| CTRI Number |
CTRI/2025/12/099164 [Registered on: 16/12/2025] Trial Registered Prospectively |
| Last Modified On: |
16/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Probiotic
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of antimicrobial efficacy of different intracanal medicaments used against E. Faecalis among permanent anterior tooth |
|
Scientific Title of Study
|
Comparative Evaluation of Antimicrobial
Efficacy of Bioceramic-Based Intracanal
Medicament, Calcium Hydroxide with
Iodoform Paste, and Probiotic Paste with
Saline Against E. faecalis in Permanent
Anterior Teeth: A Randomized Controlled
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 |
DR JYOTSNA CHHABRA |
| Designation |
MDS STUDENT |
| Affiliation |
Sudha Rustagi College of Dental Sciences and Research |
| Address |
Room number 6 Department of Pedodontics Sudha Rustagi College of Dental Sciences and Research
Faridabad
HARYANA
121002
India |
| Phone |
08810600491 |
| Fax |
|
| Email |
jyotsnachhabra1422@gamil.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR NEHA SHEORAN |
| Designation |
PROFESSOR |
| Affiliation |
Sudha Rustagi College of Dental Sciences and Research |
| Address |
Room number 6 Department of Pedodontics Sudha Rustagi College of Dental Sciences and Research
Faridabad
HARYANA
121002
India |
| Phone |
09711544829 |
| Fax |
|
| Email |
sheoran.neha@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
DR NEHA SHEORAN |
| Designation |
PROFESSOR |
| Affiliation |
Sudha Rustagi College of Dental Sciences and Research |
| Address |
Room number 6 Department of Pedodontics Sudha Rustagi College of Dental Sciences and Research
Faridabad
HARYANA
121002
India |
| Phone |
09711544829 |
| Fax |
|
| Email |
sheoran.neha@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Sudha Rustagi College of Dental Sciences and Research, Faridabad, Haryana, 121002 |
|
|
Primary Sponsor
|
| Name |
DR JYOTSNA |
| Address |
RPS PALM DRIVE building no 113 first floor sector 88 faridabad haryana 121002 |
| 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 JYOTSNA CHHABRA |
Sudha Rustagi College of Dental Sciences and Research |
Room number 6, Department of Pedodontics Sudha Rustagi College
of Dental Sciences
and Research sector 88
Faridabad
HARYANA
Faridabad
HARYANA |
08810600491
jyotsnachhabra1422@gamil.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRCDSR Institutional ethical comitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
permanent anterior teeth indicated for Root canal treatment |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bioceramic based Intracanal
Medicament |
A new material as intracanal medicament, Post-BMP, a second sample will be taken and the intracanal medicament will be placed in the canal for 7 days. After 7 days, the medicament will be removed and a sample will be collected. |
| Comparator Agent |
CALCIUM HYDROXIDE WITH IODOFORM PASTE |
Gold standard Post-BMP, a second sample will be taken and the intracanal medicament will be placed in the canal for 7 days. After 7 days, the medicament will be removed and a sample will be collected. |
| Comparator Agent |
PROBIOTIC PASTE WITH SALINE |
Probiotic paste with saline is a effective intracanal medicament by supporting beneficial microflora and reducing pathogenic bacteria.Post-BMP, a second sample will be taken and the intracanal medicament will be placed in the canal for 7 days. After 7 days, the medicament will be removed and a sample will be collected. |
|
|
Inclusion Criteria
|
| Age From |
9.00 Year(s) |
| Age To |
13.00 Year(s) |
| Gender |
Both |
| Details |
Subjects who give verbal assent and whose parents will give the informed
consent.
Anterior permanent teeth with traumatic or carious lesions with exposure of
pulp.
Teeth with minimal periapical changes with sufficient bone support.
Teeth that can be restored.
Subjects who had not taken any antibiotics since 3 months preceding the
treatment will be incorporated in the study. |
|
| ExclusionCriteria |
| Details |
Presence of signs such as prolonged or spontaneous pain, pathological mobility (Miller’s Grade II or more), sensitivity to percussion.
The medically compromised patients and patients who had taken antibiotics
within three months or require antibiotic during treatment.
Non restorable tooth / Perforation of pulpal floor.
Radiographic signs of internal/external root resorption.
Previously endodontically treated teeth.
Uncooperative children |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Difference in Microbial Count of E.Faecalis
after access opening and after BMP |
Difference in microbial count of E. faecalis after access opening and after biomechanical preparation (BMP). The first sample will be collected immediately after access opening, and the second sample will be collected on the same day following completion of BMP. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Decrease in E.
Faecalis Count |
Decrease in E. faecalis Count After 1-Week Placement of Intracanal Medicaments Bioceramic-Based Intracanal Medicament, Calcium Hydroxide with Iodoform Paste & Probiotic Paste with Saline. Post-BMP, the intracanal medicament will be placed in the root canal & maintained for a period of 7 days. After 7 days, the intracanal medicament will be removed & a microbiological sample will be collected for evaluation. |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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)
|
12/01/2026 |
| 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="1"
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
|
AIMS TO COMPARE THE ANTIMICROBIAL EFFICACY OF BIOCERAMIC-BASED INTRACANAL MEDICAMENT, CALCIUM HYDROXIDE WITH IODOFORM PASTE, AND PROBIOTIC PASTE WITH SALINE AGAINST ENTEROCOCCUS FAECALIS ROOT CANAL INFECTIONS IN PERMANENT ANTERIOR TEETH OFTEN INVOLVE MIXED BACTERIA, WITH ENTEROCOCCUS FAECALIS BEING A COMMON PATHOGEN. ITS CAPABILITY TO ADHERE TO AND PENETRATE DENTIN, FORM BIOFILMS, AND TOLERATE HIGH PH VALUES MAKES IT RESISTANT TO MANY ANTIMICROBIALS. THOROUGH ERADICATION OF E. FAECALIS AND OTHER MICROORGANISMS DURING ROOT CANAL TREATMENT IS CRUCIAL TO PREVENT REINFECTION AND ENSURE SUCCESSFUL TREATMENT OUTCOMES. IN OUR STUDY WE WILL BE COMPAIRING THE ANTIMICROBIAL EFFICACY OF BIOCERAMIC BASED INTRACANAL MEDICAMENT CALCIUM HYDROXIDE WITH IODOFORM PASTE AND PROBIOTIC PASTE WITH SALINE. |