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Completed

NCT Number: NCT06172023

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

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.

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Key information

Conditions

Endodontic Disease Dental Pulp Diseases Stomatognathic Diseases Tooth Diseases

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Minia University

Minya, 2431412, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Silver Nanoparticles Irrigant

Drug

Nanosilver irrigant solution

Chitosan Nanoparticles Irrigant

Drug

Chitosan nanoparticles irrigant solution

Primary outcomes

  1. Postoperative Pain Assessment

    Time frame: 6, 12, 24, 48, and 72 hours

    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.

Secondary outcomes

  1. Antimicrobial Activity Assessment

    Time frame: 1 hour, 24 hours, 7 days, and 30 days

    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.

Sponsors and collaborators

Lead sponsor

Minia University

Other

Registry information

Official study 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)

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Dec 15, 2023
Registry last updated
Dec 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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