| CTRI Number |
CTRI/2023/07/055519 [Registered on: 21/07/2023] Trial Registered Prospectively |
| Last Modified On: |
20/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Premixed Injectable MTA for Pulpotomy of Primary Teeth |
|
Scientific Title of Study
|
Evaluation of clinical and radiographic outcome of premixed injectable MTA and conventional MTA as pulpotomy medicament in primary teeth : A split mouth randomised control trial |
| Trial Acronym |
PIMTAP |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrAIswarya U S |
| Designation |
1st year Post Graduate |
| Affiliation |
Yenepoya Dental College and Hospital |
| Address |
17 Auditor Street
Eswar Nagar
Podanur
Coimbatore
Yenepoya Dental College and Hospital
Deralakatte
Mangalore
575018
Coimbatore
TAMIL NADU
641023
India |
| Phone |
8220083144 |
| Fax |
|
| Email |
aishuaish59@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sharan Sargod |
| Designation |
Professor and HOD |
| Affiliation |
Yenepoya Dental College and Hospital |
| Address |
Department of Pediatric and Preventive Dentistry
Yenepoya Dental College and Hospital
Deralakatte
Mangalore
575018
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9845120885 |
| Fax |
|
| Email |
Sharansargod@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
DrAIswarya U S |
| Designation |
1st year Post Graduate |
| Affiliation |
Yenepoya Dental College and Hospital |
| Address |
17 Auditor Street
Eswar Nagar
Podanur
Coimbatore
Yenepoya Dental College and Hospital
Deralakatte
Mangalore
575018
Coimbatore
TAMIL NADU
641023
India |
| Phone |
8220083144 |
| Fax |
|
| Email |
aishuaish59@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Pediatric and Preventive Dentistry, Yenepoya Dental college |
|
|
Primary Sponsor
|
| Name |
AISWARYA U S |
| Address |
Yenepoya Dental College and Hospital
Deralakatte
Mangalore 575018 |
| 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 Aiswarya U S |
Yenepoya Dental College |
Department of Pedaitric and Preventive Dentistry, Yenepoya Dental College and Hospital
Deralakatte
Mangalore 575018
Dakshina Kannada
KARNATAKA |
8220083144
aishuaish59@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Yenepoya Ethics Committee 2 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Dental caries indicated for Pulpotomy without irreversible pulpal damage |
| Patients |
(1) ICD-10 Condition: K040||Pulpitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional MTA. To be mixed as manufacturers instruction |
Conventional MTA is used as a routine pulpotomy medicament and the clinical and radiographic outcomes of it with Premixed Injectable MTA are evauated |
| Intervention |
Premixed injectable MTA which is injected into the pulp chamber |
Premixed Injectable MTA contains MTA which is a routinely used pulpotomy medicament which is in the premixed Injectable form |
|
|
Inclusion Criteria
|
| Age From |
5.00 Month(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
Children with bilateral indication for pulpotomy without signs and symptoms of irreversible pulpal damage |
|
| ExclusionCriteria |
| Details |
Children with irreversible pulpal damage, sinus or fistula and children with systemic diseases |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Injecatble form of MTA can be used as a Pulpotomy Medicament in Primary teeth. Clinical and radiographic assessment will be done. |
Over a period of 6 months and one year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Clinical & radiographic outcome of the pulpotomy with premixed injectable MTA will be assessed over a follow up period |
12 months |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
Final Enrollment numbers achieved (Total)= "17"
Final Enrollment numbers achieved (India)="17" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
22/07/2023 |
| Date of Study Completion (India) |
31/03/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Pulpotomy is vital endodontic procedure done to maintain the integrity of the radicular pulp. This study will be done to evaluate the clinical and radiographic outcome of Premixed Injectable MTA and Conventional MTA as pulpotomy medicament in primary teeth. |