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CTRI Number  CTRI/2022/07/044481 [Registered on: 29/07/2022] Trial Registered Prospectively
Last Modified On: 28/04/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   to check the success rate of vital pulp therapy in mature permanent teeth  
Scientific Title of Study   A COMPARATIVE EVALUATION OF VARIOUS BIO-MATERIALS AS PULPOTOMY AGENTS IN MATURE PERMANENT MOLARS WITH IRREVERSIBLE PULPITIS- 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  Dr Tarun Kumar 
Designation  Professor  
Affiliation  Dasmesh Institute of Research and Dental Sciences 
Address  Dasmesh Institute of Research and Dental Sciences talwandi road Faridkot
Talwandi road faridkot
Faridkot
PUNJAB
151203
India 
Phone  9888666699  
Fax    
Email  drtarunkumar@hotmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Tarun Kumar 
Designation  Professor  
Affiliation  Dasmesh Institute of Research and Dental Sciences 
Address  Dasmesh Institute of Research and Dental Sciences talwandi road Faridkot
Talwandi road faridkot

PUNJAB
151203
India 
Phone  9888666699  
Fax    
Email  drtarunkumar@hotmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Tarun Kumar 
Designation  Professor  
Affiliation  Dasmesh Institute of Research and Dental Sciences 
Address  Dasmesh Institute of Research and Dental Sciences talwandi road Faridkot
Talwandi road faridkot

PUNJAB
151203
India 
Phone  9888666699  
Fax    
Email  drtarunkumar@hotmail.com  
 
Source of Monetary or Material Support  
dasmesh institute of research and dental sciences, talwandi road, faridkot, punjab - 151203 
 
Primary Sponsor  
Name  Self 
Address  dasmesh institute of research and dental sciences, talwandi road, faridkot, punjab- 151203 
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 tarun kumar  department of conservative dentistry and endodontics  dasmesh institute of research and dental sciences, faridkot
Faridkot
PUNJAB 		 9888666699

drtarunkumar@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Review Board  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  bio-c Repair material (ANGELUS)  Bio-C repair (angelus) is a bio ceramic material. for this trial we will be checking its efficacy as a pulpotomy agent 
Comparator Agent  biodentine (SEPTODONT)  Biodentine is tricalcium silicate based dentin substitute material. For this specific trial we will be using it to see its efficacy as pulpotomy agent. 
Comparator Agent  endosequence (BRASSELER,USA)  Endosequence (brasseler, USA) is also a calcium silicate based material. for this trial we will be checking its efficacy as pulpotomy agent 
Comparator Agent  mineral trioxide aggregate  MTA is calcium silicate based bio material used for various dental repair treatments. For this specific trial we will be using it to see its efficacy as pulpotomy agent. 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patient age should be between 15-60 with no
contributory medical history.
Deep caries with subsequent pulp exposure in
a permanent molar tooth.
The tooth should respond to pulp vitality
tests.
Pulp tissue bleeding should be present in all
canals after entering the chamber.
Teeth with symptomatic irreversible pulpitis
without periapical involvement.
Tooth should be restorable .
Hemostasis should be achieved after
complete pulpotomy.
 
 
ExclusionCriteria 
Details  Deciduous teeth.
Teeth with deformities, cracks, fractures and
restorations, active disease, moderate/severe
periodontal disease, root resorption, root canal
calcification.
Teeth associated with abscess or sinus
formation.
Pregnant or breast feeding woman.
Immuno-compromised or any active systemic
disease
 
 
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 
• The aim of this study will be to evaluate the success of pulpotomy in mature permanent molars with irreversible pulpitis using different bio-materials based on clinical and radiographical analysis.  in the time frame of 6 months (after the pulpotomy) this study will evaluate the success of pulpotomy in mature permanent molars with irreversible pulpitis using different bio-materials based on clinical and radiographical analysis. 
 
Secondary Outcome  
Outcome  TimePoints 
to Assess the effectiveness of each bio-material as pulpotomy agents.  To compare the success rate of different bio-materials (Mineral Trioxide Aggregate, Biodentin, EndoSequence root repair material, Bio-C repair putty material) used as pulpotomy agents. 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   01/08/2022 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   not submitted for publication 
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 - All of the individual participant data collected during the trial, after de-identification.

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

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - Any purpose.

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

  6. For how long will this data be available start date provided 15-07-2022 and end date provided 15-12-2023?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  

The purpose of this in-vivo study will be to compare the various bio-materials as pulpotomy agents in mature permanent molars with irreversible pulpitis.

●             Adequate number of patients will be selected by following the proper inclusion and exclusion criteria.

●             After the tooth has been properly diagnosed and tested to fall under inclusion criteria, an informed consent will be obtained from the patient.

●             After giving local anesthesia, tooth will be isolated using rubber dam.

●             Using sterile round bur in high speed air-rotor hand piece along with copious irrigation, caries will be removed and pre-endodontic build up will be done, followed by an access cavity.

●             The coronal pulp will be removed till the level of orifices using sterile sharp spoon excavator and copious irrigation with saline.

●             Bleeding will be controlled using 5% sodium hypochlorite on a cotton pellet.

●             After the haemostasis, the pulp chamber will be filled with allocated material, followed by temporary restoration.

●             First baseline follow-up will be done after 24 hours, followed second follow-up after 7 days.

●             After 2 weeks, if the symptomatic improvement is seen, the temporary restoration will be replaced by post-endodontic restoration.

●             The follow-up of the patient will also be done after 3 months, 6 months and 12 months, noting down the clinical symptoms and the radiographic changes.

●             The results obtained will be compared and subjected to statistical analysis.

 

 
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