| CTRI Number |
CTRI/2023/08/057062 [Registered on: 30/08/2023] Trial Registered Prospectively |
| Last Modified On: |
19/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparision between two different material for coronal pulp removal procedure in primary teeth. |
|
Scientific Title of Study
|
Comparative evaluation of MTA putty with conventional MTA as a Pulpotomy Medicament in Primary Molars: A randomized clinical study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Palak Shah |
| Designation |
PG student |
| Affiliation |
K.M.Shah dental college and hospital |
| Address |
K.M.Shah dental college and hospital,pipariya,waghodiya,vadodara,gujarat
Vadodara GUJARAT 391760 India |
| Phone |
8866308857 |
| Fax |
|
| Email |
palak9249@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DR Pratik kariya |
| Designation |
Professor |
| Affiliation |
K.M.Shah dental college and hospital |
| Address |
K.M.Shah dental college and hospital,pipariya,waghodiya,vadodara,gujarat
Vadodara GUJARAT 391760 India |
| Phone |
9558330199 |
| Fax |
|
| Email |
prateek.kariya@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
DR Pratik kariya |
| Designation |
Professor |
| Affiliation |
K.M.Shah dental college and hospital |
| Address |
K.M.Shah dental college and hospital,pipariya,waghodiya,vadodara,gujarat
Vadodara GUJARAT 391760 India |
| Phone |
9558330199 |
| Fax |
|
| Email |
prateek.kariya@gmail.com |
|
|
Source of Monetary or Material Support
|
| K.M SHAH Dental College and Hospital,Sumandeep Vidyapeeth,Vadodara |
|
|
Primary Sponsor
|
| Name |
Palak shah |
| Address |
K.M.Shah dental college and hospital vadodara |
| 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 |
| Palak shah |
KM SHAH DENTAL COLLEGE AND HOSPITAL |
Department of Pediatric and preventive dentistry room no.3, k.m.shah dental college and hospital,sumandeep vidyapeeth, vadodara Vadodara GUJARAT |
8866308857
palak9249@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sumandeep vidyapeeth institutional ethics committee |
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 |
MTA angelus |
It is conventional MTA with success documented in pulpotomy |
| Intervention |
MTA putty |
It is bioceramic MTA in putty consistency and has ease of application and less wastage.After treatment follow up will be taken at 6 months and 12 month. |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
1. Children aged 4-9 years.
2. Primary molars with deep caries lesion without spontaneous or persistent pain and with physiological resorption of less than oneâ€third of the root.
3. Vital carious pulp exposures that bleed upon entering the pulp chambers and with hemostasis controlled in <5 min.
|
|
| ExclusionCriteria |
| Details |
1.Children with systemic or mental disorders.
2. Teeth eliciting the signs and symptoms of chronic infection such as swelling, mobility, and sinus tract tenderness to percussion.
3. Presence of any radiographic signs that indicate pulp necrosis, such as internal or external root resorption, inter†radicular and/or periradicular bone destruction.
4. Teeth that cannot to be isolated by the rubber dam.
5. Parents who do not give consent for their child to participate in the study
|
|
|
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 |
| Success of pulpotomy relies on medicament used & there are recent advancement in MTA material which is available in putty consistency which has ease of handling & cause less wastage of material. So, at the end of this study we will come to know if e-MTA putty is clinically and radiographically successful as compared to MTA Angelus. |
1 day,6 months,12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Will come to know the best pulpotomy medicament |
1 day,6 months,12 months |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="61" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
11/09/2023 |
| Date of Study Completion (India) |
13/05/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Manuscript preparation in process |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
M. Torabinejad introduced MTA in endodontics in 1993 as a root end filling material. It was given approval by the U.S. Food and Drug Administration in 1998. MTA has several desirable properties such as biocompatibility, hydrophilicity, radiopacity, sealing ability, low solubility and when it comes in contact with fluids forms an apatite like layer on its surface10,11. Investigators have showed that it can conduct and induct hard tissue formation. Studies have showed that when MTA is placed on exposed pulp tissue it causes proliferation, differentiation and migration of odontoblast like cells, which produce a collagen matrix. The collagen matrix is then mineralized and produces osteodentine initially and few weeks to month’s later tertiary dentinal bridge formation occurs and studies conclude that MTA is a material of choice and can replace Ca (OH)2 for a better outcome of pulpotomy procedures . MTA Angelus (Angelus, Londrina, Brazil /Clinician‘s Choice, New Milford, CT) was launched in Brazil in 2001 and received FDA approval in 2011. It is mixed with water at 3:1 powder: liquid ratio. It’s initial setting time is 15 minutes and compressive strength is 34 MPa . The pH of MTA is 10.2 after mixing which rises to 12.5 after 3 hours but there are drawbacks of MTA which have been documented it includes discoloration potential of MTA, difficult handling characteristics, high material cost, technique sensitive and contain heavy metals like aluminium oxide, bismuth oxide and produce a considerably waste. So, new calcium silicate-based material with improved properties were introduced. Powder /liquid systems require manual mixing. Therefore, premixed bioceramics were introduced. The premixed sealer, paste, and putty have the advantage of uniform consistency and no wastage. These premixed bioceramics are all hydrophilic and require moisture from the surrounding tissues to set . This putty is delivered through a syringe and thus does not require hand mixing. The syringe also gives the clinician the ability to dispense the exact amount of material needed for the procedure and thus reduces waste. Unlike regular MTA, it does not cause discoloration of remaining tooth structure. It is dimensionally stable, with zero shrinkage and minimal expansion, and has a very high radiopacity. Kids-e-Dental’s e-MTA putty is a pre-mixed bio-ceramic, insoluble, radiopaque and bioactive paste consisting of very fine hydrophilic particles of several mineral oxides. Its composition includes tricalcium silicate, dicalcium silicate, tricalcium aluminate and zirconium oxide. It is handy and easy to use, has non sticky consistency, washout resistance and non-staining and no heavy metals. |