Comparative evaluation of antibacterial efficacy of combination of Achyranthes aspera Linn and Trachyspermum ammi Linn, calcium hydroxide, and chlorhexidine as intracanal medicaments: A double-blind randomized controlled trial

INTRODUCTION

Need for the study:

Elimination ofmicroorganisms from the root canal is the basis for successful endodontictreatment. Enteroccocus faecalis is a persistent organism that plays amajor 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 rootcanal as a single organism or as a major component of the root canal flora. In this study, the Herbal intracanal medicamentcontaining Achyranthes aspera L (root) and Trachyspermumammi L (Ajwain seeds)will be promoted as a natural alternative product that is relatively safe andinexpensive, suggesting its potential to be used as an endodontic intracanalmedicament.

Rationale of the currentstudy:

Calcium hydroxide hasbeen widely used as an intracanal medicament because of its bactericidalproperties. Its high pH of about 12.5 has a destructive effect on cellmembranes and protein structures. Chlorhexidine has also been the gold standardsince the 1940s because of its efficacy, substantivity, and antibacterialaction. However, chlorhexidine has several drawbacks. Researchers these dayshave been trying to pay more attention to herbal medications. This study aimsto evaluate and compare the antibacterial efficacy of combination of Achyranthes asperaLinn and Trachyspermum ammi *Linn,*calcium hydroxide, and chlorhexidineas intracanal medicaments.

OBJECTIVES

Primary

Todetermine and compare the antibacterial activity of A.aspera L and T.ammi L combinationbased intracanal medicamentwith 10% calcium hydroxide and 2% chlorhexidine gel against Enterococcusfaecalis.

Tocompare E. faecaliscount before and after intervention among A.aspera and T.ammi based intracanal medicament group, calciumhydroxide group, 2% chlorhexidine gel group, and placebo group in apatient undergoing primary endodontic therapy.

Secondary

To compare thecost-effectiveness and adverse effects of herbal intracanal medicament, chlorhexidine,and calcium hydroxide.

RESEARCH HYPOTHESIS

There is a difference inthe effectiveness in thereduction of microbial count in patient undergoing primary endodontic therapybetween A.aspera and T.ammi based intracanal medicamentgroup, calcium hydroxide group, 2% chlorhexidine gel group, and placebo group.

METHODOLOGY

IN-VITRO STUDY

T.ammi and A.aspera plants will beauthenticated by the taxonomist in ICMR-NITM, Belagavi.

T.ammi L (Ajwain seeds) and A.asperaL (roots) will be procured and will be made into coarse powder in KLEAyurveda pharmacy, Belagavi.

The followingprocedures will be carried out using a standard protocol**:**

Extract preparation will be done in ICMR-NITM, Belagavi.

The phytochemicalscreening will be performedin KLE Ayurveda college Research Laboratory.

Solubility test, Determination of MIC and MBC for extracts,chlorhexidine solution (2%)and 10% Calcium Hydroxide inBSRC.

Intracanal medicament preparationunder the guidance of the faculty of KLE Pharmacy college.

MICand Zone of Inhibition for A.aspera & T.ammi based Intracanal medicament,10% CalciumHydroxide, and 2% chlorhexidine gel in BSRC.

Cytotoxicity analysis will be done ongingival fibroblasts by the MTT Assayin BSRC.

B)  IN-VIVO STUDY

Study design; Double-blind, randomized,parallel-group, placebo-controlled clinical trial

Study setting

Department of PublicHealth Dentistry, KAHER’s KLE VK Institute of Dental Sciences.

Subject Selection:

Fourty adult patientsundergoing primary endodontic therapy at Department of Public Health Dentistry,KAHER’s KLE VK Institute of Dental Sciences, Belagavi, Karnataka.

**Sampling technique:**A simplerandom sampling technique.

Procedure for measurements including the process forstandardization:

Under aseptic conditions,root canal culture sample will be taken with sterile paper points. Standardprotocol will be adapted during the collection of samples.

Informed consent and assent:

Written consent will beobtained from study participants participating in the study before theexamination. Participants who agree to give consent will be included

STATISTICALANALYSIS:

Data obtained will be entered into an excel sheet and statisticalanalysis 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 outto determine the difference between and within the groups.

Paired t test / Wilcoxon signed-ranktest will be carried out to determine the differences at baseline and at7th day in different intracanal medicament groups (intragroupcomparison) using SPSS v.21,will be used with a level of significance of 5% (p<0.05)

IMPLICATIONS

Ifthe results of this study depict A.asperaand T.ammi based intracanalmedicament to be comparable with calcium hydroxide and chlorhexidine, it can beused as a novel alternative antimicrobial agent that is more cost-effective andefficient. It may beused as an alternative endodontic intracanal medicament. Otherdesirable therapeutic properties of A.asperaand T.ammi are antifungal,antioxidant, anti-inflammatory properties give it an  added advantage (5)(11).

Production of new herbalintracanal medicaments containing Achyranthesaspera and Trachyspermum ammi canbe used in pharmaceutical industries as an antibacterial agent, as it isrelatively safe and inexpensive. There has been a remarkable risein the use of medicinal plant products in recent years, because of it beingnon-chemical and non-synthetic. The quest of mankind for the introduction ofnewer materials to overcome the side effects of chemical agents never ends. Itis the need of the hour to bring newer cost-effective, natural, andbiocompatible antibacterial agents to the forefront.