Antimicrobial Effect of Modified Antibiotic Nanofibers for Regenerative Endodontics Procedures
Primary Purpose
Necrosis, Pulp
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
electrospun TAP nanofibers
modified TAP paste
Sponsored by
About this trial
This is an interventional treatment trial for Necrosis, Pulp focused on measuring immature teeth
Eligibility Criteria
Inclusion Criteria:
Maxillary or mandibular single-root tooth with:
- Non-vital response of pulp tissue.
- Immature root.
- Asymptomatic patients.
Exclusion Criteria:
- Patients allergic to metronidazole, ciprofloxacin, or clindamycin to avoid allergic reaction in the intervention group.
- Patients who received antibiotics in the past 3 months.
- Vital cases or previously accessed teeth.
- Teeth with unfavorable conditions for rubber-dam application.
- Patients with systemic and immune-compromising disease as they have impaired healing
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
electrospun TAP nanofibers
modified TAP paste
Arm Description
Revascularization procedure with Electrospun TAP nanofibers as as an intracanal medicament for immature necrotic teeth
Revascularization procedure with modified TAP paste as an intracanal medicament for immature necrotic teeth
Outcomes
Primary Outcome Measures
antimicrobial effect
number of colony forming units of bacteria after using the intracanal medicaments
Secondary Outcome Measures
morphology of nanofibers
surface morphology will be studied under the scanning electron microscope
Full Information
NCT ID
NCT03690960
First Posted
September 28, 2018
Last Updated
September 28, 2018
Sponsor
Cairo University
1. Study Identification
Unique Protocol Identification Number
NCT03690960
Brief Title
Antimicrobial Effect of Modified Antibiotic Nanofibers for Regenerative Endodontics Procedures
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Unknown status
Study Start Date
December 2018 (Anticipated)
Primary Completion Date
August 2020 (Anticipated)
Study Completion Date
October 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
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
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Necrosis, Pulp
Keywords
immature teeth
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
electrospun TAP nanofibers
Arm Type
Experimental
Arm Description
Revascularization procedure with Electrospun TAP nanofibers as as an intracanal medicament for immature necrotic teeth
Arm Title
modified TAP paste
Arm Type
Active Comparator
Arm Description
Revascularization procedure with modified TAP paste as an intracanal medicament for immature necrotic teeth
Intervention Type
Procedure
Intervention Name(s)
electrospun TAP nanofibers
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
modified TAP paste
Intervention Description
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
Primary Outcome Measure Information:
Title
antimicrobial effect
Description
number of colony forming units of bacteria after using the intracanal medicaments
Time Frame
2-3 weeks
Secondary Outcome Measure Information:
Title
morphology of nanofibers
Description
surface morphology will be studied under the scanning electron microscope
Time Frame
1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Maxillary or mandibular single-root tooth with:
Non-vital response of pulp tissue.
Immature root.
Asymptomatic patients.
Exclusion Criteria:
Patients allergic to metronidazole, ciprofloxacin, or clindamycin to avoid allergic reaction in the intervention group.
Patients who received antibiotics in the past 3 months.
Vital cases or previously accessed teeth.
Teeth with unfavorable conditions for rubber-dam application.
Patients with systemic and immune-compromising disease as they have impaired healing
12. IPD Sharing Statement
Learn more about this trial
Antimicrobial Effect of Modified Antibiotic Nanofibers for Regenerative Endodontics Procedures
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