Efficacy of Herbal medication in the reduction of microbial load of the root canal
- Conditions
- Chronic apical periodontitis. Ayurveda Condition: DANTAGATAROGAH,
- Registration Number
- CTRI/2022/07/043862
- Lead Sponsor
- Dr Ram Surath Kumar K
- Brief Summary
**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. faecalis*count 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.aspera*and *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.aspera*and *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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 40
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- Patients with mature permanent maxillary central incisors, lateral incisors and canines with pulp necrosis, and asymptomatic apical periodontitis.
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- Patients above 18 years 3) Patients who are willing to give consent.
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- Patients with calcified pulp chamber, periapical cyst, and contributory medical history.
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- Patients with any other systemic/psychological conditions, history of allergy reactions to the herbal medicaments or chlorhexidine, under medications such as anti-inflammatory drugs, antibiotics, and steroids within the past 3 months.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1) Reduction of Enterococcus faecalis count Baseline, 7 days 2) Reduction of postoperative pain Baseline, 7 days
- Secondary Outcome Measures
Name Time Method Cost-effectiveness Baseline, 7 days
Trial Locations
- Locations (1)
KLE Vishwanath Katti Institute of Dental Sciences
🇮🇳Belgaum, KARNATAKA, India
KLE Vishwanath Katti Institute of Dental Sciences🇮🇳Belgaum, KARNATAKA, IndiaDr Ram Surath Kumar KPrincipal investigator9095066443ramsurathkumar1996@gmail.com