| CTRI Number |
CTRI/2024/06/068984 [Registered on: 18/06/2024] Trial Registered Prospectively |
| Last Modified On: |
14/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparision of three materials used after pulp therapy |
|
Scientific Title of Study
|
Preserving Vitality-
Comparative evaluation of three bioactive materials used in pulpotomy of mature permanent 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 |
Mohil Kale |
| Designation |
PG Student |
| Affiliation |
College Of Dental Sciences And Research Center |
| Address |
Room No. 7, Department of Conservative Dentistry and Endodontics, College Of Dental Sciences And Research Center, Manipur, Ghuma, Ahmedabad
Ahmadabad
GUJARAT
380058
India |
| Phone |
9726817619 |
| Fax |
|
| Email |
mohilkale@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nishtha Patel |
| Designation |
Professor and PG Guide |
| Affiliation |
College Of Dental Sciences And Research Center |
| Address |
Room No. 7, Department of Conservative Dentistry and Endodontics, College Of Dental Sciences And Research Center, Manipur, Ghuma, Ahmedabad
Ahmadabad
GUJARAT
380058
India |
| Phone |
9712994610 |
| Fax |
|
| Email |
dr.nkp.2557@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nishtha Patel |
| Designation |
Professor and PG Guide |
| Affiliation |
College Of Dental Sciences And Research Center |
| Address |
Room No. 7, Department of Conservative Dentistry and Endodontics, College Of Dental Sciences And Research Center, Manipur, Ghuma, Ahmedabad
GUJARAT
380058
India |
| Phone |
9712994610 |
| Fax |
|
| Email |
dr.nkp.2557@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Conservative Dentistry and Endodontics, College Of Dental Sciences And Research Center |
|
|
Primary Sponsor
|
| Name |
Mohil Kale |
| Address |
Room No. 7, Department of Conservative Dentistry and Endodontics, College Of Dental Sciences And Research Center, Manipur, Ghuma, Ahmedabad, Gujarat |
| Type of Sponsor |
Other [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 Mohil Kale |
College of Dental Sciences and Research center |
Room No.7, Department of Conservative Dentistry And Endodontics, College of Dental Sciences And Research Center, Manipur, Near Bopal
Ahmadabad
GUJARAT |
9726817619
mohilkale@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, College Of Dental Sciences And Research Center |
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 |
| Comparator Agent |
Bioceramic putty |
2 mm of bioceramic putty is applied on floor of the pulp chamber after coronal pulpotomy for 1 year |
| Comparator Agent |
Biodentine |
2 mm of Biodentine is applied on the pulp floor after coronal pulpotomy for 1 year |
| Intervention |
Mineral Trioxide Aggregate (MTA) |
2mm of MTA is applied on the floor of pulp chamber after coronal pulpotomy for 1 year |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Mandibular molars with caries extending to pulp and having symptoms of irreversible pulpitis with positive response to vitality tests (Cold test+EPT) |
|
| ExclusionCriteria |
| Details |
Teeth that will not respond to vitality tests (Cold+EPT)
Teeth with periapical involvement
Individuals having Systemic diseases or on antibiotics
Teeth having excessive bleeding after cavity preparation (Haemostasis not achieved within 5 minutes of coronal pulp removal)
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction of pain measured by VAS score |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Elimination of pain measured by VAS score |
After 7 days, 1 month, 3 months, 6 months, 1 year |
| No pathosis evident on radiograph |
After 7 days, 1 month, 3 months, 6 months, 1 year |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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 |
|
Date of First Enrollment (India)
|
01/07/2024 |
| 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 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
|
Until recently, the pulp of mature tooth exposed by caries was considered as a "doomed organ", with pulp extirpitation and root canal treatment being the standard treatment protocol In cases involving pulp exposure to the level of coronal pulp, pulpotomy has emerged as a treatment protocol as it aids in preserving the vitality of the tooth
Preservation of pulpal vitality of of paramount importance as vital functioning of pulp is capable of initiating several important functions such as formation of dentin, providing nutritive support, enabling a defensive function and possessing a unique regenerative capacity
Pulpotomy is a procedure which involves removal of inflammed coronal pulpal tissue and replacing it with a suitable material, leaving vital radicular pulp within the canals
The advent of newer bioactive materials like Mineral Trioxide Aggregate (MTA), Biodentine and bioceramics have significantly increased the prognosis of vital pulp therapy
The aim of this study is to evaluate and compare performance of three different bioactive materials as pulpotomy agents in mature permanent molars |