| CTRI Number |
CTRI/2025/07/090038 [Registered on: 02/07/2025] Trial Registered Prospectively |
| Last Modified On: |
11/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Can herbal solutions replace chemicals in children’s root canal treatments? |
|
Scientific Title of Study
|
Comparative evaluation of post operative pain,radiographic and clinical successes of noval herbal irrigant and sodium hypochlorite during pulpectomy of lower molars |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mithula Raj |
| Designation |
Post Graduate Student |
| Affiliation |
Saveetha Dental College and Hospitals |
| Address |
Saveetha Dental College and Hospitals
Department of Pedodontics and
Preventive dentistry
162,Poonamallee high road, Velappanchavadi
Chennai
TAMIL NADU
600077
India |
| Phone |
9539655505 |
| Fax |
|
| Email |
mithularaj96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Deepa Gurunathan |
| Designation |
Head of the Department |
| Affiliation |
Saveetha Dental College and Hospitals |
| Address |
Saveetha Dental College and Hospitals
Department of Pedodontics and Preventive dentistry
162,Poonamallee High Road, Velappanchavadi
Chennai
TAMIL NADU
600077
India |
| Phone |
09994619386 |
| Fax |
|
| Email |
deepag@saveetha.com |
|
Details of Contact Person
Public Query
|
| Name |
Mithula Raj |
| Designation |
Post Graduate Student |
| Affiliation |
Saveetha Dental College and Hospitals |
| Address |
Saveetha Dental College and Hospitals
Department of Pedodontics and Preventive dentistry
162,Poonamallee High Road, Velappanchavadi
Chennai
TAMIL NADU
600077
India |
| Phone |
9539655505 |
| Fax |
|
| Email |
mithularaj96@gmail.com@saveetha.com |
|
|
Source of Monetary or Material Support
|
| Saveetha Dental College and Hospitals
162,Poonamallee High Road, Velappanchavadi,Chennai |
|
|
Primary Sponsor
|
| Name |
Saveetha Dental College and Hospitals |
| Address |
Saveetha Dental College and Hospitals
162,Poonamallee High Road, Velappanchavadi,Chennai
|
| Type of Sponsor |
Private medical college |
|
|
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 |
| Mithula Raj |
Saveetha dental college and hospitals |
Clinic 28
Department of pedodontics and preventive dentistry
Chennai
Chennai
TAMIL NADU |
9539655505
mithularaj96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethical Committee Certificate (SDC-IHEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K040||Pulpitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Noval herbal irrigant |
A novel herbal irrigant combining triphala, soap nut, probiotics, and grape seed extract offers a natural alternative to chemical irrigants in pediatric pulpectomy. |
| Comparator Agent |
Sodium hypochlorite |
Sodium hypochlorite (NaOCl) is a widely used root canal irrigant in endodontic procedures due to its excellent antimicrobial activity and ability to dissolve organic tissue. |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
Children who need bilateral pulpectomy of primary mandibular molars
Healthy children
|
|
| ExclusionCriteria |
| Details |
Children with single tooth lower molar pulpectomy
Medically compromised children
Tooth indicated for extraction |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Post operative pain
Clinical success
Radiographic success |
Post operative pain -baseline,6hours,12 hours,24 hours,72 hours
Clinical success - baseline , 3 months , 6 months
Radiographic success- baseline,3 months,6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="49"
Sample Size from India="49"
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 4 |
|
Date of First Enrollment (India)
|
16/07/2025 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
In pediatric dentistry, pulpectomy is a common procedure used to treat infected primary teeth. Effective root canal irrigation is essential for eliminating microorganisms and ensuring treatment success. While sodium hypochlorite is the standard irrigant due to its strong antimicrobial action, its drawbacks such as tissue toxicity and unpleasant taste have prompted interest in herbal alternatives. Natural agents like triphala, soap nut, probiotics, and grape seed extract are being explored for their antimicrobial, anti-inflammatory, and healing properties, offering a potentially safer and biocompatible solution for root canal disinfection in children. |