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CTRI Number  CTRI/2020/04/024717 [Registered on: 17/04/2020] Trial Registered Prospectively
Last Modified On: 13/04/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Applying marigold plant material on the open wound after removal of a small part of the gums in the mouth and comparing its healing with that of patients own blood material. -As a medical trial. 
Scientific Title of Study   Comparative evaluation of wound healing capacity of Calendula Officinalis with that of platelet rich fibrin (PRF) at the palatal donor site after obtaining free gingival graft. -A Randomized clinical trial.  
Trial Acronym  CPRF 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR BHARATH KUMAR AM 
Designation  Post Graduate Student  
Affiliation  Manipal College of Dental Sciences Manipal 
Address  ROOM NO 3 DEPARTMENT OF PERIODONTOLOGY MANIPAL COLLEGE OF DENTAL SCIENCE MANIPAL ACADEMY OF HIGHER EDUCATION MANIPAL

Udupi
KARNATAKA
576104
India 
Phone  8746842802  
Fax    
Email  dr.bharathkumar1995@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR SANTHOSH KUMAR 
Designation  ASSOCIATE PROFESSOR  
Affiliation  Manipal College of Dental Sciences, Manipal 
Address  ROOM NO 3 DEPARTMENT OF PERIODONTOLOGY MANIPAL COLLEGE OF DENTAL SCIENCE MANIPAL ACADEMY OF HIGHER EDUCATION MANIPAL

Udupi
KARNATAKA
576104
India 
Phone  9741968550  
Fax    
Email  santhosh.kumar@manipal.edu  
 
Details of Contact Person
Public Query  
Name  DR MADHURYA N KEDLAYA  
Designation  ASSISTANT PROFESSOR 
Affiliation  Manipal College of Dental Sciences Manipal 
Address  ROOM NO 3 DEPARTMENT OF PERIODONTOLOGY MANIPAL COLLEGE OF DENTAL SCIENCE MANIPAL ACADEMY OF HIGHER EDUCATION MANIPAL

Udupi
KARNATAKA
576104
India 
Phone  9886487268  
Fax    
Email  madhurya.kedlaya@manipal.edu  
 
Source of Monetary or Material Support  
DR Bharath Kumar A.M Department of Periodontology Manipal College Of dental sciences Manipal  
 
Primary Sponsor  
Name  DR BHARATH KUMAR A M 
Address  ROOM NO 3 DEPARTMENT OF PERIODONTOLOGY MANIPAL COLLEGE OF DENTAL SCIENCE MANIPAL ACADEMY OF HIGHER EDUCATION MANIPAL  
Type of Sponsor  Other [self sponsor] 
 
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 BHARATH KUMAR A M  Manipal College of dental Sciences  ROOM 3 DEPARTMENT OF PERIODONTOLOGY MADHAV NAGAR
Udupi
KARNATAKA 		 8746842802

dr.bharathkumar1995@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: A488||Other specified bacterial diseases,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Use of Calendula Officinalis in wound healing after obtaining free gingival graft from the palate.  application of calendula officinalis gel at the palatal donor site after obtaining free gingival graft to assess the wound healing. 
Comparator Agent  use of PRF(platelets rich fibrin) in wound healing after obtaining free gingival graft from the palate.  Application of PRF( platelet rich fibrin) obtained from patients own blood, at the donor site after obtaining free gigival graft to assess the wound healing. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  Patients willing to participate in the study
Patients undergoing plastic surgery and requiring soft tissue graft.
Good oral hygiene
No history of periodontal surgery at the operation site
 
 
ExclusionCriteria 
Details  History of known systemic diseases like hypertension, diabetes, HIV, radiation therapy, immunosuppressive therapy, cancer.
Pregnancy/lactation
Patients with the habit of smoking and tobacco chewing
Medications known to affect the outcomes of the treatment
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Primary outcome:To observe wound closure according to the Healing Index and haemostasis.

Secondary outcome:To record Pain perception using verbal rating scale (VRS) 		 7th day, 15th day and 2 months 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary outcome:To record Pain perception using verbal rating scale (VRS)  7th day, 15th day and 2 months 
 
Target Sample Size   Total Sample Size="32"
Sample Size from India="32" 
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   Phase 4 
Date of First Enrollment (India)   29/05/2020 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Suspended 
Recruitment Status of Trial (India)  Suspended 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   Detailed description of procedure/processe
The study design is in-vivo randomized control clinical trial ­­­­­-Randomization will be done  by using computer method. The surgical procedures shall be follows:

 The subjects fulfilling the inclusion criteria will be randomized into two groups (Group A & Group B) by computer method.

 The subjects will be given the Patient information sheet (PIS) on the first day of visit.

 Maxillary impression will be taken using alginate and the cast will be prepared for all the subjects participating in the       study, then the acrylic stent will be made.
 
2ml Local anesthesia 2% lidocaine (adrenaline 1:10000) will be administered at Nasopalatine and Greater palatine on the day of surgery.

Incision will be placed using blade #15 for procurement of the palatal graft. A standard measurement of width and height (1cm x 1cm) graft will be taken from all the patients.

 10 ml of blood from antecubital vein of the patient will be collected in the sterile test tube without anticoagulant and       will  be centrifuged for – 12 min at the centrifugation speed at – 2700 RPM to obtain PRF for the Control Group B.  
 The patients who are allocated to Test group A- 1% Calendula Officinalis gel will be placed on the palatal wound and Gelatin film will be placed over and suture/glued whereas, Group B will receive Platelet Rich Fibrin (PRF) and Gelatin film will be placed over and sutured/glued.

(The 10% calendula gel will be diluted to 1% calendula by distilled water by the help of Manipal college of pharmacy.) 10% calendula officinalis is readliy available in the market (Fourrts) 

Then the stent will be placed in both the groups.

 The procured graft then will be used in periodontal surgery according to the patients requirement.ie; to increase the width of attached gingiva, miller class 1 or class 2 recession or Vestibuloplasty.
 
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