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CTRI Number  CTRI/2018/02/011672 [Registered on: 02/02/2018] Trial Registered Retrospectively
Last Modified On: 26/01/2018
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Other 
Public Title of Study   Comparative Clinical Evaluation of the Efficacy of Local Application of Ayapon Tablets Vs Sepgard Gel to Arrest Bleeding in Intraoral Open Wounds. 
Scientific Title of Study   Comparative Clinical Evaluation of the Efficacy of Local Application of AyaponTM Tablets Vs SepgardTM Gel to Arrest Bleeding in Intraoral Open Wounds. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Abhishek singh 
Designation  2nd year postgraduate student 
Affiliation  Nair Hospital Dental College 
Address  202,Department of periodontics,Nair hospital dental college,mumbai-08

Mumbai (Suburban)
MAHARASHTRA
400067
India 
Phone  9870611172  
Fax    
Email  abhisingh3005@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Mala dixit baburaj 
Designation  Professor and Head of Department 
Affiliation  Nair Hospital Dental College 
Address  202,Department of periodontics,Nair hospital dental college,mumbai-08

Mumbai (Suburban)
MAHARASHTRA
400067
India 
Phone  9223340938  
Fax    
Email  maladixit25@gmail.com  
 
Details of Contact Person
Public Query  
Name  Abhishek singh 
Designation  2nd year postgraduate student 
Affiliation  Nair Hospital Dental College 
Address  202,Department of periodontics,Nair hospital dental college,mumbai-08

Mumbai (Suburban)
MAHARASHTRA
400067
India 
Phone  9870611172  
Fax    
Email  abhisingh3005@gmail.com  
 
Source of Monetary or Material Support  
Nair Hospital Dental College 
 
Primary Sponsor  
Name  Abhishek Singh 
Address  A/503,Neelam Apartment,Sector-5,Charkop,Kandivali-west,Mumbai-67 
Type of Sponsor  Other [] 
 
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 
Abhishek singh  Nair hospital dental college  Room No 202,Department of Periodontics,Nair Hospital Dental College,Mumbai central-08
Mumbai
MAHARASHTRA 		 9870611172

abhisingh3005@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee - Nair Hospital Dental College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Patients undergoing any form of intraoral periodontal surgical therapy will be selected with similar bleeding parameters,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Ayapon tablet  Commercially available natural product like Ayapon tablet 
Comparator Agent  Sepgard gel   Commercially available synthetic product like Sepgard gel 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1.Age group between 20-45years.
2.Patients in good systemic health.
3.Patients undergoing any form of intraoral periodontal surgical therapy will be selected with similar bleeding parameters. 
 
ExclusionCriteria 
Details  1.Patients suffering from any systemic diseases or with compromised immune system.
2.Patients with a known history of drug allergy
3.Patients taking any drug known to cause gingival enlargement
4.Patients taking any immuno-suppressive drugs like corticosteroids.
5.Pregnant and/or lactating mothers.
6.Patients with any bleeding disorders.
7.Patient on anticoagulant therapy.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1)Bleeding test assessment.
2)Clotting time assessment.
 		 During the Surgery bleeding time and clotting time will be assessed with the help of an automated timer 
 
Secondary Outcome  
Outcome  TimePoints 
During the surgery local application of Ayapon tablet and Sepgard gel has to be done to arrest bleeding.  The patients will be recalled at 7th day,30th day,45th day post surgery to assess any untoward effect of these products on the recipient site. 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" 
Phase of Trial   N/A 
Date of First Enrollment (India)   06/03/2017 
Date of Study Completion (India) 10/10/2017 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None Yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   The aim of this study is to clinically compare a natural product like Ayapon tablet & a Synthetic product like Sepgard gel as an adjunct to arrest bleeding to resolve inflammation thereby promote faster healing. A total of 40 patients will be selected for this study from outpatient department of Periodontics, Nair Hospital Dental College, Mumbai. Audio video consent will be taken prior to the study and if the patient is willing to discontinue the treatment procedure during the study, he or she will be allowed to do so. In Group A Bleeding is arrested with local application of AyaponTM tablet while in Group B Bleeding is arrested with application of SepgardTM gel. Computer generated randomization method will be used as sampling method. The duration of the study is 6 months. The primary efficacy parameters are bleeding and clotting time assessment. During the surgery local application of Ayapon tablet and Sepgard gel has to be done to arrest bleeding.The patients will be recalled at 7th day,30th day,45th day post surgery to assess any untoward effect of these products on the recipient site. The data will be analysed individually for all the patients. The values will be subjected comparison betweeen groups using unpaired student t-test. There is no conflict of interest. 
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