| CTRI Number |
CTRI/2024/03/063499 [Registered on: 04/03/2024] Trial Registered Prospectively |
| Last Modified On: |
02/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Evaluation for best herbal medicine to be placed inside the root canal during endodontic therapy |
|
Scientific Title of Study
|
Comparative evaluation of anti-microbial efficacy of 2% Chlorhexidine gel, Triphala and A.indica as an intracanal medicament against E.faecalis : an invivo study |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Lakshika Sharma |
| Designation |
MDS student |
| Affiliation |
Inderprastha Dental College and Hospital,Sahibabad |
| Address |
Department of Conservative Dentistry And Endodontics ,FF-1 ,Inderprastha Dental College and Hospital, 46/1, Sahibabad Industrial Area Site 4, Sahibabad, Ghaziabad, Uttar Pradesh 201010
Ghaziabad
Department of Conservative Dentistry And Endodontics ,FF-1 ,Inderprastha Dental College and Hospital, 46/1, Sahibabad Industrial Area Site 4, Sahibabad, Ghaziabad, Uttar Pradesh 201010
Ghaziabad
Ghaziabad
UTTAR PRADESH
201010
India |
| Phone |
9354941405 |
| Fax |
|
| Email |
lakshikasharma199@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dakshita Joy Sinha |
| Designation |
Head of Department |
| Affiliation |
Inderprastha Dental College and Hospital,Sahibabad |
| Address |
Department of Conservative Dentistry And Endodontics ,FF-1 ,Inderprastha Dental College and Hospital, 46/1, Sahibabad Industrial Area Site 4, Sahibabad, Ghaziabad, Uttar Pradesh 201010
Ghaziabad
Ghaziabad
UTTAR PRADESH
201010
India |
| Phone |
|
| Fax |
|
| Email |
dvaghela52@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Lakshika Sharma |
| Designation |
MDS student |
| Affiliation |
Inderprastha Dental College and Hospital,Sahibabad |
| Address |
Department of Conservative Dentistry And Endodontics ,FF-1 ,Inderprastha Dental College and Hospital, 46/1, Sahibabad Industrial Area Site 4, Sahibabad, Ghaziabad, Uttar Pradesh 201010
Ghaziabad
Ghaziabad
UTTAR PRADESH
201010
India |
| Phone |
9354941405 |
| Fax |
|
| Email |
lakshikasharma199@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Conservative Dentistry And Endodontics ,FF-1 ,Inderprastha Dental College and Hospital, 46/1, Sahibabad Industrial Area Site 4, Sahibabad, Ghaziabad, Uttar Pradesh 201010
Ghaziabad
|
|
|
Primary Sponsor
|
| Name |
Lakshika Sharma |
| Address |
Department of Conservative Dentistry And Endodontics ,FF-1 ,Inderprastha Dental College and Hospital, 46/1, Sahibabad Industrial Area Site 4, Sahibabad, Ghaziabad, Uttar Pradesh 201010
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 Dakshita Joy Sinha |
Inderprastha Dental College & Hospital |
Department of Conservative Dentistry And Endodontics ,FF-1 ,Inderprastha Dental College and Hospital, 46/1, Sahibabad Industrial Area Site 4, Sahibabad, Ghaziabad, Uttar Pradesh 201010
Ghaziabad
Ghaziabad
UTTAR PRADESH |
9354941405
dvaghela52@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical committee of Inderprastha Dental College & Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Single rooted non vitalteeth with single root canal,Teeth requiring root canal treatment; symptomatic teeth without perapical lesion , calcifications and resorption
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
2% chlorhexidine gel, Triphala and Azadirachta indica
|
Comparative evaluation of anti-microbial efficacy of 2% chlorhexidine gel, Triphala and Azadirachta indica as an intracanal medicament against E.faecalis for a period of seven days: an in vivo study
|
| Intervention |
Calcium hydroxide |
Comparative evaluation of anti-microbial efficacy of 2% chlorhexidine gel, Triphala and Azadirachta indica as an intracanal medicament against E.faecalis : an in vivo study |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1.Single rooted teeth with single canal
2. Non-vital teeth
3. Sufficient crown structure for adequate isolation
4. Age of patients between 18-55 years
|
|
| ExclusionCriteria |
| Details |
1. Teeth with external/internal resorption
2. Calcified and curved canal
3. Teeth with immature apex
4. Pregnant women
5. Patients who do not consent to participate in study
•Periapical radiolucency >5mm
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
•To evaluate the antimicrobial efficacy of Calcium hydroxide.
•To evaluate the antimicrobial efficacy of 2% Chlorhexidine gel.
•To evaluate the antimicrobial efficacy of Triphala.
•To evaluate the antimicrobial efficacy of Azadirachta indica.
|
for a period of seven days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparative evaluation of the antimicrobial efficacy of Calcium hydroxide, triphala, Azadirachta indica & 2% chlorhexidine. |
for a period of seven 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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
11/03/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
11/03/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="10" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response (Others) -
- For how long will this data be available start date provided 29-02-2024 and end date provided 28-02-2025?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
The study’s objective is to assess and compare the antimicrobial effectiveness of 2% Chlorhexidine, Triphala and Azadirachta indica as an intracanal medicament against E.faecalis |