Antimicrobial Efficacy of Nano-Based ICM on E.F

NCT06533215 | Recruiting

• 1 other identifier: Nano-Based ICM on E.F
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This in-vivo study aims to evaluate the antimicrobial effect of nano based intracanal medications (Triple antibiotic-loaded chitosan nanoparticles and chlorohexidine loaded by silver nanoparticles) on Enterococcus faecalis count reduction in secondary endodontic infection cases.

Conditions

Enterococcus Faecalis Infection; Endodontically Treated Teeth; Endodontic Disease

Keywords

intracanal medication; Enterococcus Faecalis; secondary endodontic infection cases.

Outcome Measures

Primary Outcomes (1)

• the total numbers of Enterococcus Faecalis bacteria on bile esculin agar

  colony forming units (CFU/ml).

  one weak after application of intracanal medication

Secondary Outcomes (1)

• Post operative pain

  one weak after application of intracanal medication

Study Arms (3)

Group 1: Chlorohexidine (CHX) gel.

ACTIVE COMPARATOR

Application of Chlorohexidine intracanal medication in secondry endodontic infection cases

Other: antimicrobial efficacy of nano based intracanal medications on Enterococcus faecalis count reduction in secondary endodontic infection cases.

Group 2: Chlorohexidine loaded by silver nanoparticles (Ag-np) gel.

ACTIVE COMPARATOR

Application of chlorohexidine loaded by silver nanoparticles (Ag-np) gel intracanal medication in secondry endodontic infection cases

Other: antimicrobial efficacy of nano based intracanal medications on Enterococcus faecalis count reduction in secondary endodontic infection cases.

Group 3: Triple antibiotic-loaded chitosan nanoparticles (tachnp) gel.

ACTIVE COMPARATOR

Application of triple antibiotic-loaded chitosan nanoparticles (tachnp) gelintracanal medication in secondry endodontic infection cases

Other: antimicrobial efficacy of nano based intracanal medications on Enterococcus faecalis count reduction in secondary endodontic infection cases.

Interventions

antimicrobial efficacy of nano based intracanal medications on Enterococcus faecalis count reduction in secondary endodontic infection cases. OTHER

The paper points of three samples (S1, S2, and S3) will be placed each in a sterile falcon tube containing 1ml of brain heart infusion and labeled according to the type of intracanal medication used. Samples will be homogenized by the vortex and and one micron of each sample will be cultured on Bile Esculin Agar for E. faecalis. The plate will be labeled as the tube of the same sample and incubated at 37οC for 24-48 h and then after incubation, the total numbers of E.faecalis will be counted and calculated to get the colony forming units (CFU/ml).

Also known as: Microbiological count

Group 1: Chlorohexidine (CHX) gel.; Group 2: Chlorohexidine loaded by silver nanoparticles (Ag-np) gel.; Group 3: Triple antibiotic-loaded chitosan nanoparticles (tachnp) gel.

Eligibility Criteria

• Age: 19 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Single rooted, single canal premolar teeth.
• Teeth indicated for non-surgical root canal retreatment.
• Teeth have signs and/or symptoms of post-treatment disease manifested by recurrent acute and/or chronic periapical abscess.
• Teeth have clinical signs and symptoms of endodontic failure as sensitivity to percussion, pain, swelling or fistula.
• Teeth with radiographic features of endodontic failure as persistent periapical lesion or widening of periodontal ligament.
• Symptomatic or asymptomatic teeth with short root canal filling indicated for prosthetic restoration

You may not qualify if:

• Patients with any systemic diseases.
• Pregnant or lactating patients.
• Immunocompromised patients.
• Non-restorable tooth.
• Calcified root canal.
• Teeth with root fracture.
• Teeth with periodontal pocket deeper than 4mm.
• Teeth have procedural error like ledge, broken instrument, or perforation

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Faculty of Dentistry

Tanta, Egypt

RECRUITING

Related Publications (2)

• Fahim MM, Saber SEM, Elkhatib WF, Nagy MM, Schafer E. The antibacterial effect and the incidence of post-operative pain after the application of nano-based intracanal medications during endodontic retreatment: a randomized controlled clinical trial. Clin Oral Investig. 2022 Feb;26(2):2155-2163. doi: 10.1007/s00784-021-04196-w. Epub 2021 Oct 25.

  PMID: 34697657 BACKGROUND

• Shaik J, Garlapati R, Nagesh B, Sujana V, Jayaprakash T, Naidu S. Comparative evaluation of antimicrobial efficacy of triple antibiotic paste and calcium hydroxide using chitosan as carrier against Candida albicans and Enterococcus faecalis: An in vitro study. J Conserv Dent. 2014 Jul;17(4):335-9. doi: 10.4103/0972-0707.136444.

  PMID: 25125845 BACKGROUND

MeSH Terms

Conditions

Tooth, Nonvital; Dental Pulp Diseases

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Officials

• Abeer Darrag, Phd

  Professor of Endodontics

  PRINCIPAL INVESTIGATOR

• Dina Ali, phd

  Lecturer of Endodontics

  STUDY DIRECTOR

• Radwa Abd Elmotaleb Eissa, phd

  Ass.professor of Microbiology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ibrahim Ali, bachelor

CONTACT

+201021294204; ibrahim3lii1995@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor

Study Record Dates

• First Submitted: July 30, 2024
• First Posted: August 1, 2024
• Study Start: January 2, 2024
• Primary Completion: February 2, 2025
• Study Completion: March 2, 2025
• Last Updated: August 1, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)