conditions for using rubber dams.
• Vital pulp tissue was observed throughout the treatment.
• Patients who have a medical condition.
• Teeth with open apices that are immature
• Women who are pregnant or breastfeeding.
• Psychologically disturbed patients.
• Patients having a history of allergy to any of the research drugs were barred from participation.
• A periodontally affected tooth with grade 2 or 3 mobility.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Silver Nanoparticles Irrigant	Drug: Silver Nanoparticles Irrigant; Nanosilver irrigant solution
Experimental: Chitosan Nanoparticle Irrigant	Drug: Chitosan Nanoparticles Irrigant; Chitosan nanoparticles irrigant solution
Active Comparator: 2.6% NaOCl and 17% EDTA sol	Drug: Silver Nanoparticles Irrigant; Nanosilver irrigant solution; Drug: Chitosan Nanoparticles Irrigant; Chitosan nanoparticles irrigant solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Pain Assessment	Each patient was given a pain scale chart (VAS scale) before every endodontic operation to record his or her pain level. The VAS is a 10-point scale with values ranging from 0 to 10, with 0 representing "No pain," (1-3) representing "mild pain," (4-6) representing "moderate pain," and (7-10) representing "worst imaginable pain." At 6, 12, 24, 48, and 72 hours, each patient was instructed to use the VAS scale (0-10) to rate the presence and severity of discomfort after obturation.	6, 12, 24, 48, and 72 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Antimicrobial Activity Assessment	A sterile paper point was placed in each root canal to a level roughly 1 mm short of the apex, depending on working length radiographs, to get a sample from the root canal. The samples were suspended in a suspension of 25 microliters, which was pipetted onto a BHI agar plate. The colonies were counted using a Reichert-Jung colony counter after 1 hour, 24 hours, 7 days, and 30 days of incubation at 37oC in an anaerobic jar.	1 hour, 24 hours, 7 days, and 30 days

Collaborators and Investigators

• Sponsor: Minia University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Actual): December 1, 2022
• Study Completion (Actual): March 1, 2023

Study Registration Dates

• First Submitted: December 7, 2023
• First Submitted That Met QC Criteria: December 7, 2023
• First Posted (Actual): December 15, 2023

Study Record Updates

• Last Update Posted (Actual): December 15, 2023
• Last Update Submitted That Met QC Criteria: December 7, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Stomatognathic Diseases; Tooth Diseases; Pain, Postoperative; Dental Pulp Diseases; Molecular Mechanisms of Pharmacological Action; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hemostatics; Coagulants; Chelating Agents; Sequestering Agents; Chitosan
• Other Study ID Numbers: (RHDIRB2017122004) (438)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No