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CTRI Number  CTRI/2025/02/081221 [Registered on: 24/02/2025] Trial Registered Prospectively
Last Modified On: 24/02/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Evaluation of proteolytic enzymes in managing postendodontic pain 
Scientific Title of Study   Comparative evaluation of effect of two different proteolytic enzyme on severity of post-operative pain after a single visit endodontic treatment assessed over three days – randomized control trial 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Darshan Turkhade 
Designation  Third MDS 
Affiliation  Dr Hedgewar Dental College & Hospital 
Address  Department of Conservative Dentistry and Endodontics Dr Hedgewar Smruti Rugna Seva Mandals Dental College and Hospital Basamba Phata Akola Road Hingoli Maharashtra 431513

Hingoli
MAHARASHTRA
431513
India 
Phone  8698495882  
Fax    
Email  midarshanturkhade@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rajiv Khode 
Designation  Associate Proffesor & Guide 
Affiliation  Dr Hedgewar Dental College & Hospital 
Address  Department of Conservative Dentistry and Endodontics Dr Hedgewar Smruti Rugna Seva Mandals Dental College and Hospital Basamba Phata Akola Road Hingoli Maharashtra 431513

Hingoli
MAHARASHTRA
431513
India 
Phone  8208899410  
Fax    
Email  rajiv.khode@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Rajiv Khode 
Designation  Associate Proffesor & Guide 
Affiliation  Dr Hedgewar Dental College & Hospital 
Address  Department of Conservative Dentistry and Endodontics Dr Hedgewar Smruti Rugna Seva Mandals Dental College and Hospital Basamba Phata Akola Road Hingoli Maharashtra 431513

Hingoli
MAHARASHTRA
431513
India 
Phone  8208899410  
Fax    
Email  rajiv.khode@gmail.com  
 
Source of Monetary or Material Support  
Dr hedgewar smruti rugna seva mandals dental college and hospital 431513 Hingoli Maharashtra India 
 
Primary Sponsor  
Name  Dr darshan turkhade 
Address  Dr hedgewar smruti rugna seva mandals dental college basamba phata hingoli 431513 Maharashtra India 
Type of Sponsor  Research institution and hospital 
 
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 darshan turkhade  Dr. Hedgewar Smruti Rugna Sewa Mandals Dental College And Hospital, Hingoli 431513 Maharashtra India  Department Of Conservative Dentistry And Endodontics, Dr.HSRSM Dental College And Hospital, Hingoli, 431513 Maharashtra, India
Hingoli
MAHARASHTRA 		 8698495882

midarshanturkhade@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Dr HSRSM dental college institutional ethical comittee  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  Ibuprofen  Type of NSAID, 400 mg thrice a day given for 3 days 
Intervention  Serratiopeptidase  Type of proteolytic enzyme,10 mg thrice a day given for 3 days 
Intervention  Trypsin chymotrypsin complex   chymorol forte type of proteolytic enzyme, 5 mg thrice a day given for 3 days  
 
Inclusion Criteria  
Age From  14.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  mandibular first molar teeth and showing no radiographic evidence of periapical or periodontal pathosis.
healthy crown structure and good prognosis. 
 
ExclusionCriteria 
Details  pregnant females.
teeth with bad prognosis.
patients who have taken analgesics 24 hrs prior to treatment. 
 
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 and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate and compare effect of two different proteolytic enzyme on severity of post-operative pain after a single visit endodontic treatment assessed over three days.  3 days 
 
Secondary Outcome     
Target Sample Size   Total Sample Size="39"
Sample Size from India="39" 
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)   27/03/2025 
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="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
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 - Informed Consent Form
    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 - For individual participant data meta-analysis.

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

  6. For how long will this data be available start date provided 01-05-2025 and end date provided 01-05-2035?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NA
Brief Summary    This study is randomized control trial evaluating effect of two different proteolytic enzyme on severity of post-operative pain after a single visit endodontic treatment assessed over three days that will be conducted in Dr HSRSM dental college hingoli, india.  
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