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CTRI Number  CTRI/2024/03/064205 [Registered on: 15/03/2024] Trial Registered Prospectively
Last Modified On: 11/06/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia
Dentistry 
Study Design  Other 
Public Title of Study   Type of healing bandage 
Scientific Title of Study   Comparative evaluation of Platelet rich fibrin vs Collagen as bandage in palatal donor site: A randomised clinical study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  MANISH RATHI 
Designation  Asst Professor 
Affiliation  Army Dental Corps 
Address  Dept of Periodontology Military dental centre first floor c/o Military Hospital NDA KHADAKWASLA

Pune
MAHARASHTRA
411023
India 
Phone  919971238331  
Fax    
Email  mnshrathi5@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  MANISH RATHI 
Designation  Asst Professor 
Affiliation  Army Dental Corps 
Address  Dept of Periodontology Military dental centre first floor c/o Military Hospital NDA KHADAKWASLA

Pune
MAHARASHTRA
411023
India 
Phone  919971238331  
Fax    
Email  mnshrathi5@gmail.com  
 
Details of Contact Person
Public Query  
Name  MANISH RATHI 
Designation  Asst Professor 
Affiliation  Army Dental Corps 
Address  Dept of Periodontology Military dental centre first floor c/o Military Hospital NDA KHADAKWASLA

Pune
MAHARASHTRA
411023
India 
Phone  919971238331  
Fax    
Email  mnshrathi5@gmail.com  
 
Source of Monetary or Material Support  
Dept of Periodontology Military dental centre first floor c/o Military Hospital NDA KHADAKWASLA 
 
Primary Sponsor  
Name  Manish Rathi 
Address  Dept of Periodontology Military dental centre first floor c/o Military Hospital NDA KHADAKWASLA 
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 
MANISH RATHI  Military Dental Centre Khadakwasla  Dept of Periodontology First floor, c/o Military Hospital NDA KHADAKWASLA Pune-411023
Pune
MAHARASHTRA 		 9971238331

mnshrathi5@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
MDC KHADAKWASLA  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K060||Gingival recession,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Collagen Dressing  Collagen dressing to be used as bandage for healing of the donor site in palatal region 
Intervention  PLatelet rich fibrin(PRF)  PRF is prepared after harvesting small volume of blood from the patient which is prepared by centrifuging blood for 10 minutes 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  both gender
age : 20-50 years
multiple marginal tissue recession requiring soft tissue augmentation procedures

 
 
ExclusionCriteria 
Details  1. Immunocompromised individual
2. Previous irradiation treatment in head and neck area
3. H/o periodontal disease (active)
4. H/o bone metabolic disorders
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
wound healing in donor site
oral health related quality of life(OHQoL) 		 10 days- OHQoL
28 days- wound healing assessment 
 
Secondary Outcome  
Outcome  TimePoints 
Pain perception for 2 different procedures usinf Visual Analog Scale  10 days 
 
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)   24/03/2024 
Date of Study Completion (India) 11/06/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 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 - Informed Consent Form

  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 [mnshrathi5@gmail.coM].

  6. For how long will this data be available start date provided 07-03-2024 and end date provided 31-12-2030?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
Patient requiring multiple marginal tissue recession coverage procedure using connective tissue graft(CTG) harvested from palatal region. Thereafter the palatal wound/donor site will be packed with collagen sponge in Site A and PRF dressing in Site B

Donor sites will equally covered by collagen sponge dressing and Choukroun’s PRF membrane bandage and secured by 4�’0 PTFE sutures. Oral hygiene instructions for 7 days and analgesic SOS will be advised with clear instructions to record the number of analgesics consumed, intensity, nature, and duration of pain.
 
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