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CTRI Number  CTRI/2026/01/100525 [Registered on: 08/01/2026] Trial Registered Prospectively
Last Modified On: 10/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of root coverage using mixed thickness tunnel technique with albumin platelet rich fibrin or albumin PRF with bone graft biobone in RT1 recession a randomized control study 
Scientific Title of Study   Comparison of root coverage using mixed thickness tunnel technique with albumin platelet rich fibrin or albumin PRF with bone graft biobone in RT1 recession a randomized control study 
Trial Acronym  NILL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Tifana Fathima H 
Designation  Postgraduate Student 
Affiliation  Bapuji Dental College and Hospital 
Address  Department of Periodontics Bapuji Dental College and Hospital, Davangere Karnataka – 577004 India

Davanagere
KARNATAKA
577004
India 
Phone  8848776785  
Fax    
Email  tifanafathima07550@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Sowmya N K 
Designation  Professor 
Affiliation  Bapuji Dental College and Hospital 
Address  Department of Periodontics Bapuji Dental College and Hospital, Davangere Karnataka – 577004 India

Davanagere
KARNATAKA
577004
India 
Phone  9481672521  
Fax    
Email  drsowmyamds@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Sowmya N K 
Designation  Professor 
Affiliation  Bapuji Dental College and Hospital 
Address  Department of Periodontics Bapuji Dental College and Hospital, Davangere Karnataka – 577004 India

Davanagere
KARNATAKA
577004
India 
Phone  9481672521  
Fax    
Email  drsowmyamds@gmail.com  
 
Source of Monetary or Material Support  
Bapuji Dental College and Hospital, Davangere, Karnataka, India – 577004 
 
Primary Sponsor
Modification(s)  
Name  Tifana Fathima H 
Address  Department of Periodontics Bapuji Dental College and Hospital Davangere, Karnataka – 577004 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 
DrTifana Fathima H  Bapuji Dental College and Hospital  Room No. 5, Department of Periodontics, Davangere, Karnataka, India – 577004
Davanagere
KARNATAKA 
8848776785

tifanafathima07550@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  Albumin-Platelet Rich Fibrin (ALB-PRF) and Albumin-Platelet Rich Fibrin (ALB-PRF) + BONE GRAFT (BIOBONE)  Preparation of Alb-PRF- 9 ml of blood will be drawn into plastic test tubes without anticoagulants and other additives. Centrifugation will be performed at 700 g for 8 minutes. After the completion of centrifugation, a syringe will be used to evacuate 2 ml of Platelet poor plasma from the top. A cap will be placed on the syringe, and it will be heated at 75°C for 10 minutes. After 1-2min cooling, the formed ALB gel is dispensed into a customized tray and condensed for uniform distribution. Using another syringe reaming 2 ml of C-PRF is drawn and distributed over the ALB gel. Which then allowed to clot together for 15 minutes to form Alb-PRF. Preparation of bio bone- After cooling for 1-2 minutes, the formed ALB gel is dispensed into a customized tray and spread out evenly and gently compacted. Using another syringe, 2 ml of liquid C-PRF is drawn and distributed evenly over the ALB gel. Before it clots, bone graft is added then compacted for even distribution. Additional liquid C-PRF is added over bone graft to ensure that it is properly soaked. This is allowed to set for 10-15 min.  
Intervention  Mixed thickness tunnel technique (MiTT)   A vertical incision will be performed laterally to the base of the papilla and 1-2 mm apical to the mucogingival junction (MGJ) on the mucosa. subsequently using specialized tunneling tools, the mucosa will be initially separated from the muscles below the MGJ in a split design pattern. After that, using microsurgical blades, intrasulcular incisions up to one neighboring tooth will be produced. Subperiosteal access from the MGJ will then be utilized to raise a full-thickness tunnel using specialist tunneling instruments. In order to maintain local vascularization, one adjacent tooth will be included in this process. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1. Male and female subjects of age 20- 50 years.

2. Patients with good general health and good oral hygiene.

3. Presence of at least two adjacent gingival recessions of RT I which is ≥ 1 mm either in maxilla or mandibular arch.
 
 
ExclusionCriteria 
Details  1. Patients with systemic conditions (such as uncontrolled diabetes and Hypertension) that would contraindicate the surgical procedures and the patients who are on medications which is known to interfere with periodontal healing.
2. Pregnant or lactating mother.
3. Patients having any Infectious diseases such as hepatitis, tuberculosis and HIV.
4. Patients who are smokers and tobacco users.
 
 
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   6 months 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the thickness of labial plate and gingiva   6 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)   20/01/2026 
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  

The displacement of the gingival margin apical to the cementoenamel junction results in gingival recession, accompanied by clinical attachment loss and bone loss, causing dentinal hypersensitivity, cervical root abrasion, problems with plaque removal, and aesthetic difficulties.

    To address these concerns numerous conventional therapeutic approaches, such as the coronally advanced flap, laterally placed flap, and double papilla flap, have been used however these techniques often require vertical releasing incisions and papillae incisions, leading to postoperative morbidity and prolonged surgical time.

    To overcome these drawbacks minimally invasive techniques such as envelope technique, pouch and tunnel technique, pinhole technique, vestibular incision subperiosteal tunnel approach, and recently mixed thickness tunnel access (MiTT) have been utilized which minimizes tissue trauma, reduce scarring, maintain blood supply and also enhances tissue adaptability. Top of Form

 To sustain space for cell proliferation and to retain long-term clinical efficacy additives such as connective tissue grafts, platelet concentrates, or commercially available guided tissue regeneration (GTR) membranes are used along with root coverage surgical procedures.

   While connective tissue grafting remains the gold standard for treating gingival recession, other options are being used as it requires a second surgical site and causes discomfort to the patient. Autologous Platelet concentrates, which are a highly concentrated reservoirs of growth factors and is crucial for tissue healing and regeneration, obtained via gradient density centrifugation. However, despite their profound healing potential, conventional platelet concentrates often face the challenge of faster resorption during the healing process.

     The novel heat-compressed Albumin-PRF (Alb-PRF) addresses these limitations by exhibiting an extended resorption period exceeding 4 -6 months, along with enhanced tissue regeneration and prolonged release of growth factors.

     Achieving comprehensive root coverage necessitates the regeneration of soft tissue and as well as hard tissues. This can be accomplished through the synergistic combination of Alb-PRF with particulate bone graft results in the formation of a cohesive mass i.e., bio bone. This structure offers mechanical scaffolding support by entwining particulate bone powders, platelets, and leukocytes within a fibrin network. It imped soft tissue ingrowth into the graft also accelerates tissue healing and mitigates bone loss during the healing phase.

     To our best knowledge, till date no study has been conducted to assess and compared the efficacy of Alb-PRF and Alb-PRF+ bone graft (Bio bone) for root coverage. Hence, the aim of this study is to evaluate and compare the efficacy Alb-PRF and Alb-PRF+ bone graft (Bio bone) for root coverage with mixed thickness tunnel technique (MiTT).

 
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