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CTRI Number  CTRI/2022/07/044184 [Registered on: 20/07/2022] Trial Registered Prospectively
Last Modified On: 19/07/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparative evaluation of three cements in healing the pulp in lower molars of milk teeth in children  
Scientific Title of Study   Comparative evaluation of MTA, Biodentine and a new calcium silicate material as Pulpotomy agents in primary molars- A pilot study  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Nikitha Suzanne Varghese 
Designation  Pg student  
Affiliation  Saveetha Dental College 
Address  162, Poonamallee High Rd, Velappanchavadi, Chennai, Tamil Nadu 600077

Thiruvallur
TAMIL NADU
600077
India 
Phone  7708528075  
Fax    
Email  nikitha.varghese@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Nikitha Suzanne Varghese 
Designation  Pg student  
Affiliation  Saveetha Dental College 
Address  162, Poonamallee High Rd, Velappanchavadi, Chennai, Tamil Nadu 600077

Thiruvallur
TAMIL NADU
600077
India 
Phone  7708528075  
Fax    
Email  nikitha.varghese@gmail.com  
 
Details of Contact Person
Public Query
 
Name  EMG Subramanian 
Designation  Professor and HOD of Department of Pedodontics, Saveetha Dental College 
Affiliation   
Address  Clinic 28 Head of the Department Department of a Pedodontics Saveetha dental college 162, Poonamallee High Rd, Velappanchavadi, Chennai, Tamil Nadu 600077

Thiruvallur
TAMIL NADU
600077
India 
Phone    
Fax    
Email  emg.subu@gmail.com  
 
Source of Monetary or Material Support  
Saveetha Dental College and Hospital 
 
Primary Sponsor  
Name  Nil 
Address  Nil 
Type of Sponsor  Other [Self sponsor] 
 
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 
Dr Nikitha  Saveetha Dental College  Clinic 28, Department of Pedodontics 162, Saveetha dental college Poonamallee high road
Thiruvallur
TAMIL NADU 
07708528075

drnikitha.varghese@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SIMATS  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  Biodentine  Tricalcium silicate cement manufactured by Septodont for one year 
Comparator Agent  MTA Angelus  Repairative cement composed of Tricalium silicate and manufactured by Angelus for one year 
Intervention  New Calcium silicate Material  Composed of mainly Tricalcium silicate and calcium chloride. Produced by the investigator. For one year 
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  13.00 Year(s)
Gender  Both 
Details  Children of 4-13 years of age
Pulp exposure due to caries or after traumatic pulp exposure
No history of spontaneous pain, tooth mobility
No clinical evidence of pulpal inflammation or degeneration
Restorable teeth
Absence of radiographic evidence of internal or external resorption, pulpal calcification
 
 
ExclusionCriteria 
Details  children with special needs
Pain
mobility 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Clinical and Radiographic success
(No pain or swelling) 
1 month, 3 months, 1 year 
 
Secondary Outcome  
Outcome  TimePoints 
Dentine bridge formation  1 year 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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   N/A 
Date of First Enrollment (India)   31/08/2022 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [drnikitha.varghese@gmail.com].

  6. For how long will this data be available start date provided 30-06-2022 and end date provided 25-06-2024?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   Child from the ages of 4to9 years who visit the Department of Preventive and Paediatric dentistry, Saveetha dental college will be a apart of the trial after given consent. 
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