| CTRI Number |
CTRI/2024/10/075607 [Registered on: 22/10/2024] Trial Registered Prospectively |
| Last Modified On: |
16/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Checking the difference between various intracanal irrigants like 2% Chlorhexidine, 25% aqueous extract of Propolis and Curcuma Longa extract efficacy. |
|
Scientific Title of Study
|
The comparison of antimicrobial effectiveness of 2% chlorhexidine, 25% aqueous extract of propolis and Curcuma Longa extract as intracanal irrigants: an ex 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 |
Upasana Sengupta |
| Designation |
MDS II year |
| Affiliation |
Maharishi Markandeshwar Deemed to be University |
| Address |
Room no.-4,Pediatric and Preventive dentistry, Maharishi Markandeshwar College of Dental Sciences and Research, Maharishi Markandeshwar Deemed to be University, Mullana, Ambala
Maharishi Markandeshwar College of Dental Sciences and Research, Maharishi Markandeshwar Deemed to be University, Mullana, Ambala
Ambala
HARYANA
133207
India |
| Phone |
9731974332 |
| Fax |
|
| Email |
usg0202@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. H.P Suma Sogi |
| Designation |
Professor and Head of Department |
| Affiliation |
Maharishi Markandeshwar Deemed to be University |
| Address |
Room no.4,Pediatric and Preventive Dentistry, Maharishi Markandeshwar College of Dental Sciences and Research, Maharishi Markandeshwar Deemed to be University, Mullana, Ambala
Ambala
HARYANA
133207
India |
| Phone |
6206582298 |
| Fax |
|
| Email |
hpsumasogi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Upasana Sengupta |
| Designation |
MDS II year |
| Affiliation |
Maharishi Markandeshwar Deemed to be University |
| Address |
Room no.4,Pediatric and Preventive Dentistry, Maharishi Markandeshwar College of Dental Sciences and Research, Maharishi Markandeshwar Deemed to be University, Mullana, Ambala
Ambala
HARYANA
133207
India |
| Phone |
9731974332 |
| Fax |
|
| Email |
usg0202@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room no.4, Pediatric and Preventive Dentistry, Maharishi Markandeshwar College of Dental Science and Research, Maharishi Markandeshwar Deemed to be University, Mullana, Ambala |
|
|
Primary Sponsor
|
| Name |
Upasana Sengupta |
| Address |
Room no.4,Pediatric and Preventive Dentistry, Maharishi Markandeshwar College of Dental sciences and Research, Maharishi Markandeshwar Deemed to be University, Mullana, Ambala |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Upasana Sengupta |
Maharishi Markandeshwar College of Dental Sciences and Research |
Room no.4, Pediatric and Preventive Dentistry, Maharishi Markandeshwar Deemed to be University, Mullana, Ambala
Ambala
HARYANA |
9731974332
usg0202@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE,MM INSTITUTE OF MEDICAL SCIENCES AND RESEARCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K029||Dental caries, unspecified. Ayurveda Condition: KAVALA-ATIYOGAH, (2) ICD-10 Condition:K040||Pulpitis. Ayurveda Condition: KAVALA-ATIYOGAH, (3) ICD-10 Condition:K040||Pulpitis. Ayurveda Condition: KAVALA-ATIYOGAH, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
1. 2% Chlorehexidine
2. 25% aqueous extract of Propolis
3. Curcuma longa extract |
1. 2% chlorehexidine will be used once for each patient with 2 ml syringe during pulpectomy
2. 25% aqueous extract of Propolis will be used once for each patient with 2 ml syringe during pulpectomy
3. Curcuma longa extract will be used once for each patient with 2 ml syringe during pulpectomy |
| Comparator Agent |
Saline |
Saline will be used once for each patient with 2ml syringe during pulpectomy |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
7.00 Year(s) |
| Gender |
Both |
| Details |
good general health
no history of antibiotic coverage
radiographic evidence of carious pulp exposure in primary teeth |
|
| ExclusionCriteria |
| Details |
internal or external root resorption
physiological resorption upto one third root length of the selected tooth |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To see the antimicrobial effect (through culture) of 2% Chlorehexidine , 25% aqueous extract of Propolis and Curcuma longa extract
|
All the samples will be sent for culture immediately after the procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The study will be conducted only at baseline.There will be no follow-up. |
only baseline |
1. Chlorohexidine will have significantly higher antimicrobial effect on microorganisms than 25% aqueous propolis & Curcuma longa extract.
2. 25% aqueous propolis extract will have significantly higher antimicrobial effect on microorganisms than 2% chlorohexidine & Curcuma longa extract.
3. Curcuma longa extract will have significantly higher antimicrobial effect on microorganisms than 2% chlorohexidine & 25% aqueous propolis extract. |
1. at baseline
2. at baseline
3. at baseline |
|
|
Target Sample Size
|
Total Sample Size="12"
Sample Size from India="12"
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 1 |
|
Date of First Enrollment (India)
|
10/11/2024 |
| 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="2"
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
|
My study is to compare and evaluate antimicrobial effect of 2% chlorhexidine, 25% aqueous propolis extract and Curcuma longa as an intra canal irrigant on Streptococcus mutans, Staphylococcus, Enterococcus faecalis and Escherichia coli in deciduous teeth. |