Antimicrobial Effect of Modified Antibiotic Nanofibers for Regenerative Endodontics Procedures

September 28, 2018 updated by: sara Gamal Ahmed, Cairo University

Evaluation of the Antimicrobial Effect of Pre-synthesized Novel Antibiotic Electrospun Nanofibers as an Intracanal Delivery Strategy for Regenerative Endodontics A Randomized Clinical Trial

The treatment for immature teeth with pulp necrosis can be carried out through apexification or regenerative endodontics procedures including platelet rich plasma (PRP), platelet rich fibrin (PRF) and injectable PRF, these techniques used alone or in combination. Revascularization therapy carries on more advantages than apexification, such as inducing root-end development and reinforcement. However, apical repair will not happen in the presence of inflamed and infected tissue.the aim of this study is to evaluate the antimicrobial effect of pre-synthesized novel antibiotic loaded electrospun nanofibers used in patients with immature necrotic teeth.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Title: Evaluation of the Antimicrobial Effect of Pre-synthesized Novel Antibiotic Electrospun Nanofibers as an Intracanal Delivery Strategy for Regenerative Endodontics - A Randomized Clinical Trial

Rationale Regenerative endodontics technique outcome depends on microbial elimination because apical repair will not happen in the presence of infected tissues. It is well established that bacteria are essential for the development of pulpal and periapical pathosis. Eradication or control of bacteria may provide optimal treatment outcome. However, elimination of bacteria from infected root canal systems is challenging. Numerous measures have been described to reduce the number of bacteria in the root canal system, including the use of various instrumentation techniques, irrigation regimens and intra-canal medicaments. There is no definitive evidence in the literature that all these measures result in a bacteria-free root canal system.

Therefore additional methods such as the use of intra-canal medicaments are required in order to maximize disinfection of root canal system and kill as many bacteria as possible. Antibiotics have been proposed as intracanal medicament but any single antibiotic is unlikely effective to sterilize diverse flora in root canal infection.

Recently, triple antibiotic mixture (TAP) has been reported for successful disinfection of infected root dentine. This mixture consist of ciprofloxacin (CIP), metronidazole (MET) and minocycline (MINO) which consistently sterilize bacteria of infected dentine and infected pulps . Specifically, MET is a bactericidal imidazole that is highly effective against obligate anaerobic bacteria, CIP is a bactericidal broad-spectrum synthetic quinolone and MINO is a bacteriostatic broad-spectrum tetracycline.

However, as minocycline binds to dentin and causes tooth discoloration, it is recommended to remove minocycline from TAP and use only MET and CIP, or to use modified TAPs containing cefaclor or clindamycin (CLIN). CLIN is a bacteriostatic lincosamide known for its efficacy against a broad spectrum of endodontic bacteria.

In recent years, an innovative strategy has been considered to develop a low-concentration, yet antimicrobially effective and biocompatible polymer-based nanofibrous electrospun scaffolds as a drug delivery system to promote intracanal biofilm eradication . Electrospinning has been considered as a highly effective process to obtain extracellular matrix (ECM) mimicking structures with adequate chemistry and three-dimensional porous architectures Moreover, it has enabled the synthesis of bioactive nanofibrous scaffolds The electrospinning technology has attracted great interest in recent decades, thanks to its capability of easily and effectively processing a huge range of polymeric materials in form of nanofibers. In recent years, the health concerns associated with the systemic side effects of synthetic compounds used in medicine and the emergence of antibiotic resistance of pathogens have driven electrospinning research towards the development of antibiotic loaded nanofibers.

Hypothesis To test the null hypothesis, which is in patients with necrotic immature teeth, will the use of pre-synthesized clindamycin modified triple antibiotic electrospun nanofibers have more profound antimicrobial effect than modified triple antibiotic paste.

Objectives of the present study

  • Primary objective To compare the antimicrobial effect of pre-synthesized novel antibiotic loaded nanofibers used in patients with immature necrotic teeth with modified triple antibiotic paste.
  • Secondary objective To evaluate the morphology of pre-synthesized antibiotic loaded electrospun nanofibers.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

3 years to 21 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Maxillary or mandibular single-root tooth with:

  • Non-vital response of pulp tissue.
  • Immature root.
  • Asymptomatic patients.

Exclusion Criteria:

  1. Patients allergic to metronidazole, ciprofloxacin, or clindamycin to avoid allergic reaction in the intervention group.
  2. Patients who received antibiotics in the past 3 months.
  3. Vital cases or previously accessed teeth.
  4. Teeth with unfavorable conditions for rubber-dam application.
  5. Patients with systemic and immune-compromising disease as they have impaired healing

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: electrospun TAP nanofibers
Revascularization procedure with Electrospun TAP nanofibers as as an intracanal medicament for immature necrotic teeth
Procedure: electrospun TAP nanofibers
electrospun TAP loaded nanofibers containing modified triple antibiotic paste of clindamycin , ciprofloxacin and metronidazole by electrospinning process will be placed in the root canals. The access cavity will be sealed with temporary filling material
Active Comparator: modified TAP paste
Revascularization procedure with modified TAP paste as an intracanal medicament for immature necrotic teeth
Procedure: modified TAP paste
modified TAP paste will be prepared by mixing equal proportions of CIP, MET and CLIN then placed inside the root canal, access cavity will be sealed with temporary filling

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
antimicrobial effect
Time Frame: 2-3 weeks
number of colony forming units of bacteria after using the intracanal medicaments
2-3 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
morphology of nanofibers
Time Frame: 1 week
surface morphology will be studied under the scanning electron microscope
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 28, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 28, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 1, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 1, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 28, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Cairo University dentistry

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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