| CTRI Number |
CTRI/2025/02/081161 [Registered on: 24/02/2025] Trial Registered Prospectively |
| Last Modified On: |
21/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Chlorhexidine VS Apple Cider Vinegar : Which is better for fighting bacteria in kids Root Canals? |
|
Scientific Title of Study
|
Comparative Evaluation of Antimicrobial Efficacy of 2% Chlorhexidine and Apple Cider Vinegar as Root Canal Irrigants Against Enterococcus 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 Sreelekshmy K G |
| Designation |
Post Graduate Student |
| Affiliation |
Department Of Pediatric and Preventive Dentistry, PMS College Of Dental Science and Research, |
| Address |
"Narayaneeyam",
MLR-67, Mangalam Lane, Sasthamangalam ,
Pincode : 695010
Thiruvananthapuram
KERALA
695010
India |
| Phone |
9400544013 |
| Fax |
|
| Email |
drsreelekshmykg15@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sreelekshmy K G |
| Designation |
Post Graduate Student |
| Affiliation |
Department of Pediatric and Preventive Dentistry, PMS College of Dental Science and Research |
| Address |
"Narayaneeyam",
MLR-67, Mangalam Lane, Sasthamangalam,
Pincode : 695010
Thiruvananthapuram
KERALA
695010
India |
| Phone |
9400544013 |
| Fax |
|
| Email |
drsreelekshmykg15@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sreelekshmy K G |
| Designation |
Post Graduate Student |
| Affiliation |
Department of Pediatric and Preventive Dentistry, PMS College of Dental Science and Research |
| Address |
"Narayaneeyam",
MLR-67, Mangalam Lane, Sasthamangalam,
Pincode : 695010
Thiruvananthapuram
KERALA
695010
India |
| Phone |
9400544013 |
| Fax |
|
| Email |
drsreelekshmykg15@gmail.com |
|
|
Source of Monetary or Material Support
|
| PMS COLLEGE OF DENTAL SCIENCE
Golden Hills, Vattappara, Venkode, Thiruvananthapuram, Kerala, India.
Pincode : 695028 |
|
|
Primary Sponsor
|
| Name |
SREELEKSHMY K G |
| Address |
Narayaneeyam, MLR-67, Mangalam Lane, Sasthamangalam, Thiruvananthapuram.
Kerala, India.
Pincode: 695010 |
| Type of Sponsor |
Other [FUNDED BY 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 SREELEKSHMY K G |
PMS COLLEGE OF DENTAL SCIENCE AND RESEARCH |
Department of Pediatric and Preventive Dentistry
Thiruvananthapuram
KERALA |
9400544013
drsreelekshmykg15@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
2% CHLORHEXIDINE |
Chlorhexidine is a chemical used as root canal irrigant due to broas spectrum antimicrobial activity, substantivity and low cytotoxicity. |
| Intervention |
APPLE CIDER VINEGAR |
Apple cider vinegar exhibit high antibacterial properties and can remove smear layer and soften root canal walls. |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
Non vital primary teeth.
Primary teeth with no physiologic mobility.
Primary teeth with minimum root resorption.
Patients with good general health and lack of any systemic diseases.
Patients who parents give consent |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| COLONY FORMING UNITS ARE MEASURED |
Initial Colony forming units will be assessed after access opening of molar tooth.
Final colony forming units assessed after irrigation with each irrigants.
All samples are asssesed for colony forming units within 2 hours of start of procedure. |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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)
|
10/03/2025 |
| 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="6"
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
|
This study evaluates antimicrobial efficacy of 2% Chlorhexidine and apple cider vinegar as root canal irrigants in pediatric root canal treatment. After informed consent and verbal assent, eligible children will be allocated into two groups by block randomization. Group 1: 2% Chlorhexidine group Group 2 : Apple cider vinegar group. After Local anesthesia administration, tooth will be isolated using rubber dam. Following access opening and pulp extripation, microbial samples (S1) will be taken using sterile paper points and transferred to Brain Heart Infusion broth.Each canal will be irrigated with either 10 mL of 2% Chlorhexidine or Apple Cider Vinegar, followed by a second microbial sample (S2). A final rinse with 3% Sodium Hypochlorite and saline will be performed, and the canals will be dried and obturated. Stainless steel crowns will be placed for final restoration. Microbiological analysis of E. faecalis will be conducted by culturing samples on Mitis Salivarius Agar. Colony Forming Units (CFU/ml) will be counted using a Digital Colony Counter, and bacterial identification will be confirmed through Gram staining, catalase testing, and colony morphology. Statistical analysis will determine the efficacy of both irrigants in bacterial reduction. |