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Enterococcus Faecalis InfectionNCT06533215

Antimicrobial Efficacy of Nano-Based ICM on E.F

A study testing antimicrobial efficacy of nano based intracanal medications on Enterococcus faecalis count reduction in secondary endodontic infection cases. in people with Enterococcus Faecalis Infection and Endodontically Treated Teeth, run by Tanta University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 to 60 yearsHealthy volunteers can take part
What is being tested?
antimicrobial efficacy of nano based intracanal medications on Enterococcus faecalis count reduction in secondary endodontic infection cases.
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteEgypt
Study dates
2 Jan 2024to 2 Mar 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Ibrahim Ali, bachelor contact

+201021294204

ibrahim3lii1995@gmail.com

Egypt1 site, 1 recruiting
  • Faculty of Dentistry

    Tanta

    Ahmed salim, +201559959130

    Recruiting

Other trials in Egypt

About this study

Official title: Antimicrobial Efficacy of Nano-Based Intracanal Medications on Enterococcus Faecalis

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.

Read the detailed description

Success of root canal treatment is largely dependent on the elimination of harmful microorganisms and primarily bacteria from the root canal system through chemomechanical preparation and using intracanal medication in order to cure or prevent periapical disease and allowing the maintenance of the dental element.

Failure of endodontically treated teeth is multifactorial; it is believed that the most important reason for endodontic treatment failure is the presence of microorganisms in the apical third of the root canal that survive after endodontic procedures.

Enterococcus faecalis (E. faecalis) is among the most commonly isolated bacteria from the failed endodontically treated root canals. Enterococcus is a facultative anaerobic gram-positive coccus that invades dentinal tubules, can survive in alkaline environment, endure prolonged periods of starvation, and have certain virulence factors and lytic enzymes. Its prevalence in primary endodontic infection ranges from 4% to 40 % and secondary endodontic infection ranges from 24% to 77%.

Moreover, anatomical complexity and diversity of root canals that hinders a complete disinfection of root canal space by chemo-mechanical instrumentation alone. So, the use of an intracanal medication remains an important adjunct to complete elimination of remaining bacteria by reaching areas that instruments and irrigation could not reach in addition to long-standing infections.

So, using of intracanal medication is mandatory in infected endodontic cases as more thorough debridement is achieved because of the longer overall time used for the treatment.It prevents regrowth of the remaining microbiota within the root canal system and also to increase the level of disinfection.

Chlorohexidine (CHX) is an intracanal medication that has an antibacterial effect plus high substantivity which leads to a prolonged action; however it isn't able to eradicate bacteria completely from root canals.

Triple antibiotic paste (TAP) is a combination of metronidazole, ciprofloxacin, and minocycline. This combination is able to remove diverse groups of obligate and facultative gram-positive and gram-negative bacteria, providing an environment for healing. So, this allows disinfection, and possible sterilization of the root canal system.

Introduction of nanotechnology in dentistry has been developed by using nanoparticles (NPs) exclusive features that include smaller sizes and increased surface area to volume ratio. They have higher chemical reactivity and charge density leading to greater interaction with the environment and negatively charged bacterial cells, compared to their bulk counterparts. These advantages may be used to design highly anti-microbial agents with maximal therapeutic efficacy and minimal side effects.

Intracanal medications in the nano-form can achieve optimal therapeutic activity through their interaction with microorganisms at both the sub-cellular and molecular levels. Because of their small size, they can penetrate well into the complex anatomy of the root canal system.

Chlorohexidine and triple antibiotic paste cannot be converted into nanosized forms, they can be loaded with other nanosized materials like silver and chitosan nanoparticles to gain the benefit of both materials and become nanoparticulate.

The triple antibiotic was utilized together with chitosan as a vehicle to increase its stability and controlled release of the medicament. Triple antibiotic-loaded chitosan nanoparticles (tachnp) paved the way for the use of chitosan which has an excellent antiviral, antifungal and antibacterial properties.

On the other hand, Chlorohexidine loaded by silver nanoparticles (Ag-np) had high antimicrobial efficacy which is due to the dual antibacterial effect of Ag-np and chlorohexidine, it also allowed the use of silver nanoparticles which are known for their ability to destabilize the bacterial cell membrane and increase its permeability which leads to bacterial death.

According to the current knowledge, there is limited information concerning the efficacy of different new combinations of intracanal medications on bacterial count reduction of retreatment cases. Therefore, the purpose of the present study is to evaluate the antimicrobial effect of nano-based intracanal medications on Enterococcus Faecalis in secondary endodontic infection cases.

Being tested
antimicrobial efficacy of nano based intracanal medications on Enterococcus faecalis count reduction in secondary endodontic infection cases.
Keywords
intracanal medication, Enterococcus Faecalis, secondary endodontic infection cases.
Medical subject headings
Tooth, Nonvital, Dental Pulp Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    Also called Microbiological count

    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).

Study groups in NCT06533215
Study groupRoleWhat they receive
Group 1: Chlorohexidine (CHX) gel.Active comparatorApplication of Chlorohexidine intracanal medication in secondry endodontic infection cases
Receives: 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 comparatorApplication of chlorohexidine loaded by silver nanoparticles (Ag-np) gel intracanal medication in secondry endodontic infection cases
Receives: 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 comparatorApplication of triple antibiotic-loaded chitosan nanoparticles (tachnp) gelintracanal medication in secondry endodontic infection cases
Receives: Other: antimicrobial efficacy of nano based intracanal medications on Enterococcus faecalis count reduction in secondary endodontic infection cases.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. the total numbers of Enterococcus Faecalis bacteria on bile esculin agar

    colony forming units (CFU/ml).

    Measured: one weak after application of intracanal medication

Secondary outcomes (1)
  1. Post operative pain

    pain on his own words

    Measured: one weak after application of intracanal medication

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Aug 2024
  2. Study start2 Jan 2024
  3. Primary completion2 Feb 2025 (estimated)
  4. Study completion2 Mar 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06533215
Sponsor's protocol ID
Nano-Based ICM on E.F
Status last verified
Jul 2024
First submitted
30 Jul 2024
Last updated
1 Aug 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 34697657
  • 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.

    PubMed 25125845

Questions about this trial

What is this clinical trial studying?

A study testing antimicrobial efficacy of nano based intracanal medications on Enterococcus faecalis count reduction in secondary endodontic infection cases. in people with Enterococcus Faecalis Infection and Endodontically Treated Teeth, run by Tanta University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 1 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ibrahim Ali, bachelor (+201021294204, ibrahim3lii1995@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

the total numbers of Enterococcus Faecalis bacteria on bile esculin agar (time frame: one weak after application of intracanal medication). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06533215, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2024.

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