| CTRI Number |
CTRI/2025/07/090315 [Registered on: 07/07/2025] Trial Registered Prospectively |
| Last Modified On: |
04/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Effect Of Newer Agents In Maintaining Pulp Vitality |
|
Scientific Title of Study
|
Comparative Assessment Of Various Innovative Pulp Capping Agents For Treatment Of Partial Pulpotomy : An In Vivo Study |
| Trial Acronym |
Nill |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ekta Chaudhari |
| Designation |
Assistant Professor |
| Affiliation |
Siddhpur Dental college |
| Address |
Department of Conservative Dentistry and Endodontics Room No 4 Siddhpur Dental College Dethli Siddhpur pin coad 384151
Department of Conservative Dentistry and Endodontics Room No 4 Siddhpur Dental College Dethli Siddhpur pin coad 384151
Patan
GUJARAT
383430
India |
| Phone |
9427824242 |
| Fax |
|
| Email |
ekta878@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shikha Kanodia |
| Designation |
Professor |
| Affiliation |
Govt Dental College and Hospital |
| Address |
Department of conservative dentistry and endodontics,room no 4, govt dental
college and hospital, civil hospital campus,
asarwa,ahmedabad.380016 Ahmadabad GUJARAT India
Department of conservative dentistry and endodontics, room no 4, govt dental
college and hospital, civil hospital campus,
asarwa,ahmedabad.380016 Ahmadabad GUJARAT India
Ahmadabad
GUJARAT
382424
India |
| Phone |
9825465861 |
| Fax |
|
| Email |
Shikhakk@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Ekta Chaudhari |
| Designation |
Assistant Professor |
| Affiliation |
Siddhpur Dental college |
| Address |
Department of Conservative Dentistry and Endodontics room no 4, Siddhpur Dental College Dethli Siddhpur pin coad 384151
Department of Conservative Dentistry and Endodontics ,room no 4, Siddhpur Dental College Dethli Siddhpur pin coad 384151
Patan
GUJARAT
383430
India |
| Phone |
09427824242 |
| Fax |
|
| Email |
ekta878@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Conservative Dentistry and Endodontics, Siddhpur Dental College and Hospital ,Gujarat 384151 |
|
|
Primary Sponsor
|
| Name |
Siddhpur Dental College and Hospital |
| Address |
Siddhpur Dental College and Hospital Dethli Siddhpur
pin coad 384151 |
| Type of Sponsor |
Other [Siddhpur Dental College 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 Ekta Chaudhari |
Siddhpur Dental College and Hospital |
Room No 4 Department of Conservative Dentistry and Endodontics
Patan
GUJARAT |
09427824242
ekta878@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE Govt. Dental College Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K049||Other and unspecified diseases ofpulp and periapical tissues, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Different pulp capping agents will be used in the study |
1)Identify the various bioactive material MTA, simvastatin , biodegradable scaffold PRF and Bioaggregate
used in pulpotomy clinical trials in permanent teeth and compare amongst them.
2)To Evaluate the clinical and radiographic success of partial pulpotomy over observation period of 1 month and 6 month 12 month |
| Intervention |
Partial Pulpotomy Treatment |
Partial Pulpotomy will be done with four different pulp capping agents named
1)MTA plus for 12 months
2)Bio Aggregatebio for 12 month
3)Simvastatin for 12 months
4)PRF for 12 months |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Participants free from any systemic disease.
2)Deep caries in a permanent molar with mature roots.
3)Probing pocket depth and mobility within normal limits.
4)No signs of pulpal necrosis including sinus tract or swelling.
5)The tooth is restorable.
6)Clinical diagnosis of symptomatic irreversible pulpitis based on subjective and objective examinations
7)The teeth that will be included should have the periapical index score 1 or 2
|
|
| ExclusionCriteria |
| Details |
1)Negative response to cold testing.
2)No pulp exposure after caries excavation.
3)Bleeding could not be controlled in 10 minutes after 2.5% NaOCl
4)Absence of bleeding from any of the canals.
5)Teeth with radiographic signs of internal resorption.
6)Pulpal calcifications
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Assessment of postoperative pain using Numerical rating scale (NRS) The patient would be asked to mark the scale on a pain evaluation sheet starting from 0 “no pain” to 10 “worst imaginable pain” at 3 and 6 months after treatment
|
assesment will be done at interval of 3 month 6 month 12 month
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Dentin bridge formation on post operative radiograph assesment. |
6month and 12 month |
|
|
Target Sample Size
|
Total Sample Size="180"
Sample Size from India="180"
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)
|
30/07/2025 |
| 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="3"
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
|
COMPARATIVE ASSESSMENT OF VARIOUS INNOVATIVE PULP CAPPING AGENTS FOR TREATMENT OF PARTIAL PULPOTOMY : AN IN VIVO STUDY Aim:To asses the effects of different pulpotomy agents on the functional and structural recovery of the pulp-dentin complex Objective: 1)Identify the various bioactive material MTA, simvastatin and biodegradable scaffold PRF Bioaggregate used in pulpotomy clinical trials in permanent teeth and compare amongst them. 2)To Evaluate the clinical and radiographic success of partial pulpotomy over observation period of 1 month 6 month and 12 month |