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CTRI Number  CTRI/2025/09/094157 [Registered on: 03/09/2025] Trial Registered Prospectively
Last Modified On: 03/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Management of gingival recession with connective tissue graft or Albumin platelet rich fibrin with coronally advanced flap  
Scientific Title of Study   Comparison of connective tissue graft(CTG) OR Albumin- platelet rich fibrin (ALB-PRF)with coronally advanced flap in the management of RT1 type gingival recession:A Randomized Control Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Jency George Cheruvathoor 
Designation  Postgraduate 
Affiliation  Department of Periodontics Bapuji Dental College and Hospital Davangere 
Address  Department of Periodontics, Bapuji Dental College and Hospital,Davangere 577004 Karnataka India

Davanagere
KARNATAKA
577004
India 
Phone  8778712442  
Fax    
Email  jencygeorge007@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rucha Shah 
Designation  Professor 
Affiliation  Department of Periodontics Bapuji Dental College and Hospital Davangere 
Address  Department of Periodontics Bapuji Dental College and Hospital Davangere 577004 Karnataka India

Davanagere
KARNATAKA
577004
India 
Phone  7676279879  
Fax    
Email  srucha2k@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Jency George Cheruvathoor 
Designation  Postgraduate 
Affiliation  Department of Periodontics Bapuji Dental College and Hospital Davangere 
Address  Department of Periodontics Bapuji Dental College and Hospital Davangere 577004 Karnataka India

Davanagere
KARNATAKA
577004
India 
Phone  8778712442  
Fax    
Email  jencygeorge007@gmail.com  
 
Source of Monetary or Material Support  
Bapuji Dental College and Hospital,Davangere,Karnataka,India,Pin Code-577004 
 
Primary Sponsor  
Name  Self 
Address  Department of Periodontics Bapuji Dental College and Hospital Davangere Karnataka,India,Pin Code-577004 
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 
DrJency George Cheruvathoor  Bapuji Dental College and Hospital  Room number 5, Department of Periodontics ,Bapuji Dental College and Hospital Davangere,Karnataka,India
Davanagere
KARNATAKA 		 8778712442

jencygeorge007@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Review Board,Bapuji Dental College and Hospital,Davangere  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  Coronally advanced flap with Albumin-Platelet Rich Fibrin  Coronally advanced flap design will begin with two horizontal incisions on either side of the recession defect. These incisions will be placed from the tip of the papillae at an equal distance to the recession depth . After these horizontal incisions, there will be two divergent, bevelled oblique incisions that extend into alveolar mucosa. The resulting trapezoidal-shaped flap will be elevated using small periosteal elevator in the coronal–apical direction in split–full–split method. In order to form tissue beds onto which the surgical papillae can be attached, the facial soft tissue of the anatomic inter-dental papillae coronal to the horizontal incisions will be deepithelialized.Coronally advanced flap will be advanced 1-2mm coronal to Cemento enamel junction and sutured to compensate soft tissue shrinkage.Albumin platelet rich fibrin will be prepared .Blood will be collected in 9ml S-PRF tubes. After collecting, it will be placed in the centrifuge, along with filled water tube in order to maintain the balance during centrifuging for 8 minutes at 2700 rpm . About 2 ml of the initial portion of plasma will be collected using a syringe, while the rest of the blood contents will be preserved at a cool temperature . The syringe containing platelet poor plasma (PPP) will be heated for 10 minutes at a temperature of 70-75 degree Celsius. After the heating is done, the syringe will be kept at room temperature for another 10 minutes to allow cooling. Following this, formed albumin gel is deposited in glass container to obtain required shape. Subsequently, using 10ml syringe, remaining cells and growth factors in buffy coat will be mixed with gel. After waiting for 15 minutes for polymerization to occur, Albumin PRF will be formed.This formed Albumin PRF will be positioned and stabilized with suture in desired position. The released flap would cover Alb-PRF  
Intervention  Coronally advanced flap with connective tissue graft  Coronally advanced flap design will begin with two horizontal incisions on either side of the recession defect. These incisions will be placed from the tip of the papillae at an equal distance to the recession depth . After these horizontal incisions, there will be two divergent, bevelled oblique incisions that extend into alveolar mucosa. The resulting trapezoidal-shaped flap will be elevated using small periosteal elevator in the coronal–apical direction in split–full–split method. In order to form tissue beds onto which the surgical papillae can be attached, the facial soft tissue of the anatomic inter-dental papillae coronal to the horizontal incisions will be deepithelialized.Coronally advanced flap will be advanced 1-2mm coronal to Cemento enamel junction and sutured to compensate soft tissue shrinkage.A free (de-epithelialized) gingival graft will be harvested from the palate. Two horizontal and two vertical incisions will be traced to delineate area to be grafted. Along the coronal horizontal incision, the blade will be oriented almost perpendicular to the bone plate. Once adequate soft tissue thickness is obtained, blade will be rotated parallel to superficial surface. The thickness of graft would be maintained uniform while proceeding parallel to blade. The graft would be de-epithelialized with a 15c blade kept parallel to external surface.Harvested Graft will be sutured to recipient site. Flap will cover the graft and be stabilized  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  General
1) Plaque score ≤ 20% after phase 1 therapy
Site Specific
1) Cairo et.al. RT 1 Type gingival recession
2) ≥ 2mm of keratinized gingiva apical to recession defect
 
 
ExclusionCriteria 
Details  Smokers, Pregnant and Lactating mothers, Patients who are not available for follow up. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess percentage of root coverage  4 MONTHS 
 
Secondary Outcome  
Outcome  TimePoints 
To assess Root coverage esthetic score(RES)  4 MONTHS 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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 3/ Phase 4 
Date of First Enrollment (India)   01/10/2025 
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="0"
Months="9"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Gingival recession is defined as the displacement of marginal gingiva apical to cement-enamel junction causing root exposure. Connective tissue graft (CTG) with coronally advanced flap is currently the gold standard for recession coverage. However, soft tissue graft substitutes are alternative option to autogenous grafts, especially in clinical scenarios  like insufficient tissue to harvest from the palate, the need for multiple surgical procedures to harvest from the same donor site in a short time period, patient morbidity, and medical contraindications to graft harvesting.  Platelets initiate regeneration by releasing growth factors .  Hence platelet rich fibrin has emerged as an interesting surgical additive due to its angiogenesis, immunomodulatory and antimicrobial properties.Several modifications of original platelet rich fibrin (PRF) protocol have been proposed; however, all the membrane generated such as Advanced–PRF(A-PRF) and A-PRF+ have desorption time of only 10-14 days in vivo.A novel technique was proposed by Richard J. Miron in 2020 wherein for 10min platelet poor plasma (PPP) was heated at 750 C causing denaturation and clumping of proteins in gel form to which the upper layer of buffy-coat rich in growth factors was aspirated and mixed with gel to produce albumin PRF (Alb-PRF).  This extended PRF was degraded in 4-6 months,overcoming the drawbacks of previous  PRF membranes formed.In this study the gold standard technique of Coronally advanced flap and  connective tissue graft is compared with coronally advanced flap and Albumin Platelet rich fibrin for management of RT1 Type gingival recession. 
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