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CTRI Number  CTRI/2017/03/007988 [Registered on: 02/03/2017] Trial Registered Prospectively
Last Modified On: 06/11/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   A study to test different treatment options in patients with receding gums. 
Scientific Title of Study   Comparison of platelet rich fibrin, periosteal pedicle graft and subepithelial connective tissue graft in treatment of Millers Class I &/or II gingival recession on multiple adjacent teeth- Randomized controlled trial. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Raghavendra S Medikeri 
Designation  Professor 
Affiliation  Sinhgad Dental College and Hospital 
Address  Sinhgad Dental College and Hospital, STEs campus, s.no 44/1, vadgaon Bk, off sinhgad road, pune, maharashtra, india
STEs campus, s.no 44/1, vadgaon Bk, off sinhgad road, pune, maharashtra, india
Pune
MAHARASHTRA
411041
India 
Phone  9766337620  
Fax    
Email  dr_raghum2000@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Raghavendra S Medikeri 
Designation  Professor 
Affiliation  Sinhgad Dental College and Hospital 
Address  Sinhgad Dental College and Hospital, STEs campus, s.no 44/1, vadgaon Bk, off sinhgad road, pune, maharashtra, india
STEs campus, s.no 44/1, vadgaon Bk, off sinhgad road, pune, maharashtra, india
Pune
MAHARASHTRA
411041
India 
Phone  9766337620  
Fax    
Email  dr_raghum2000@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Vinayak Meherwade 
Designation  Reader 
Affiliation  Sinhgad Dental College and Hospital 
Address  Sinhgad Dental College and Hospital, STEs campus, s.no 44/1, vadgaon Bk, off sinhgad road, pune, maharashtra, india.
STEs campus, s.no 44/1, vadgaon Bk, off sinhgad road, pune, maharashtra, india
Pune
MAHARASHTRA
411001
India 
Phone  9422304567  
Fax    
Email  drmvinayak@gmail.com  
 
Source of Monetary or Material Support  
Singad Dental College and Hospital, STEs campus, S.No 44/1, Vadgaon Bk, Off Sinhgad road, Pune, Maharashtra, India. 
 
Primary Sponsor  
Name  Singad Dental College and Hospital 
Address  STEs campus, s.no 44/1, vadgaon Bk, off sinhgad road, pune, maharashtra, india 
Type of Sponsor  Research institution and hospital 
 
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 Raghavendra S Medikeri  Sinhgad Dental Hospital  Room No; 04, Department of Periodontology, Surgical (Post-graduate) Section, S.no: 44/1, STES Campus, Vadgaon (Bk.), Off Sinhgad Road, Pune - 411041
Pune
MAHARASHTRA 		 9766337620

dr_raghum2000@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Systemically healthy participants in the age group of 18 years and above, having Miller class I and or II gingival recession on adjacent 2-3teeth and full mouth plaque score of 1 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  group 1: modified coronally positioned flap with platelet-rich fibrin  modified coronally flap is elevated, platelet-rich-fibrin is place over the recession defect and flap positioned coronally and sutured 
Intervention  Group 2: Modified coronally positioned flap with Periosteal pedicle graft and platelet-rich-fibrin  modified coronally flap is elevated beyond 4-5 mm apical to recession defects, periosteal flap is elevated bluntly from underlying bone. platelet-rich-fibrin is placed over denuded root surface and covered with periosteal pedicle graft over the recession defect. Both platelet-rich-fibrin and pedicle graft is secured with resorbable sutures  
Intervention  Group 2: Modified coronally positioned flap with Periosteal pedicle graft.  modified coronally flap is elevated beyond 4-5 mm apical to recession defects, periosteal flap is elevated bluntly and reflected over the recession defect and secured with resorbable sutures. partial thickness flap positioned coronally and sutured. 
Comparator Agent  Group 3: Subepithelial connective tissue graft with coronally advanced flap.  tension free Modified coronally flap is elevated on recepient sites. Connective tissue graft is harvested from palatal region of maxillary arch and transferred to recipient site covering entire denuded root surface. Partial thickness flap positioned coronally and sutured. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Systemically healthy participants
2. Millers class I and or II gingival recession on adjacent two to three teeth.
3. Gingival recession depth of atleast one mm
4. Full mouth plaque score less than one.
5. Subjects willing to comply with the study related procedures.
6. Subjects willing to give written consent 
 
ExclusionCriteria 
Details  1. Medically compromised conditions that contraindicate periodontal surgery.
2. Subjects unable to perform routine oral hygiene procedure or poor patient patient compliance.
3. Pregnant or Lactating females.
4. Mucosal disorders at surgical sites. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Centralized 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
to evaluate clinical root coverage, probing depth, clinical attachement level, attached ginigval gain and esthetic outcome obtained all methods.  At baseline, post-operative 3 and 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Patient comfort, complications suah as hematoma, pain, swelling, etc.  during surgery and post- surgical upto 6 months. 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "24"
Final Enrollment numbers achieved (India)="24" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   15/03/2017 
Date of Study Completion (India) 04/06/2018 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 not published yet. 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Successful coverage of exposed root is necessary for esthetic and functional reasons. A variety of surgical techniques have been used to cover recession  type defects. Subepithelial connective tissue graft (SCTG) is considered gold standard for treatment of gingival recession1,2,3. Modified coronally advanced flap (MCAF) operation  offers  a   predictable,  simple  and  convenient     approach  as  a   root coverage procedure in Miller’s class I and II recession defects.4 Combining this technique with addition of platelet rich fibrin (PRF) improves outcomes like root coverage, amount of gingival thickness and keratinized tissue width at surgical site5

Periosteum is a highly vascular connective tissue with immense regenerative potential. It   contain fibroblasts &   their progenitor cells & stem cells. In all age groups, cells of periosteum retain ability to differentiate into various types of cells. Recent  studies   have   shown  that  periosteal   pedicle  graft  (PPG)   resulted   in increased root coverage, width of attached gingival & keratinized gingiva.2,5

All those treatment modalities give good result, with predictability of root coverage, widening of attached and keratinized gingiva. To best of our knowledge, there is no study which compares PRF, PPG and SCTG in the treatment of gingival recession. Hence, the purpose of this study is to compare clinical outcomes of PRF, PPG and SCTG in treatment of miller’s class I & II gingival recession in multiple adjacent teeth.

 
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