| CTRI Number |
CTRI/2025/07/090602 [Registered on: 09/07/2025] Trial Registered Prospectively |
| Last Modified On: |
04/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Testing different medicaments to get rid off persistent bacteria in root canal
|
|
Scientific Title of Study
|
Comparative evaluation of intracanal medicaments for effective eradication of Enterococcus Faecalis, a persistent challenge- an in vivo 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 Nimisha Chaudhary |
| Designation |
Associate Professor |
| Affiliation |
Siddhpur Dental College and Hospital |
| Address |
14, Swagat Bungalow, Near Ramosana Circle, Mehsana
Department of Conservative and Endodontics, Siddhpur Dental College and Hospital Dethali Siddpur 384151
Patan
GUJARAT
384002
India |
| Phone |
9687627060 |
| Fax |
|
| Email |
drnimishachaudhary@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shikha Kanodia |
| Designation |
Professor |
| Affiliation |
Government Dental College and Hospital Ahmedabad |
| Address |
Kamalkumar,9,Sahajanand Villa-1, new CG road, Chandkheda, Gandhinagar, Gujarat 382424
Department of conservative dentistry and endodontics, govt dental college and hospital, civil hospital campus, Asarwa, Ahmedabad 380016
Ahmadabad
GUJARAT
382424
India |
| Phone |
9825465861 |
| Fax |
|
| Email |
shikhakk@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nimisha Chaudhary |
| Designation |
Associate Professor |
| Affiliation |
Siddhpur Dental College and Hospital |
| Address |
14, Swagat Bungalow, Near Ramosana Circle, Mehsana
Department of Conservative and Endodontics, Siddhpur Dental College and Hospital Dethali Siddpur 384151
Patan
GUJARAT
384002
India |
| Phone |
09687627060 |
| Fax |
|
| Email |
drnimishachaudhary@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of conservative dentistry and endodontics Siddhpur Dental College and Hospital Dethali Siddhapur 384151 |
|
|
Primary Sponsor
|
| Name |
Siddhpur Dental College and Hospital |
| Address |
Siddhpur Dental College and Hospital Dethali Siddhpur 384151 |
| Type of Sponsor |
Other [Siddhpur Dental College] |
|
|
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 Nimisha Chaudhary |
Siddhpur Dental College and Hospital |
Room No 4, Dept of conservative dentistry and endodontics, Siddhpur Dental College and Hospital, Dethali, Siddhpur
Patan
GUJARAT |
09687627060
drnimishachaudhary@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Govt Dental College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K049||Other and unspecified diseases ofpulp and periapical tissues, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Different intracanal medicaments |
post evaluation of E.faecalis count 7 days after placement of
1 triple antibiotic paste
2 bromelain extract paste
3 grape seed extract paste |
| Intervention |
ROOT CANAL TREATMENT |
COUNT OF COLONY FORMING UNIT FOR E.FEACALIS DURING DIFFERENT PHASE OF ROOT CANAL TREATMENT |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
-single rooted maxillary and mandibular anteriors and mandibular premolars
-teeth with caries and old restorations
-teeth having diagnosed with necrotic and infected pulp clinically
-radiographically periapical lesions with PAI Index score 1 to 3
-patients without any systemic diseases
|
|
| ExclusionCriteria |
| Details |
-patients with known medical history
-pregnant women
-cases requiring retreatment
-teeth with calcified canals, immature apex, sinus opening, external and internal resorption and teeth exhibiting grade III mobility
-periapical lesions with PAI index score 4 and 5 |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in Enterococcus Feacalis count after placement of intracanal medicaments |
-preevaluation of E.feacalis count 72 hous after access and shaping
-post evaluation of E.feacalis count after 1 week with all three intracanal medicaments |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
15/07/2025 |
| 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="5"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 - NO
|
|
Brief Summary
|
Comparative evaluation of intracanal medicaments for effective eradication of Enterococcus Faecalis a persistent challenge an in vivo study Aim Comparative evaluation of intracanal medicaments for effective eradication of Enterococcus Faecalis an in vivo study Objectives Pre evaluation of E. faecalis count from the root canal after access opening and immediately after instruments Post evaluation of E.faecalis counts obtained after 7 days placement of triple antibiotic paste Post evaluation of E.faecalis counts obtained after 7 days placement of Bromelain extract paste Post evaluation of E.faecalis counts obtained after 7 days placement of Grape seed extract paste to compare amongst them |