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Bacterial Infections OralNCT05475444

PLGA Nanoparticles Entrapping Ciprofloxacin to Treat E-Fecalis Infections in Endodontics

A study testing Chitosan Coated PLGA nanoparticles entrapping Ciprofloxacin incorporated in smart gels and Ciprofloxacin paste and solution in people with Bacterial Infections Oral, run by British University In Egypt at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

PLGA nanoparticles coated with Chitosan polymer were prepared and then incorporated in In -situ gel to be injected to root canals of patients suffered from bacterial infection of their endodontics. Read more about this study

Who is it for?
Any age
Conditions the study is for
Bacterial Infections Oral
What is being tested?
Chitosan Coated PLGA nanoparticles entrapping Ciprofloxacin incorporated in smart gels and Ciprofloxacin paste and solution
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55 participants
Where
1 siteEgypt
Study dates
1 Mar 2020to 15 Mar 2020
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Root canal filled single rooted teeth with post treatment disease manifested by one or more of the following signs and symptoms:
  • History of recurrent acute and/or chronic periapical abscess
  • Pain on palpation and/or percussion at least after one month of previous procedure
  • Radiographic evidence of bone loss either as a new developing lesion or an increase in the size of a pre-existing one.

Who cannot join

  • Teeth that were badly broken down indicated for extraction or with difficult isolation
  • Immuno-compromised patients.
  • Patients with history of taking antibiotics orally.
  • Periodontally affected teeth.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Mona Arafa

    Cairo, El Sherouk City , Suez Desert Road , Cairo - P.O. Box 43, 11837

Other trials in Egypt

About this study

Official title: Modified Surface of PLGA Nanoparticles in Smart Hydrogel: A Randomized Clinical Trial to Establish an Advanced Strategy Against Antibiotic Resistant Infections in Endodontics

PLGA nanoparticles coated with Chitosan polymer were prepared and then incorporated in In -situ gel to be injected to root canals of patients suffered from bacterial infection of their endodontics.

Read the detailed description

The Clinical procedures:

  1. First visit Treatment plan was discussed with the patients and their acceptance to participate in the study was obtained through an informed consent. Coronal restorations and any carious decay were removed, teeth properly restored then rubber dam was applied for isolation. An access cavity was prepared using an appropriate size bur (Bur #3, Veterinary dental equipment, UK) , and the tooth surface was disinfected before entering the root canals using 2.5% sodium hypochlorite, then its effect was inhibited using 5% sodium thiosulphate. The old gutta percha was removed from the coronal two thirds of the root canal using bur #3 without using any solvent. Sterile saline was used for irrigation. Patency was obtained using manual k files #15 (and #10, tooth length was determined using an electronic apex locator (Electronic apex locator J Morita Root ZX, Morita Corporation, Japan). The remaining gutta percha was removed using gradually increasing sizes of manual k files (K- files, Mani, Japan) . Scrubbing of the walls using manual files was done to soak the irrigant (sterile saline) with parts of the bacterial film on the canal walls. Sterile paper point equivalent to the size of largest file reaching the working length was placed for one minute in the canal and located one millimeter away from the tooth length, this represented the first sample for bacteriological assessment (S1) then paper point was placed in 1ml sterile medium. Complete cleaning and shaping of the canal was done using 15 ml of 2.5% sodium hypchlorite as an irrigant with a side vented needle of gauge 27, placed one millimeter from the working length and manual k type files, the master apical file was determined according to each case, where its size was increased 3 times more than the initial file with obtained white dentine chips as well. After complete cleaning and shaping, the action of sodium hypochlorite was inhibited by using 10 ml of 5% sodium thiosulphate. Sodium thiosulphate was flushed from the canal using 5 ml sterile saline. A sterile paper point equivalent to the size of master apical file was placed for one minute in the canal, one millimeter away from the working length to soak the fluid and this represented the second sample for bacteriological assessment (S2), afterwards, paper point is placed in 1ml sterile medium, then the patients were randomly allocated according to the use of an intracanal medications to the five groups for 7 days. Finally, a cotton pellet and temporary filling (Orafill-G) was applied under complete aseptic conditions
  2. Second visit
  • Assessment of the clinical signs and symptoms was done.
  1. Clinical criteria for healing:
  2. No pain with percussion 2. No pain with palpation 3. Tooth asymptomatic and functional If the patient showed these clinical findings, root canals were obturated. If the patient had all or one of them, cleaning, shaping and medication steps were repeated and the patient re-scheduled for another visit after 7 days. If the patient was asymptomatic and the tooth was functional, then a temporary filling was removed under rubber dam isolation. Twenty ml of sterile saline was used to remove the intracanal medicaments until it got out clear from the canal then sterile paper point was placed in the canal one millimeter away from the working length to take the last sample (S3), paper point was placed in 1ml sterile medium, finally master cone adjustment and obturation were done.

