| CTRI Number |
CTRI/2025/03/083089 [Registered on: 21/03/2025] Trial Registered Prospectively |
| Last Modified On: |
20/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To Compare Antimicrobial efficacy of DAP with distilled water, 2 percent Chlorhexidine and Bioceramic based medicament as intracanal medicament in children of age 4-11 years
|
|
Scientific Title of Study
|
Comparative evaluation of antimicrobial efficacy of double antibiotic paste with distilled water double antibiotic paste with 2 percent chlorhexidine and bioceramic based intracanal medicament against e. Faecalis in primary 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 SHWETA |
| Designation |
MDS STUDENT |
| Affiliation |
Pandit Bhagwat Dayal Sharma University of Health Sciences, Rohtak |
| Address |
Room number 6, Department of Pedodontics, Sudha Rustagi Dental College, Faridabad
Room number 6, Department of Pedodontics, Sudha Rustagi Dental College, Faridabad
Faridabad
HARYANA
121002
India |
| Phone |
09871290096 |
| Fax |
|
| Email |
shwetabhamania@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR NEHA SHEORAN |
| Designation |
PROFESSOR |
| Affiliation |
Pandit Bhagwat Dayal Sharma University of Health Sciences, Rohtak |
| Address |
Room number 6, Department of Pedodontics, Sudha Rustagi Dental College, Faridabad
Room number 6, Department of Pedodontics, Sudha Rustagi Dental College, Faridabad
Faridabad
HARYANA
121002
India |
| Phone |
09711544829 |
| Fax |
|
| Email |
sheoran.neha@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
DR SHWETA |
| Designation |
MDS STUDENT |
| Affiliation |
Pandit Bhagwat Dayal Sharma University of Health Sciences, Rohtak |
| Address |
Room number 6, Department of Pedodontics, Sudha Rustagi Dental College, Faridabad
Room number 6, Department of Pedodontics, Sudha Rustagi Dental College, Faridabad
Faridabad
HARYANA
121002
India |
| Phone |
09871290096 |
| Fax |
|
| Email |
shwetabhamania@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sudha Rustagi College of Dental Sciences and Research, Faridabad, Haryana, 121002 |
|
|
Primary Sponsor
|
| Name |
DR SHWETA |
| Address |
H.no. 358, Sector 17, District Faridabad, State Haryana, Country India, Pin code 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 Shweta |
Sudha Rustagi Dental College,Faridabad |
Sudha Rustagi College of Dental Sciences and Research, Faridabad
Faridabad
HARYANA |
09871290096
shwetabhamania@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRCDSR-IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Primary teeth indicated for pulpectomy |
| Patients |
(1) ICD-10 Condition: K027||Dental root caries, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bioceramic based Intracanal Medicament |
A new material as intracanal medicament, For Intervention 7 days time period is required for placement of medicament as intracanal medicament |
| Comparator Agent |
Double antibiotic paste with distilled water, Double antibiotic paste with 2% Chlorhexidine |
Gold standard, 7 days time period is required for placement of medicament as intracanal medicament |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
11.00 Year(s) |
| Gender |
Both |
| Details |
It will be comprised of subjects whose parents will give the informed consent.
1.Primary teeth with open carious lesions with exposure of pulp.
2.Teeth with minimal periapical changes with sufficient bone support.
3.Teeth having clinically and radiographically sufficient crown.
4.At least 2/3rd of root length available.
5.Subjects who had not taken any antibiotics in the last 3 months preceding the treatment will be incorporated in the study
|
|
| ExclusionCriteria |
| Details |
1.Presence of signs such as prolonged or spontaneous pain, pathological mobility (Miller Grade II or more), sensitivity to percussion.
2.The medically compromised patients and patients on antibiotics within three months will be excluded from the study.
3.Non restorable tooth / Perforation of pulpal floor.
4.Radiographic signs of internal/external root resorption.
5.Previously endodontically treated teeth.
6.Involvement of permanent tooth bud.
7.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 |
Baseline, difference in Microbial Count of E.Faecalis after access opening and after BMP |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Decrease in E. Faecalis Count |
Decrease in E. Faecalis Count after 1 week placement of intracanal medicament (double antibiotic paste with normal saline/ double antibiotic paste with 2% chlorhexidine/ bioceramic based intracanal medicament) |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
31/03/2025 |
| 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="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
|
AIM: TO COMPARE ANTIMICROBIAL EFFICACY OF DOUBLE ANTIBIOTIC PASTE WITH DISTILLED WATER, DOUBLE ANTIBIOTIC PASTE WITH 2% CHLORHEXIDINE SOLUTION, AND BIOCERAMIC BASED INTRACANAL MEDICAMENT AGAINST E. FAECALIS. ROOT CANAL INFECTIONS IN PRIMARY 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 PULPECTOMY 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 WITH DIFFERENT COMBINATIONS OF DOUBLE ANTIBIOTIC. |