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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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 one‐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.

 
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