| CTRI Number |
CTRI/2022/09/045532 [Registered on: 15/09/2022] Trial Registered Prospectively |
| Last Modified On: |
07/01/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Herbal intracanal medicaments in dentistry |
|
Scientific Title of Study
|
Comparative evaluation of antimicrobial efficacy of 2% Chlorhexidine gel, Triphala and A.indica as an intracanal medicament against E.faecalis: An in vivo study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kunal Bedi |
| Designation |
MDS 3rd year student |
| Affiliation |
Inderprastha Dental College And Hospital, Sahibabad, Ghaziabad |
| Address |
Inderprastha Dental College And Hospital, Sahibabad, Ghaziabad
Ghaziabad
UTTAR PRADESH
201010
India |
| Phone |
9560613130 |
| Fax |
|
| Email |
bedikunal55@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr DAKSHITA JOY SINHA |
| Designation |
PROFESSOR AND HOD |
| Affiliation |
Inderprastha Dental College And Hospital, Sahibabad, Ghaziabad |
| Address |
Inderprastha Dental College And Hospital, Sahibabad, Ghaziabad
Ghaziabad
UTTAR PRADESH
201010
India |
| Phone |
9760340728 |
| Fax |
|
| Email |
dvaghela52@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kunal Bedi |
| Designation |
MDS 3rd year student |
| Affiliation |
Inderprastha Dental College And Hospital, Sahibabad, Ghaziabad |
| Address |
Inderprastha Dental College And Hospital, Sahibabad, Ghaziabad
Ghaziabad
UTTAR PRADESH
201010
India |
| Phone |
9560613130 |
| Fax |
|
| Email |
bedikunal55@gmail.com |
|
|
Source of Monetary or Material Support
|
| Inderprastha Dental College And Hospital, Sahibabad, Ghaziabad |
|
|
Primary Sponsor
|
| Name |
Dr Kunal Bedi |
| Address |
Inderprastha Dental College And Hospital, Sahibabad, Ghaziabad |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Kunal bedi |
Inderprastha Dental College and Hospital, Sahibabad, GHaziabad |
room no. FF-1, Department of Conservative Dentistry and Endodontics
Ghaziabad
UTTAR PRADESH |
9560613130
bedikunal55@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Inderprastha Dental College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K041||Necrosis of pulp, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
A.indica |
0.5mg inside the root canal as medicament for 7 days |
| Comparator Agent |
Chlorhexidine 2% gel |
2% Chlohexidine gel inside the root canal as medicament for 7 days |
| Comparator Agent |
normal saline |
no intracanl medicament will be placed |
| Intervention |
Triphala Powder |
0.5mg inside the root canal as medicament for 7 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
patient with non-vital teeth, single canal and single rooted teeth |
|
| ExclusionCriteria |
| Details |
mandibular incisors, curved canals or roots |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| decrease in E.faecalis count |
7 DAYS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| colony forming unit of E.faecalis |
7 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/09/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
none |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Complete debridement and effective disinfection of the root canal space is an important step for achieving long term success of nonsurgical endodontics and this is achieved by effective chemomechanical preparation.
Proper chemomechanical preparation reduces a large number of microorganisms in the canals. However, the microorganisms can still remain viable after root canal preparation and gets multiplied between the treatment because of presence of anatomical complexities like dentinal tubules, ramifications, isthmuses and apical deltas and the limitation in accessing the canal system by instrumentation and irrigation. So, use of an intracanal medicament helps in the elimination of microorganisms that remains even after cleaning and shaping.
Chlorhexidine (CHX) is a bis-biguanide that has a broad-spectrum antimicrobial activity and is active against both gram positive and gram-negative microbes. 2% CHX has been used as an intracanal medicament and had shown potent results in the past against common endodontic pathogens especially E.faecalis.
But in this modern era of dentistry more attention is towards the safer option of herbal alternatives like A.indica (Neem) and Triphala which have been used since many years in the field of ayurvedic medicine due to their anti-microbial, anti-inflammatory, anti-oxidant, anti-tumour, and many other properties.
Triphala is a traditional ayurvedic herbal formulation consisting of the dried fruits of three medicinal plants Terminalia chebula (Haritaki), Terminalia bellerica (Bibhitaki) and Phyllanthus emblica (Amla). Triphala means ’three’ [tri] ’fruits’ [phala]. It has a potential of anti-bacterial and anti-inflammatory activity.
Neem is known to have medicinal property by each part of the tree. It has anti viral, anti fungal, anti bacterial and anti carcinogenic activity. Nimbidin is a major active component isolated from seed of A.indica which is responsible for its biological activities. The antimicrobial effects of Neem have been reported against S. mutans, E. faecalis and C. albicans.
Yet very few studies have been conducted in patients using herbal products as an intracanal medicament. So, there is a need of constant research required to find safer herbal alternative as an intra-canal medicament.
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