| CTRI Number |
CTRI/2026/02/104214 [Registered on: 18/02/2026] Trial Registered Prospectively |
| Last Modified On: |
13/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
comparison of two gum surgery methods using patients own blood product for treatment of receding gums |
|
Scientific Title of Study
|
Comparative Evaluation of Bernotti V-Y Plasty with T-PRF and Semilunar Coronally Advanced Flap with T-PRF in Management of Gingival Recession – A Randomized Clinical 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 Yatheesh H D |
| Designation |
Post Graduate Student |
| Affiliation |
KVG Dental College and Hospital Sullia |
| Address |
Room no 11
department of periodontology
KVG Dental college and hospital kurunjibhag
sullia dakshina kannada Karnataka India 574327
Dakshina Kannada
KARNATAKA
574327
India |
| Phone |
8296112488 |
| Fax |
|
| Email |
yatheeshhd44@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prakash Pai G |
| Designation |
Professor |
| Affiliation |
KVG Dental College and Hospital Sullia |
| Address |
Room no 11
department of periodontology
KVG Dental college and hospital kurunjibhag
sullia dakshina kannada Karnataka India 574327
Dakshina Kannada
KARNATAKA
574327
India |
| Phone |
9845156405 |
| Fax |
|
| Email |
prakashpaipai2014@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prakash Pai G |
| Designation |
Professor |
| Affiliation |
KVG Dental College and Hospital Sullia |
| Address |
Room no 11
department of periodontology
KVG Dental college and hospital kurunjibhag
sullia dakshina kannada Karnataka India 574327
Dakshina Kannada
KARNATAKA
574327
India |
| Phone |
9845156405 |
| Fax |
|
| Email |
prakashpaipai2014@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Yatheesh H D |
| Address |
Room no 11
department of periodontology
KVG Dental college and hospital kurunjibhag
sullia dakshina kannada Karnataka India 574327 |
| Type of Sponsor |
Other [self] |
|
|
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 |
| Dr Yatheesh H D |
KVG dental college and hospital |
Room no 11
department of periodontology
KVG Dental college and hospital kurunjibhag
sullia dakshina kannada Karnataka India 574327
Dakshina Kannada
KARNATAKA |
8296112488
yatheeshhd44@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KVG Dental College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K055||Other periodontal diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bernotti V-Y Plasty with T-PRF |
Patients with gingival recession will be randomly allocated to receive Bernotti V Y plasty with placement of autologous titanium prepared platelet rich fibrin membrane for management of gingival recession and achievement of root coverage. The total duration of procedure is around 30 minutes. |
| Comparator Agent |
Semilunar Coronally Advanced Flap with T-PRF |
Patients with gingival recession will be randomly allocated to receive semilunar coronally advanced flap with placement of autologous titanium prepared platelet rich fibrin membrane for management of gingival recession and achievement of root coverage. The total duration of procedure is around 20 minutes. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Systemically healthy patient.
Subjects with age group of 18 to 50 years.
Subjects who are non-smokers.
Subjects free from blood-borne infections and without any systemic conditions affecting coagulation.
Subjects not on anticoagulant medication.
Subjects presenting with gingival recession defects in mandibular or maxillary teeth, particularly RT1 gingival recession.
Subjects showing no mobility or rotation, and having periodontal pocket depth less than or equal to 3 mm.
Subjects having a minimum of 2-3 mm width of attached gingiva
|
|
| ExclusionCriteria |
| Details |
Smokers
Pregnant and lactating women
Systemic and debilitating diseases
Use of antibiotics during the last six months.
Patients with bleeding disorder
Patients taking antiplatelet therapy and anticoagulant therapy
Patients with severe hepatic impairment or renal disease
Subjects having a total platelet count lower than 150,000 per mm3.
Subjects having medical conditions that compromised tissue healing (osteoporosis, anemia, etc.)
The presence of other gingival diseases (such as leukoplakia, lichen planus, pemphigoid disorders, pemphigus vulgaris, herpetic lesions, Necrotizing Ulcerative Periodontitis (NUP)
Subjects with prior periodontal treatment within the preceding six months
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the clinical outcomes of Bernotti V-Y Plasty and semilunar coronally advanced technique using T-PRF membrane in the treatment of gingival recession |
baseline
1month
3month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the gingival thickness, keratinized tissue width, clinical attachment level, root coverage ratio following Bernotti V-Y Plasty with T-PRF.
To evaluate the gingival thickness, keratinized tissue width, clinical attachment level, root coverage ratio following semilunar coronally advanced technique with T-PRF.
To compare the treatment outcome following semilunar coronally advanced technique and Bernotti V-Y Plasty technique with T-PRF.
|
baseline 1month 3month |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 2 |
|
Date of First Enrollment (India)
|
13/04/2026 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
This study is a randomized clinical trial designed to compare the clinical effectiveness of Bernotti’s V Y plasty with T PRF and semilunar coronally advanced flap with T PRF in the management of gingival recession. Systemically healthy patients aged 18 to 50 years presenting with isolated gingival recession defects will be included. Eligible sites will be randomly allocated into two groups. Group A will be treated using Bernotti’s V Y plasty with T PRF and Group B will be treated using semilunar coronally advanced flap with T PRF. Clinical parameters including recession depth clinical attachment level and width of keratinized gingiva will be recorded at baseline one month and three months post operatively. The study aims to evaluate and compare the root coverage outcomes and early healing between the two techniques |