| 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
|
|
|
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
|
|
|
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. |
|
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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). |