| CTRI Number |
CTRI/2021/08/035766 [Registered on: 18/08/2021] Trial Registered Prospectively |
| Last Modified On: |
21/08/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
compare Antimicrobial efficacy of Homeopathic medicines with Ayurvedic and Allopathic medicine against E. faecalis when used as intracanal medicament |
|
Scientific Title of Study
|
Antimicrobial efficacy of Homeopathic medicines with Ayurvedic and Allopathic medicine against E. faecalis when used as intracanal medicament – An In-vivo and Ex-vivo Comparison |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Hitesh Gupta |
| Designation |
professor |
| Affiliation |
Himachal Institute of dental sciences |
| Address |
Room no. 9, Department of Conservative Dentistry and Endodontics, Himachal Institute of dental Sciences, paonta sahib
Room no. 9, deprtment of Conservative Dentistry and endodontics, himachal institute of dental sciences
Sirmaur
HIMACHAL PRADESH
173025
India |
| Phone |
9997034993 |
| Fax |
|
| Email |
dent.hitesh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manpreet Arora |
| Designation |
Professor |
| Affiliation |
SGT UNIVERSITY |
| Address |
Department Of Oral Pathology and Microbiology
Faculty of Dental Sciences
SGT University
Budhera, Gurgaon, Haryana
Dept no 9
Third floor B Block
Sgt dental college
SGT UNIVERSITY
Budhera Gurgaon 122505
Gurgaon
HARYANA
122505
India |
| Phone |
9871173531 |
| Fax |
|
| Email |
aroramanpreet2005@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manpreet Arora |
| Designation |
Professor |
| Affiliation |
SGT UNIVERSITY |
| Address |
Department Of Oral Pathology and Microbiology
Faculty of Dental Sciences
SGT University
Budhera, Gurgaon, Haryana
Dept no 9
Third floor B Block
Sgt dental college
SGT UNIVERSITY
Budhera Gurgaon 122505
Gurgaon
HARYANA
122505
India |
| Phone |
9871173531 |
| Fax |
|
| Email |
aroramanpreet2005@gmail.com |
|
|
Source of Monetary or Material Support
|
| Himachal Institute of Dental Sciences, Paonta Sahib, HP |
|
|
Primary Sponsor
|
| Name |
SGT Dental college |
| Address |
SGT University, bhudhera, Gurugram -122505, Haryana |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Abhiney Puri |
Himachal Institute of Dental Sciences |
Deprtment of Conservative Dentistry and endodontics, room no. 9,HIMACHAL INSTITUTE OF DENTAL SCIENCES, paonta sahib 173025, H.P
Sirmaur
HIMACHAL PRADESH |
9837633549
abhiney72@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SGT University Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K041||Necrosis of pulp, (2) ICD-10 Condition: R52||Pain, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
antimicrobial activity |
0.9%w/v Sodium Chloride to be used as control |
| Comparator Agent |
Antimicrobial Activity |
2% chlorhexidine Digluconate, Propolis , Rhus Glabra 200 CH and Zincum Oxidatum 200 CH, would used in experimental groups for antimicrobial activity to be checked after 7 days |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Enough crown structure for adequate isolation,
2.No response to pulp sensibility test, radiographic appearance of periapical radiolucency
3.No history of previous endodontic treatment in the involved tooth |
|
| ExclusionCriteria |
| Details |
1. Teeth from patients who receive endodontic therapy
2. Teeth with gross carious lesions
3.teeth with root or crown fracture
4.patients with marginal periodontitis exhibiting pocket depth deeper than 4mm |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| antimicrobial Activity |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pain, swelling |
1 week |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
20/08/2021 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
to be publish after completion |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
for the Ex Vivo antimicrobial activity of the experimental groups E. Faecalis was grown onto the tooth to form biofilm using BHI broth with the medicament placed in it. The antimicrobial activity was calculated after 7 days using rtPCR technique. for the in vivo study the patient were selected based on inclusion criteria. The Access opening were done and a pre operative sample from the root canal would be taken using paper point. after the completion of cleaning and shaping respective antimicrobial agent would be placed inside the canal as intra canal medicament and the close would be temporarily closed . after a span of 7 days patient would be recalled and second sample would be collected from the canal to check for the antimicrobial activity using rtPCR |