Clinical trial

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)

Name
(RHDIRB2017122004) (438)
Description
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.
Trial arms
Trial start
2020-01-01
Estimated PCD
2022-12-01
Trial end
2023-03-01
Status
Completed
Treatment
Silver Nanoparticles Irrigant
Nanosilver irrigant solution
Arms:
2.6% NaOCl and 17% EDTA sol, Silver Nanoparticles Irrigant
Chitosan Nanoparticles Irrigant
Chitosan nanoparticles irrigant solution
Arms:
2.6% NaOCl and 17% EDTA sol, Chitosan Nanoparticle Irrigant
Size
78
Primary endpoint
Postoperative Pain Assessment
6, 12, 24, 48, and 72 hours
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 78, 'type': 'ACTUAL'}}
Updated at
2023-12-15

1 organization

2 products

1 indication

Organization
Minia University