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.
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
- Conditions the study is for
- Enterococcus Faecalis Infection, Endodontically Treated Teeth, Endodontic Disease
- 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.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dentistry
Tanta
Ahmed salim, +201559959130
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 group | Role | What they receive |
|---|---|---|
| Group 1: Chlorohexidine (CHX) gel. | Active comparator | Application 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 comparator | Application 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 comparator | Application 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.
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)
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.
- First posted1 Aug 2024
- Study start2 Jan 2024
- Primary completion2 Feb 2025 (estimated)
- Study completion2 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Enterococcus Faecalis InfectionStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ibrahim Ali Eissa, Tanta University
- Investigators
- Abeer Darrag, Phd, Principal investigator, Professor of EndodonticsDina Ali, phd, Study director, Lecturer of EndodonticsRadwa Abd Elmotaleb Eissa, phd, Principal investigator, Ass.professor of Microbiology
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 34697657Shaik 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
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antimicrobial Efficacy of Nano-Based Intracanal Medications on Enterococcus Faecalis
- ClinicalTrials.gov ID
- NCT06533215
- Acronym / sponsor ID
- Nano-Based ICM on E.F
- Keywords
- intracanal medication, Enterococcus Faecalis, secondary endodontic infection cases.
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 2 Jan 2024 (actual)
- Primary completion
- 2 Feb 2025 (estimated)
- Study completion
- 2 Mar 2025 (estimated)
- First posted
- 1 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1: Chlorohexidine (CHX) gel. | Active comparator | Other: antimicrobial efficacy of nano based intracanal medications on Enterococcus faecalis count reduction in secondary endodontic infection cases.Application of Chlorohexidine intracanal medication in secondry endodontic infection cases |
| Group 2: Chlorohexidine loaded by silver nanoparticles (Ag-np) gel. | Active comparator | Other: antimicrobial efficacy of nano based intracanal medications on Enterococcus faecalis count reduction in secondary endodontic infection cases.Application of chlorohexidine loaded by silver nanoparticles (Ag-np) gel intracanal medication in secondry endodontic infection cases |
| Group 3: Triple antibiotic-loaded chitosan nanoparticles (tachnp) gel. | Active comparator | Other: antimicrobial efficacy of nano based intracanal medications on Enterococcus faecalis count reduction in secondary endodontic infection cases.Application of triple antibiotic-loaded chitosan nanoparticles (tachnp) gelintracanal medication in secondry endodontic infection cases |
Who may qualify
- Ages
- 19 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- Patients with any systemic diseases.
- Pregnant or lactating patients.
- Immunocompromised patients.
- Non-restorable tooth.
- Calcified root canal.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| antimicrobial efficacy of nano based intracanal medications on Enterococcus faecalis count reduction in secondary endodontic infection cases.Also: Microbiological countThe 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). | Other | Group 1: Chlorohexidine (CHX) gel., Group 2: Chlorohexidine loaded by silver nanoparticles (Ag-np) gel., Group 3: Triple antibiotic-loaded chitosan nanoparticles (tachnp) gel. |
Primary outcome
the total numbers of Enterococcus Faecalis bacteria on bile esculin agar
Time frame: one weak after application of intracanal medication
colony forming units (CFU/ml).
1 secondary outcome
Post operative pain
Time frame: one weak after application of intracanal medication
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2024.
- Background: PubMed 34697657Fahim 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.
- Background: PubMed 25125845Shaik 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abeer Darrag, Phd principal investigator
Professor of Endodontics
Dina Ali, phd study director
Lecturer of Endodontics
Radwa Abd Elmotaleb Eissa, phd principal investigator
Ass.professor of Microbiology
1 site in 1 country: see every site and its status.
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.