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

Endodontic Disease Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06172023
• Other study ID #: (RHDIRB2017122004) (438)
• Status: Completed
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: March 1, 2023

Study information

• Verified date: December 2023
• Source: Minia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: March 1, 2023
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Pulp Diseases
• Endodontic Disease
• Pain, Postoperative

Intervention

Drug:
• Silver Nanoparticles Irrigant
Nanosilver irrigant solution
• Chitosan Nanoparticles Irrigant
Chitosan nanoparticles irrigant solution

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry, Minia University	Minya

Sponsors (1)

Lead Sponsor	Collaborator
Minia University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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