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CTRI Number  CTRI/2020/03/023894 [Registered on: 11/03/2020] Trial Registered Prospectively
Last Modified On: 23/12/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To evaluate and compare postoperative pain and success rate of pulpotomy with Biodentine using diode laser and normal saline in mature cariously exposed permanent molars and premolars. 
Scientific Title of Study   Comparative Evaluation of Pulpotomy with Biodentine using Diode Laser and Normal Saline in Cariously Exposed Permanent molars and premolars: A Randomized Controlled Trial with One Year Follow Up 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shipra Jain 
Designation  Post Graduate Student 
Affiliation  SGT Dental college,Gurugram  
Address  Department of Conservative Dentistry and Endodontics, Faculty of Dental Sciences, SGT University,Budhera,Gurugram

Gurgaon
HARYANA
122006
India 
Phone  9899153961  
Fax    
Email  shipujain905@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ashtha arya 
Designation  Professor  
Affiliation  SGT Dental college,Gurugram  
Address  Department of Conservative Dentistry and Endodontics, Faculty of Dental Sciences, SGT University,Budhera,Gurugram

South West
DELHI
122505
India 
Phone  9810761757  
Fax    
Email  drashthaarya@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Shipra Jain 
Designation  Post Graduate Student 
Affiliation  SGT Dental college,Gurugram  
Address  Department of Conservative Dentistry and Endodontics, Faculty of Dental Sciences, SGT University,Budhera,Gurugram

Gurgaon
HARYANA
122006
India 
Phone  9899153961  
Fax    
Email  shipujain905@gmail.com  
 
Source of Monetary or Material Support  
Dr. shipra jain SGT dental college and research institute Gurugram ,Haryana 
 
Primary Sponsor  
Name  Dr Shipra Jain 
Address  Department of Conservative Dentistry and Endodontics 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 
Dr Shipra Jain  Sgt Dental College  Department of Conservative Dentistry and Endodontics, Faculty of Dental Sciences, SGT University,Budhera,Gurugram
Gurgaon
HARYANA 		 9899153961

shipujain905@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Dr. Ritu duggal, Dr. Mandeep S Grewal, Dr. Anil Gupta, Dr. Poonam salwan, Mr. Sachinder chauhan, Mr. Azad singh, Mr. dinesh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Periodontally healthy human permanent teeth with the carious exposure of pulp having positive response to sensibility tests and a history of pain, sensitivity and presenting symptoms characteristic of symptomatic irreversible pulpitis according to AAE,in the absence of sinus tract or swelling.  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  nil  nil 
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  69.00 Year(s)
Gender  Both 
Details  1.Periodontally healthy human maxillary and mandibular permanent molars and premolars with the carious exposure of pulp.
2.Age criteria- patients ranging from 18 to 69 years of age.
3.Positive response to sensibility tests and a history of pain, sensitivity and presenting symptoms characteristic of symptomatic irreversible pulpitis according to American Association of Endodontics diagnosis terminology, in the absence of sinus tract or swelling.
 
 
ExclusionCriteria 
Details  1.Immunocompromised patients.
2.Patients having negative response to vitality tests.
3.Positive history of intake of antibiotics use in the past one month or requiring antibiotic prophylaxis.
4.Tooth previously accessed.
5.Association of periapical lesion visible on the radiograph.
6.Cases in which the bleeding could not be controlled up to eight minutes (in pulpotomy cases only).
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Patients will be recalled at 3 months, 6 months and 12 months for clinical and radiographic examination and evaluation of functionality of the tooth and integrity of the restoration, to check for presence of any cracks or fractures in the tooth, discoloration of the tooth.  Patients will be recalled at 3 months, 6 months and 12 months 
 
Secondary Outcome  
Outcome  TimePoints 
pain and sensitivity will be scored preoperatively at 24 hours, 48 hours and the seventh day and fourteenth day after the first appointment day on 170 mm HP VAS.  pain and sensitivity will be scored preoperatively at 24 hours, 48 hours and the seventh day and fourteenth day after the first appointment day on 170 mm HP VAS. 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="150" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/03/2020 
Date of Study Completion (India) 12/10/2021 
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)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   The purpose of the study is to evaluate and compare the clinical and radiographic responses of the pulp-dentin complex after capping the radicular pulp with a new tricalcium based cement biodentine in human permanent molars and premolars using diode laser and normal saline. 150 subjects having positive response to pulp sensibility test and presenting symptoms of irreversible pulpitis in absence of any sinus tract or fistula will be randomly divided in to 3 groups of 50 subjects each. In 2 groups, Pulpotomy with biodentine will be performed using diode laser and normal saline and group 3 is the control group in which root canal treatment will be performed. Follow up will be done at 3 months,6 months and 12 months for clinical and radiographic evaluation. 
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