Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT03690960 |
| Other study ID # |
Cairo University dentistry |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 2018 |
| Est. completion date |
October 2020 |
Study information
| Verified date |
September 2018 |
| Source |
Cairo University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
