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CTRI Number  CTRI/2020/03/023766 [Registered on: 04/03/2020] Trial Registered Prospectively
Last Modified On: 03/03/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of pulpotomy in teeth using MTA and biodentine 
Scientific Title of Study   Comparitive Evaluation Of Post Operative Pain And Success Rate Of MTA Pulpotomy And Biodentine Pulpotomy And Root Canal Treatment In Cariously Exposed Permanent Molars And Premolars: An In Vivo Study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mahak Mitra 
Designation  Post graduate student, Conservative and Endodontics 
Affiliation  Faculty of dental sciences, Sgt University, budhera, gurugram 
Address  Faculty of dental sciences, Sgt University, Budhera, Gurugram

Gurgaon
HARYANA
122006
India 
Phone  8826827933  
Fax    
Email  mahakmitra.03@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Mandeep S Grewal 
Designation  Head of the Department, Conservative and Endodontics 
Affiliation  Faculty of Dental Sciences, Sgt University, Budhera, Gurugram 
Address  Faculty of Dental Sciences, Sgt University, Budhera, Gurugram

Gurgaon
HARYANA
122006
India 
Phone  8826827933  
Fax    
Email  drmandeepsgrewal@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Mahak Mitra 
Designation  Post Graduate student, Conservative and Endodontics 
Affiliation  Faculty of Dental Sciences, Sgt University, Budhera, Gurugram 
Address  Faculty of Dental Sciences, Sgt University, Budhera, Gurugram

Gurgaon
HARYANA
122006
India 
Phone  8826827933  
Fax    
Email  mahakmitra.03@gmail.com  
 
Source of Monetary or Material Support  
Department of Conservative and Endodontics,Faculty of Dental Sciences, Sgt Dental College, Budhera, Gurugram 
 
Primary Sponsor  
Name  Mandeep S Grewal 
Address  Faculty of Dental Sciences, Sgt University, Budhera, Gurugram 
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 
Mahak Mitra  Faculty of Dental Sciences, Sgt University  Department of Conservative and Endodontics
Gurgaon
HARYANA 		 8826827933

mahakmitra.03@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institutional review board ethical committee, faculty of dental sciences, sgt university, budhera  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  cariously exposed permanent molars and premolars with clinical features of chronic irriversible pulpitis 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Biodentine And MTA  Bioactive Agents used for pulpotomy 
Intervention  Root Canal Therapy  Root Canal Therapy to be initiated if clinical signs and symptoms of failure of treatment 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  69.00 Year(s)
Gender  Both 
Details  1. Periodontally healthy maxillary and mandibuar permanent molars and premolars with the carious exposure of pulp will be included.
2. Age criteria- patients ranging from 18 to 69 years of age will be incuded in the study.
3. Positive response to vitality tests and a history of pain and presenting symptoms characteristic of symptomatic irreversible pulpitis according to American Association of Endodontics diagnosis terminology, but in the absence of sinus tract or swelling will be included.
 
 
ExclusionCriteria 
Details  •Immunocompromised patients
•Patients having negative response to vitality tests
•Positive history of intake of antibiotics use in the past one month or requiring antibiotic prophylaxis.
•Tooth previously accessed.
•Association of periapical lesion visible on the radiograph.
•Cases in which the bleeding could not be controlled upto fifteen minutes.

 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Centralized 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
No post operative pain and successful treatment outcome  1 year 
 
Secondary Outcome  
Outcome  TimePoints 
Pain or swelling at follow up visits  1 year, 6 months 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
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)   05/03/2020 
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="5" 
Recruitment Status of Trial (Global)   Not Applicable 
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)?  

Brief Summary   cariously exposed mature premolar and molar teeth with irreversible pulpitis were allocated in three groups. in the first group pulpotomy was done using MTA, in the second group pulpotomy was done using biodentine and in the third group root canal treatment was performed and the patients were recalled at subsequent follow up visits for evaluating the post operative pain and success rate of pulpotomy as compared to root canal therapy. groups in which pulpotomy was performed, if reported with pain then root canal therapy was initiated for those patients. 
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