INTRODUCTION
Need for the study:
Elimination of
microorganisms from the root canal is the basis for successful endodontic
treatment. Enteroccocus faecalis is a persistent organism that plays a
major role in the etiology of periradicular lesions after root canal treatment.
It is found in 22–77% of endodontic failure cases and can survive in the root
canal as a single organism or as a major component of the root canal flora. In this study, the Herbal intracanal medicament
containing Achyranthes aspera L (root) and Trachyspermum
ammi L (Ajwain seeds) will be promoted as a natural alternative product that is relatively safe and
inexpensive, suggesting its potential to be used as an endodontic intracanal
medicament.
Rationale of the current
study:
Calcium hydroxide has
been widely used as an intracanal medicament because of its bactericidal
properties. Its high pH of about 12.5 has a destructive effect on cell
membranes and protein structures. Chlorhexidine has also been the gold standard
since the 1940s because of its efficacy, substantivity, and antibacterial
action. However, chlorhexidine has several drawbacks. Researchers these days
have been trying to pay more attention to herbal medications. This study aims
to evaluate and compare the antibacterial efficacy of combination of Achyranthes aspera
Linn and Trachyspermum ammi Linn,
calcium hydroxide, and chlorhexidine as intracanal medicaments.
OBJECTIVES
Primary
To
determine and compare the antibacterial activity of A.aspera L and T.ammi L combination based intracanal medicament
with 10% calcium hydroxide and 2% chlorhexidine gel against Enterococcus
faecalis.
To
compare E. faecalis count before and after intervention among A.aspera and T.ammi based intracanal medicament group, calcium
hydroxide group, 2% chlorhexidine gel group, and placebo group in a
patient undergoing primary endodontic therapy.
Secondary
To compare the
cost-effectiveness and adverse effects of herbal intracanal medicament, chlorhexidine, and calcium hydroxide.
RESEARCH HYPOTHESIS
There is a difference in
the effectiveness in the
reduction of microbial count in patient undergoing primary endodontic therapy
between A.aspera and T.ammi based intracanal medicament group, calcium hydroxide group, 2% chlorhexidine gel group, and placebo group.
METHODOLOGY
IN-VITRO STUDY
T.ammi and A.aspera plants will be
authenticated by the taxonomist in ICMR-NITM, Belagavi.
T.ammi L (Ajwain seeds) and A.aspera
L (roots) will be procured and will be made into coarse powder in KLE
Ayurveda pharmacy, Belagavi.
The following
procedures will be carried out using a standard protocol:
Extract preparation will be done in ICMR-NITM, Belagavi.
The phytochemical
screening will be performed in KLE Ayurveda college Research Laboratory.
Solubility test, Determination of MIC and MBC for extracts,
chlorhexidine solution (2%)
and 10% Calcium Hydroxide in
BSRC.
Intracanal medicament preparation
under the guidance of the faculty of KLE Pharmacy college.
MIC
and Zone of Inhibition for A.aspera & T.ammi based Intracanal medicament,10% Calcium
Hydroxide, and 2% chlorhexidine gel in BSRC.
Cytotoxicity analysis will be done on
gingival fibroblasts by the MTT Assay
in BSRC.
B) IN-VIVO STUDY
Study design; Double-blind, randomized,
parallel-group, placebo-controlled clinical trial
Study setting
Department of Public
Health Dentistry, KAHER’s KLE VK Institute of Dental Sciences.
Subject Selection:
Fourty adult patients
undergoing primary endodontic therapy at Department of Public Health Dentistry,
KAHER’s KLE VK Institute of Dental Sciences, Belagavi, Karnataka.
Sampling technique:
A simple
random sampling technique.
Procedure for measurements including the process for
standardization:
Under aseptic conditions,
root canal culture sample will be taken with sterile paper points. Standard
protocol will be adapted during the collection of samples.
Informed consent and assent:
Written consent will be
obtained from study participants participating in the study before the
examination. Participants who agree to give consent will be included
STATISTICAL
ANALYSIS:
Data obtained will be entered into an excel sheet and statistical
analysis will be done.
Descriptive Statistics will be calculated.
One-way ANOVA / Kruskal Wallis followed by Tukey’s / Dunn’s post hoc test will be carried out
to determine the difference between and within the groups.
Paired t test / Wilcoxon signed-rank
test will be carried out to determine the differences at baseline and at
7th day in different intracanal medicament groups (intragroup
comparison) using SPSS v.21,
will be used with a level of significance of 5% (p<0.05)
IMPLICATIONS
If
the results of this study depict A.aspera
and T.ammi based intracanal
medicament to be comparable with calcium hydroxide and chlorhexidine, it can be
used as a novel alternative antimicrobial agent that is more cost-effective and
efficient. It may be
used as an alternative endodontic intracanal medicament. Other
desirable therapeutic properties of A.aspera
and T.ammi are antifungal,
antioxidant, anti-inflammatory properties give it an added advantage (5)(11).
Production of new herbal
intracanal medicaments containing Achyranthes
aspera and Trachyspermum ammi can
be used in pharmaceutical industries as an antibacterial agent, as it is
relatively safe and inexpensive. There has been a remarkable rise
in the use of medicinal plant products in recent years, because of it being
non-chemical and non-synthetic. The quest of mankind for the introduction of
newer materials to overcome the side effects of chemical agents never ends. It
is the need of the hour to bring newer cost-effective, natural, and
biocompatible antibacterial agents to the forefront.
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