NCT06172023

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 7, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 15, 2023

Completed
Last Updated

December 15, 2023

Status Verified

December 1, 2023

Enrollment Period

2.9 years

First QC Date

December 7, 2023

Last Update Submit

December 7, 2023

Conditions

Endodontic Disease

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Antimicrobial Activity Assessment

    1 hour, 24 hours, 7 days, and 30 days

Study Arms (3)

Silver Nanoparticles Irrigant

EXPERIMENTAL
Drug: Silver Nanoparticles Irrigant

Chitosan Nanoparticle Irrigant

EXPERIMENTAL
Drug: Chitosan Nanoparticles Irrigant

2.6% NaOCl and 17% EDTA sol

ACTIVE COMPARATOR
Drug: Silver Nanoparticles IrrigantDrug: Chitosan Nanoparticles Irrigant

Interventions

Silver Nanoparticles IrrigantDRUG

Nanosilver irrigant solution

2.6% NaOCl and 17% EDTA solSilver Nanoparticles Irrigant
Chitosan Nanoparticles IrrigantDRUG

Chitosan nanoparticles irrigant solution

2.6% NaOCl and 17% EDTA solChitosan Nanoparticle Irrigant

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, Minia University

Minya, 2431412, Egypt

Location

MeSH Terms

Conditions

Dental Pulp Diseases

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctorate candidate at the Faculty of Dentistry, Minia University

Study Record Dates

First Submitted

December 7, 2023

First Posted

December 15, 2023

Study Start

January 1, 2020

Primary Completion

December 1, 2022

Study Completion

March 1, 2023

Last Updated

December 15, 2023

Record last verified: 2023-12

Locations

EG(1)