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CTRI Number  CTRI/2017/01/007719 [Registered on: 17/01/2017] Trial Registered Retrospectively
Last Modified On: 16/01/2017
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia
Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of two different dressings on palatal wound healing 
Scientific Title of Study   Comparative evaluation of the efficacy of a commercially available collagen dressing (Collacote®) with autologous Platelet Rich Fibrin (PRF) membrane on the wound healing of palatal donor site of free gingival graft 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Varsha Sharma 
Designation  Ex Post Graduate Student 
Affiliation  Institute of Dental Studies and Technologies 
Address  Department of Periodontology, Institute of Dental Studies and Technologies, NH-58, Delhi-Meerut Road, Kadrabad, Modinagar

Ghaziabad
UTTAR PRADESH
201201
India 
Phone  08126021212  
Fax    
Email  drsharmavarsha@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ashish Kumar 
Designation  Professor 
Affiliation  Institute of Dental Studies and Technologies 
Address  Department of Periodontology, Institute of Dental Studies and Technologies, NH-58, Delhi-Meerut Road, Kadrabad, Modinagar

Ghaziabad
UTTAR PRADESH
201201
India 
Phone  09999813132  
Fax    
Email  ashishkumar97@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Komal Puri 
Designation  Reader 
Affiliation  Institute of Dental Studies and Technologies 
Address  Department of Periodontology, Institute of Dental Studies and Technologies, NH-58, Delhi-Meerut Road, Kadrabad, Modinagar

Ghaziabad
UTTAR PRADESH
201201
India 
Phone  09818190603  
Fax    
Email  komal_arora09@yahoo.co.in  
 
Source of Monetary or Material Support  
Self sponsored 
 
Primary Sponsor  
Name  Institute of Dental Studies and Technologies  
Address  Institute of Dental Studies and Technologies, NH-58, Delhi-Meerut Road, Kadrabad, Modinagar, Uttar Pradesh, India-201201  
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
None   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Varsha Sharma  Institute of Dental Studies and Technologies   Department of Periodontology, Room number 7, Institute of Dental Studies and Technologies, Modinagar
Ghaziabad
UTTAR PRADESH 		 08126021212

drsharmavarsha@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethical Committee of Institute of Dental Studies and Technologies  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Patients requiring free gingival graft for increasing width of attached gingiva or recession coverage,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Collacote®  CollaCote® dressings are claimed to control bleeding and stabilize blood clots as well as protect the wound while accelerating the healing process. Commercially available collagen dressing of size 15X15 mm or 18X12.5 mm both having an area of 225 square mm was sutured on the palatal wound once during the entire period of healing 
Intervention  Platelet rich fibrin membrane  Platelet rich fibrin is an autologous membrane and is a platelet concentrate that contains all the constituents of a blood sample which are favourable for healing. Prepared membrane of size 15X15 mm or 18X12.5 mm both having an area of 225 square mm was sutured on the palatal wound once during the entire period of healing 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  52.00 Year(s)
Gender  Both 
Details  1)Systemically healthy patients aged 18 years or more,
2)Patient not under any medication for the past six months,
3)Patients requiring FGG either for reduced/ inadequate gingiva or gingival recession in the maxillary or mandibular anterior region,
4)Patients who have not undergone any palatal graft procedure in the past one year.
 
 
ExclusionCriteria 
Details  1)Smokers,
2)Pregnant or lactating mothers,
3)Patients not maintaining oral hygiene. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Immediate Bleeding
Delayed Bleeding
Pain Score
Size of wound
Depth of wound
Toluidine blue test for epithelization
Hydrogen peroxide test for epithelization 		 Immediate Bleeding:After suturing the donor area
Delayed Bleeding: Between 1st – 7th Post operative days
Pain Score, size, Toluidine blue test: 7th ,12th, 18th, 24th and 30th post-operative day.
Depth of wound: Before surgery, immediately post surgery, post application of dressing and on 12th, 24th and 30th post-operative days.
Hydrogen peroxide test for epithelialization: 7th & 8th, 12th &13th, 18th &19th, 24th &25th, 30th & 31st post-operative day.
 
 
Secondary Outcome  
Outcome  TimePoints 
None  None 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   N/A 
Date of First Enrollment (India)   05/05/2014 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not published 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

This study was conducted and compiled by Dr.Varsha Sharma, Dr.Ashish Kumar, Dr.Komal Puri, Dr.Mansi Bansal and Dr.Manish Khatri at Department Of Periodontology, Institute of Dental Studies and Technologies, Kadrabad, Modinagar, Uttar Pradesh, India

The study is a randomized control trial for comparison of the effect of commercially available collagen dressing (colla cote®) and autologous platelet rich fibrin on the wound healing of palatal donor site of free gingival graft.  Assessment and comparison of various wound healing parameters, time required for complete epithelization of wound and considerable morbidity during the healing period was done.

 
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