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CTRI Number  CTRI/2025/11/096963 [Registered on: 06/11/2025] Trial Registered Prospectively
Last Modified On: 05/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Non-randomized, Multiple Arm Trial 
Public Title of Study   Comparing three local dressings to stop bleeding after tooth extraction in adults taking antiplatelet medicines 
Scientific Title of Study   Comparative Evaluation of Hemocoagulase , Chitosan Dental Dressing, Cologenesis collagen plug® After Dental Extractions in Patients Undergoing Antiplatelet Therapy- A prospective clinical study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Jayneel H Raichura 
Designation  Resident  
Affiliation  DeDr D Y Patil Dental College and Hospital 
Address  Department of Oral and Maxillofacial Surgery, Room no 102, Dr D Y Patil Dental College, Sant Tukaram Nagar, Pimpri Colony, Pimpri-Chinchwad, Maharashtra 411018

Pune
MAHARASHTRA
411018
India 
Phone  9619453151  
Fax    
Email  jayhraichura@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  B.M Rudagi 
Designation  Professor and Head of Department 
Affiliation  Dr D Y Patil Dental College and Hospital 
Address  Department of Oral and Maxillofacial Surgery, Room no 102, Dr D Y Patil Dental College, Sant Tukaram Nagar, Pimpri Colony, Pimpri-Chinchwad, Maharashtra 411018

Pune
MAHARASHTRA
411018
India 
Phone  9619453151  
Fax    
Email  bm.rudagi@dpu.edu.in  
 
Details of Contact Person
Public Query  
Name  Jayneel H Raichura 
Designation  Resident  
Affiliation  DeDr D Y Patil Dental College and Hospital 
Address  Department of Oral and Maxillofacial Surgery, Room no 102, Dr D Y Patil Dental College, Sant Tukaram Nagar, Pimpri Colony, Pimpri-Chinchwad, Maharashtra 411018

Pune
MAHARASHTRA
411018
India 
Phone  9619453151  
Fax    
Email  jayhraichura@gmail.com  
 
Source of Monetary or Material Support  
Dr D Y Patil Dental College and Hospital, Pimpri-Chinchwad, Maharashtra, India, 411018  
 
Primary Sponsor  
Name  Jayneel H Raichura 
Address  Sant Tukaram Nagar, Pimpri Colony, Pimpri-Chinchwad, Maharashtra 411018 
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 Jayneel H Raichura   Department of Oral and Maxillofacial Surgery, Dr. D.Y. Patil Dental College and Hospital, Pune  Department of Oral and Maxillofacial Surgery, Room no 102, Dr D Y Patil Dental College, Sant Tukaram Nagar, Pimpri Colony, Pimpri-Chinchwad, Maharashtra 411018
Pune
MAHARASHTRA 		 96194 53151

jayhraichura@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee, Dr. D. Y. Patil Vidyapeeth  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Adults on antiplatelet therapy requiring simple tooth extraction, at risk of post-extraction bleeding 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Chitosan Dental Dressing  Chitosan is a biopolymer derived from chitin with intrinsic positive charge that promotes rapid red blood cell aggregation and platelet adhesion independent of the coagulation cascade; it is mucoadhesive, biocompatible, and has mild antimicrobial properties. A sterile chitosan hemostatic dressing is used immediately after completion of simple tooth extraction; one trimmed piece is placed to line the extraction socket and gently compressed, followed by a firm pressure pack. 
Comparator Agent  Cologenesis® Collagen Plug  Cologenesis Type I collagen acts as a biocompatible scaffold that activates platelets, concentrates clotting factors, and stabilizes the developing fibrin clot while supporting early socket healing; it is absorbable and resorbs over time. An absorbable collagen wound plug is used immediately after completion of simple tooth extraction; one plug is trimmed to the socket size and gently packed to achieve full contact, followed by a firm pressure pack. 
Intervention  Hemocoagulase (topical, intra-alveolar)  Hemocoagulase is a topical hemostatic enzyme used Immediately after completion of simple tooth extraction, approximately 0.5 to 1.0 mL is applied to fully wet the extraction socket using a sterile syringe or applicator, followed by a firm pressure pack 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Age 18 to 70 years

Patients indicated for at least one simple tooth extraction

Patients on stable antiplatelet monotherapy

Patients with INR 1.5 to 3.5 and if are co-prescribed with anticoagulants

 
 
ExclusionCriteria 
Details  Allergy to any study agents

Immunocompromised or diabetic patients

Current infection at extraction site

On anticoagulant or dual antiplatelet therapy

Pregnant/lactating women 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Time to hemostasis  Time to hemostasis Time Points: Day 0 (intra-operative, immediately post-extraction). 
 
Secondary Outcome  
Outcome  TimePoints 
Wound-healing quality  Day 3, Day 7, Day 14 post-extraction 
Postoperative pain  Time Points: Day 3, Day 7, Day 14 post-extraction 
Patient-reported satisfaction with bleeding control and comfort  Time Points: Day 3 and Day 7 post-extraction 
 
Target Sample Size   Total Sample Size="45"
Sample Size from India="45" 
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   Post Marketing Surveillance 
Date of First Enrollment (India)   01/12/2025 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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 - NO
Brief Summary  

This prospective three arm clinical study evaluates the effectiveness of three local hemostatic agents applied after simple tooth extraction in adults receiving antiplatelet therapy. Participants are allocated to one of three interventions hemocoagulase solution or gel, chitosan dental dressing, or collagen plug. The primary purpose is to determine which agent achieves faster control of bleeding and supports better early wound outcomes without increasing complications. The primary outcome is time to hemostasis in minutes measured immediately after extraction. Secondary outcomes include wound healing scores on days 3, 7, and 14, postoperative pain on a visual analogue scale, secondary bleeding events, dry socket, infection, rescue measures, analgesic use, patient satisfaction, and adverse events up to 14 days. Hypothesis: at least one of the three agents will reduce time to hemostasis and improve short term postoperative outcomes compared with the others in patients on antiplatelet therapy.

 
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