| CTRI Number |
CTRI/2024/07/069706 [Registered on: 01/07/2024] Trial Registered Prospectively |
| Last Modified On: |
28/06/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
An In Vivo Study to Evaluate and Compare the Chitosan nanoparticle solution, 2% Chlorhexidine, and Normal Saline as Root Canal Irrigants in primary teeth. |
|
Scientific Title of Study
|
COMPARATIVE EVALUATION OF ANTIMICROBIAL EFFICACY OF CHITOSAN NANOPARTICLES, CHLORHEXIDINE AND NORMAL SALINE AGAINST E. FAECALIS AS ROOT CANAL IRRIGANTS IN PRIMARY TEETH- 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 |
PARUL GARG |
| Designation |
MDS 2ND YEAR |
| Affiliation |
Sudha Rustagi College of Dental Sciences and Research Haryana |
| Address |
ROOM NO. 6, DEPARTMENT OF PEDODONTICS, SUDHA RUSTAGI DENTAL COLLEGE, FARIDABAD
Faridabad
HARYANA
121002
India |
| Phone |
9306242526 |
| Fax |
|
| Email |
parulgarg281998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
NEHA SHEORAN |
| Designation |
PROFESSOR |
| Affiliation |
PT. BD SHARMA UNIVERSITY |
| Address |
ROOM NO. 6, DEPARTMENT OF PEDODONTICS, SUDHA RUSTAGI DENTAL COLLEGE, FARIDABAD
Faridabad
HARYANA
121002
India |
| Phone |
9711544829 |
| Fax |
|
| Email |
sheoran.neha@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
NEHA SHEORAN |
| Designation |
PROFESSOR |
| Affiliation |
Sudha Rustagi College of Dental Sciences and Research Haryana |
| Address |
ROOM NO. 6, DEPARTMENT OF PEDODONTICS, SUDHA RUSTAGI DENTAL COLLEGE, FARIDABAD
HARYANA
121002
India |
| Phone |
9711544829 |
| Fax |
|
| Email |
sheoran.neha@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Sudha Rustagi College of Dental Sciences and Research, Faridabad, 121002 |
|
|
Primary Sponsor
|
| Name |
DR PARUL GARG |
| Address |
c-1/10, sector 85, faridabad, haryana, 121002 |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| DR PARUL GARG |
c-1/10, sector 85, faridabad |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| PARUL GARG |
SUDHA RUSTAGI COLLEGE OF DENTAL SCIENCES AND RESEARCH |
Room no. 6, Department of Pedodontics, Sudha Rustagi Dental College, Faridabad, Haryana
Faridabad
HARYANA |
9306242526
parulgarg281998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRCDSR-INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K029||Dental caries, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
CHITOSAN NANOPARTICLE SOLUTION AND 2% CHLORHEXIDINE |
THE SAMPLES WILL BE TAKEN AT BASELINE AND AFTER IRRIGATING THE CANALS DURING PULPECTOMY
THE STUDY WILL TAKE 1 MONTH |
| Comparator Agent |
NORMAL SALINE |
IT IS COMMONLY USED AND SAMPLE WILL BE TAKEN PRE AND POST IRRIGATION DURING PULPECTOMY
THE STUDY WILL TAKE 1 MONTH |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
• It will be comprised of subjects willing to participate in the study.
• Presence of signs such as prolonged or spontaneous pain, pathological mobility, sensitivity to percussion.
• Patients requiring endodontic treatment in primary teeth with at least two third of total root length remaining were included in the study.
|
|
| ExclusionCriteria |
| Details |
• The medically compromised patients and patients on antibiotics within three months will be excluded from the study.
• Patients who are not willing to participate
|
|
|
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 and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| antimicrobial efficacy chitosan nanoparticle, 2% chlorhexidine and normal saline as root canal irrigants |
AT BASELINE AND SAME DAY AFTER IRRIGATION |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| anitimicrobial efficacy against E. faecalis |
AT BASELINE (PRE IRRIGATION) AND SAME AFTER AFTER IRRIGATION |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
Final Enrollment numbers achieved (Total)= "45"
Final Enrollment numbers achieved (India)="45" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
10/07/2024 |
| Date of Study Completion (India) |
02/01/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
The aim of this study is to evaluate and compare antimicrobial efficacy of chitosan nanoparticles solution, chlorhexidine and normal saline against E. Faecalis as root canal irrigants in primary teeth. |