These sterile paper points with three samples (S1, S2, S3) were placed separately in sterile falcon tubes, labeled according to the type of medication and the order of the sample. One ml of sterile tryptic soy broth (TSB) supplemented with 0.5% glucose (TSBG) was added to each tube , then tubes were transferred to the microbiology lab within 2-3 hours from sampling procedure in an ice box 4.Microbiological evaluation All microbiological steps were performed in the vicinity of a trilaminar flow cabinet to avoid air contamination of the samples.

  1. Total percentage of bacterial reduction: A total of 100 μl from each sample containing (4mg) drug in addition to Ca (OH)2 paste and (4mg) CIP past were aspirated using a sterile micropipette from each tube. A sterile inoculum was used to add samples to the brain heart media. The samples were labeled according to the groups of medication and incubated for 24 hours at 37 ºC. After incubation, the total number of bacterial counts was estimated
Being tested
Chitosan Coated PLGA nanoparticles entrapping Ciprofloxacin incorporated in smart gels, Ciprofloxacin paste and solution

What participants receive

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

  • Chitosan Coated PLGA nanoparticles entrapping Ciprofloxacin incorporated in smart gelsDevice

    Also called Chitosan Coated PLGA nanoparticles, PLGA nanoparticles as smart gels

    antibacterial nanoparticles were used because of their small size, sustained release and positive charge which interact with the negatively charged surface of bacterial cell causing its destruction.

  • Ciprofloxacin paste and solutionDevice

    Conventional antibacterial paste and solution were compared to nanoparticles smart gels to treat endodontics bacterial infection

Study groups in NCT05475444
Study groupRoleWhat they receive
Paste and solution of ciprofloxacin as Conventional TreatmentExperimentalPaste and solution of ciprofloxacin as conventional dosage forms and drugs used to treat endodontics infections. For ciprofloxacin solution is used once daily while the paste form used weekly.
Receives: Device: Ciprofloxacin paste and solution
Chitosan coated PLGA nanoparticles entrapping ciprofloxacin and incorporated in smart poloxamer gelExperimentalChitosan coated PLGA nanoparticles entrapping ciprofloxacin and incorporated in smart poloxamer gel dosage forms treat endodontics infections
Receives: Device: Chitosan Coated PLGA nanoparticles entrapping Ciprofloxacin incorporated in smart gels

What is being measured

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

  1. Determination of Bacterial count by counting bacterial colonies of the sample

    Bacterial count was expected to be decreased by counting bacterial colonies of the sample after treatment and comparing with control without treatment

    Measured: One week

Secondary outcomes (1)
  1. Determination of the Biofilm inhibition using crystal violet and microplate reader

    Biofilm is to be inhibited and being small by using of stains crystal violet as marker, in order to more accurately identify cells of interest and distinguish from culture debris.

    Measured: one week

Timeline

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

  1. First posted27 Jul 2022
  2. Study start1 Mar 2020
  3. Primary completion8 Mar 2020
  4. Study completion15 Mar 2020

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
Model description
* Group I (negative control group): Root canals were not treated after cleaning and shaping. * Group II (positive control group): Root canals were treated with calcium hydroxide paste * Group III: Root canals were treated with CIP paste conventionally used by the dentist which was formed by mixing CIP with saline to form a paste. * Group IV: Root canals were treated with (F1) which is the prepared in-situ gel formulation containing CIP loaded chitosan coated PLGA nanoparticles. * Group V: Root canals were treated with (F2) which is the prepared in-situ gel containing ciprofloxacin hydrochloride.
Masking
None (open label)
Enrolment
55 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05475444
Sponsor's protocol ID
1643
Status last verified
Jul 2022
First submitted
6 Feb 2021
Last updated
27 Jul 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Chitosan Coated PLGA nanoparticles entrapping Ciprofloxacin incorporated in smart gels and Ciprofloxacin paste and solution in people with Bacterial Infections Oral, run by British University In Egypt 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 27 Jul 2022. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Determination of Bacterial count by counting bacterial colonies of the sample (time frame: One week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 27 Jul 2022.

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