| CTRI Number |
CTRI/2025/02/081146 [Registered on: 21/02/2025] Trial Registered Prospectively |
| Last Modified On: |
21/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparing the effectiveness of cold Triphala against commonly used solutions in reducing pain after Root Canal treatment in children. |
|
Scientific Title of Study
|
Comparative evaluation of post endodontic pain reduction by cryotreated Triphala against conventionally used irrigant in primary teeth |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Arshjot Singh Basra |
| Designation |
Intern |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
203, Department of Pediatric and Preventive Dentistry, Sharad Pawar Dental College and Hospital, Sawangi
Wardha
MAHARASHTRA
442001
India |
| Phone |
09822870923 |
| Fax |
|
| Email |
arshbasra9@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nilima Ramdas Thosar |
| Designation |
Head of Department |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
203, Department of Pediatric and Preventive Dentistry, Sharad Pawar Dental College and Hospital, Sawangi, Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9422163632 |
| Fax |
|
| Email |
drnthosar@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nilima Ramdas Thosar |
| Designation |
Head of Department |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
203, Department of Pediatric and Preventive Dentistry, Sharad Pawar Dental College and Hospital, Sawangi, Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9422163632 |
| Fax |
|
| Email |
drnthosar@rediffmail.com |
|
|
Source of Monetary or Material Support
|
|
Datta Meghe Institute of Higher Education and Research, Sawangi Meghe, Wardha, India 442001 |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Research |
| Address |
Sawangi Meghe, Wardha, India 442001 |
| 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 |
| Dr Arshjot Singh Basra |
Sharad Pawar Dental College and Hospital |
203, Department of Pediatric and Preventive Dentistry, Sharad Pawar Dental College and Hospital, Sawangi
Wardha
MAHARASHTRA |
9822870923
arshbasra9@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute of Higher Education and Research |
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 |
| Comparator Agent |
Cryotreared saline |
Cryotreated saline will be used as an Endodontic irrigant for 30 minutes of root canal treatment in each of the 9 teeth. |
| Intervention |
Cryotreated Triphala |
Crotreated Triphala will be used as endodontic irrigant for 30 minutes of root canal treatment in each of the 9 teeth. |
| Comparator Agent |
Normal saline |
Normal saline will be used as an Endodontic irrigant for 30 minutes of root canal treatment in each of the 9 teeth. |
| Intervention |
Normal Triphala Solution |
Normal triphala solution will be used as endodontic irrigant for 30 minutes of root canal treatment in each of the 9 teeth. |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
7.00 Year(s) |
| Gender |
Both |
| Details |
1. symptoms of irreversible pulpitis.
2. Radiographic confirmation of carious lesion nearing or affecting the pulp.
3. At least 2/3rd of the root length present. |
|
| ExclusionCriteria |
| Details |
1. Individuals aged less/ more than age of 4-7 years.
2. uncooperative individuals.
3. Individuals suffering from any systemic disease. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome of the study is to access the Effectiveness of cryotherapy and triphala as an intracanal irrigant in reducing post-endodontic pain |
Assessment will be done before treatment, immediately after treatment and post 24 hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NA |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
15/03/2025 |
| 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 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
|
The most widely irrigant currently is sodium hypochlorite, however it has been associated with many adverse effects such as tissue toxicity, shortcoming to remove smear layer, unlikeable taste and smell. Therefore, new material and therapies which could overcome such setbacks have been explored which include cryotherapy and medicinal herbs such as Triphala and Circumin. Cryotherapy has reportedly proven effective in reducing swelling and pain following periodontal surgery, extractions, and implant augmentation, therefore its potential as an intracanal irrigant needs to be explored, eventhough currently it is still a matter of speculation. This study will be implemented at Sharad Pawar Dental College in Wardha, Maharashtra, India in the Department of Paediatric and Preventive Dentistry. A total of 80 primary teeth will be included in the study, which will be divided in 4 Groups( 20 subjects in each group). This study will evaluate and compare the effectiveness of cryotreated triphala with conventionally used normal saline as root canal irrigant for reducing post endodontic pain in primary teeth. |