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CTRI Number  CTRI/2019/05/019328 [Registered on: 24/05/2019] Trial Registered Prospectively
Last Modified On: 04/12/2019
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Treatment of gum recession 
Scientific Title of Study   Evaluation of Patient Centered outcome with Platelet Rich Fibrin Membrane and Sub-Epithelial Connective Tissue Graft for the Treatment of Gingival Recession 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ruchika Lulla 
Designation  PG student  
Affiliation  Sharad Pawar Dental College  
Address  Nanak Nagar Near Nankani Mangal Karyalaya, Rampuri Camp Amravati
Datta Meghe Institute of Medical Sciences Sharad Pawar Dental College, Sawangi (M), Wardha
Wardha
MAHARASHTRA
444603
India 
Phone  7588752199  
Fax    
Email  ruchika.lulla@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Priyanka Jaiswal  
Designation  Associate Professor 
Affiliation  Sharad Pawar Dental College 
Address  Sharad Pawar Dental College, Sawangi (M) Wardha
Datta Meghe Institute of Medical Sciences Sharad Pawar Dental College Sawangi (M)
Wardha
MAHARASHTRA
442004
India 
Phone  9960713010  
Fax    
Email  priyanka.banode@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Priyanka Jaiswal  
Designation  Associate Professor 
Affiliation  Sharad Pawar Dental College 
Address  Sharad Pawar Dental College, Sawangi (M) Wardha
Datta Meghe Institute of Medical Sciences Sharad Pawar Dental College Sawangi (M)
Wardha
MAHARASHTRA
442004
India 
Phone  9960713010  
Fax    
Email  priyanka.banode@gmail.com  
 
Source of Monetary or Material Support  
Datta Meghe Institute of Medical Sciences Sharad Pawar Dental College Sawangi (M)  
 
Primary Sponsor  
Name  not applicable 
Address  not applicable 
Type of Sponsor  Other [not applicable] 
 
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 Ruchika Lulla  Sharad Pawar Dental College  Room No. 3 Dept. of Periodontics PG section
Wardha
MAHARASHTRA 
7588752199

ruchika.lulla@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE DATTA MEGHE INSTITUTE OF MEDICAL SCIENCES  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 4||Measurement and Monitoring,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Platelet Rich Fibrin Membrane  Multiple gingival recession defects will be treated with platelet rich fibrin membrane and patient centered outcomes will be evaluated following and during post-operative follow-up with the help of questionnare 
Comparator Agent  Sub-epithelial connective tissue graft  Multiple gingival recession defects will be treated with sub-epithelial connective tissue graft and patient centered outcomes will be evaluated following and during post-operative follow-up with the help of questionnaire 
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1. Presence of multiple gingival recession (more than one) defects on the labial/ buccal surfaces of the teeth either in maxilla or mandible classified as either Miller’s Class I or II.
2. Presence of ≥ 2 mm gingival recession depth
3. Radiographic evidence of sufficient interdental bone (the distance between the crestal bone and cementoenamel junction as ≤ 2mm).
4. Presence of adequate width of keratinized gingiva apical to recession.
 
 
ExclusionCriteria 
Details  1. Patients using tobacco products and smokers.
2. Un-cooperative patients.
3. Patients with unacceptable oral hygiene after phase I therapy and showing plaque score ≥1.
4. History of periodontal surgical treatment in quadrant selected for the study.
5. Pregnant lady or lactating mother.
6. Presence of badly caries teeth
7. Presence of mobile teeth.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
Patient centered/ Subjective  Baseline, one week, one month, 3 months and 6 months  
 
Secondary Outcome  
Outcome  TimePoints 
gain in CAL   one week, one month, 3 months and 6 months  
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
Final Enrollment numbers achieved (Total)= "20"
Final Enrollment numbers achieved (India)="20" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   27/05/2019 
Date of Study Completion (India) 03/12/2019 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 03/12/2019 
Estimated Duration of Trial   Years="0"
Months="7"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
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  

Gingival recession is exposure of the root surface due to apical migration of the gingival margin. It is a common problem in the general population and often leads the patient to seek treatment. Mucogingival therapy may be required to prevent further recession, correct esthetic problems, aid plaque control, and reduce dentin hypersensitivity. The patients today are increasingly conscious of personal appearance and much attention has been focused on denuded roots that are exposed during smiling which look unaesthetic. CAF with SCTG is accepted as the gold standard and has shown greater predictability for obtaining complete root coverage. However, the SCTG technique has some disadvantages. It is time consuming, increases morbidity, requires a second surgery, and leads to postoperative pain and bleeding, and the supply of donor tissue is limited. 

            PRF is a second-generation platelet concentrate prepared from centrifuged blood. It is a modification of PRP and has some advantages, such as ease of preparation/application, minimal expense, and lack of biochemical modification (no bovine thrombin or anticoagulant is required). Because of PRF’s natural fibrin framework properties, growth factors can maintain their activity for a relatively longer period and effectively stimulate cell migration, wound healing, and tissue regeneration. Recent studies have demonstrated that PRF has a significant slow, sustained release of key growth factors for at least 1 week  and up to 28 days, which means that PRF could stimulate its environment for a significant time during wound healing. It activates the vascular system and releases growth factors involved in soft tissue healing. The PRF membrane can be considered as an effective healing biomaterial. It features all the essential parameters permitting optimal healing. PRF membrane consists of a fibrin 3D mesh polymerized in a specific structure; the incorporation of platelets, leukocytes, and growth factors; and the presence of circulating stem cells. Furthermore, to our knowledge, only one study has tried to compare professional and patient esthetic satisfaction after root-coverage procedures. The results of this study showed that esthetic judgment of the periodontists may not always be consistent with patient satisfaction. Patients were influenced more by the soft-tissue integration variables than by the percentage of root coverage; and patients appeared to rate the cosmetic results more favorably than did the professionals.

             Therefore, the present study will be undertaken to compare the patient related esthetic outcome following Platelet rich fibrin (PRF) membrane with that of Sub epithelial connective tissue graft (SCTG) in Miller Class I and II multiple Gingival recession defects.  
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