| CTRI Number |
CTRI/2025/01/079558 [Registered on: 27/01/2025] Trial Registered Prospectively |
| Last Modified On: |
24/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Antimicrobial efficacy of Naturally derived alternatives as intracanal medicaments against Enterococcus faecalis: A Randomized Control Clinical Trial
|
|
Scientific Title of Study
|
Comparative evaluation of antimicrobial efficacy of chitosan, mangosteen and their combination as intracanal medicaments against E. faecalis: A Randomized Control Clinical Trial
|
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Lakshika Sharma |
| Designation |
MDS student |
| Affiliation |
Inderprastha Dental College and Hospital |
| Address |
Inderprastha Dental College and Hospital,Sahibabad Department of Conservative Dentistry And Endodontics ,FF-1 , 46/1, Sahibabad Industrial Area Site 4, Sahibabad, Ghaziabad, Uttar Pradesh
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 and Professor |
| Affiliation |
Inderprastha Dental College and Hospital |
| Address |
Inderprastha Dental College and Hospital,Sahibabad Department of Conservative Dentistry And Endodontics ,FF-1 , 46/1, Sahibabad Industrial Area Site 4, Sahibabad, Ghaziabad, Uttar Pradesh
Ghaziabad
UTTAR PRADESH
201010
India |
| Phone |
9354941405 |
| Fax |
|
| Email |
dvaghela52@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Lakshika Sharma |
| Designation |
MDS student |
| Affiliation |
Inderprastha Dental College and Hospital |
| Address |
Inderprastha Dental College and Hospital,Sahibabad Department of Conservative Dentistry And Endodontics ,FF-1 , 46/1, Sahibabad Industrial Area Site 4, Sahibabad, Ghaziabad, Uttar Pradesh
Ghaziabad
UTTAR PRADESH
201010
India |
| Phone |
9354941405 |
| Fax |
|
| Email |
lakshikasharma199@gmail.com |
|
|
Source of Monetary or Material Support
|
| Inderprastha Dental College and Hospital,Sahibabad Department of Conservative Dentistry And Endodontics ,FF-1 , 46/1, Sahibabad Industrial Area Site 4, Sahibabad, Ghaziabad, Uttar Pradesh |
|
|
Primary Sponsor
|
| Name |
Lakshika Sharma |
| Address |
Inderprastha Dental College and Hospital,Sahibabad Department of Conservative Dentistry And Endodontics ,FF-1 , 46/1, Sahibabad Industrial Area Site 4, Sahibabad, Ghaziabad, Uttar Pradesh, 201010 |
| 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 Lakshika Sharma |
Inderprastha Dental College & Hospital |
Inderprastha Dental College and Hospital,Sahibabad Department of Conservative Dentistry And Endodontics ,FF-1 , 46/1, Sahibabad Industrial Area Site 4, Sahibabad, Ghaziabad, Uttar Pradesh
Ghaziabad
UTTAR PRADESH |
9354941405
lakshikasharma199@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 |
non-vital tooth , single canal tooth.
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
chitosan |
Comparative evaluation of anti-microbial efficacy of chitosan as an intracanal medicament against E.faecalis for a period of seven days: an in vivo study |
| Intervention |
mangosteen |
Comparative evaluation of anti-microbial efficacy of mangosteen as an intracanal medicament against E.faecalis for a period of seven days: an in vivo study |
| Intervention |
mangosten combined with chitosan |
Comparative evaluation of anti-microbial efficacy of mangosteen combined with chitosan as an intracanal medicament against E.faecalis for a period of seven days: 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 |
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
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the antimicrobial efficacy of Mangosteen
To evaluate the antimicrobial efficacy of Chitosan
To evaluate the antimicrobial efficacy of mangosteen combined with chitosan |
For a period of seven days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the antimicrobial efficacy of Mangosteen, chitosan and their combination against Enterococcus faecalis |
for a period of seven days |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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)
|
15/02/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/02/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="15" |
|
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 - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
- 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 - Proposals should be directed to [lakshikasharma199@gmail.com].
- For how long will this data be available start date provided 11-07-2025 and end date provided 11-07-2050?
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 aim is to assess and compare the antimicrobial efficacy of mangosteen, chitosan and their combination as an intracanal medicament against E. faecalis |