| CTRI Number |
CTRI/2024/06/069312 [Registered on: 20/06/2024] Trial Registered Prospectively |
| Last Modified On: |
09/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
multiple gum recession treatment using two different technique TCAF vs VISTA with CTG |
|
Scientific Title of Study
|
Root coverage with tunneled coronally advanced flap (TCAF) Versus vestibular incisional subperiosteal tunnel access (VISTA) in combination with connective tissue graft (CTG) in multiple adjacent gingival recession: A Randomized Controlled 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 Nihal Devkar |
| Designation |
professor |
| Affiliation |
Sinhgad dental college and hospital |
| Address |
department of periodontoogy ,room No. 4,devision -2 floor ,Sinhgad dental college and hospital , pune
Pune
MAHARASHTRA
411041
India |
| Phone |
9420481441 |
| Fax |
|
| Email |
drdevkar@gamil.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nihal Devkar |
| Designation |
professor |
| Affiliation |
Sinhgad dental college and hospital |
| Address |
Department of periodontology , room no.4, devision -2 floor,Sinhgad dental college and hospital , pune
Pune
MAHARASHTRA
411041
India |
| Phone |
9420481441 |
| Fax |
|
| Email |
drdevkar@gamil.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nihal Devkar |
| Designation |
professor |
| Affiliation |
Sinhgad dental college and hospital |
| Address |
Department of periodontology, room no.4, devision -2 floor,Sinhgad dental college and hospital , pune
Pune
MAHARASHTRA
411041
India |
| Phone |
9420481441 |
| Fax |
|
| Email |
drdevkar@gamil.com |
|
|
Source of Monetary or Material Support
|
| self
department of periodontology , Sinhgad dental college and hospital , pune |
|
|
Primary Sponsor
|
| Name |
Dr. Payoshni kalamkar |
| Address |
S.No.44/1,vadgaon Budruk,off,Sinhgad road,pune, maharashtra 411041,india |
| 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 Payoshni Kalamkar |
Sinhgad dental college and hospital |
Department of periodontoloy , room no. 4 ,Sinhgad dental college and hospital.pune
Pune
MAHARASHTRA |
9604280498
payoshnikalamkar4@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Sinhgad Dental College and Hospital,Pune |
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 |
Tunneled coronally advanced flap(TCAF) with CTG |
Tunneled coronally advanced flap with CTG in treatment of multiple adjacent gingival recession , and assesment after 3months and 6 months after surgry |
| Comparator Agent |
Vestibular incisional subperiosteal tunnel access (VISTA) with CTG |
Vestibular incisional subperiosteal access with CTG in treatment of multiple adjaent gingival recession and assesment after 3 months , 6 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Systemically healthy patients with age between 18 and 60 yrs.
2.At least 20 natural teeth should be present.
3.At least two adjacent Millers class I and II / Cairo RT1 recession defects from 2nd premolar right side to 2nd premolar left side in maxillary and mandibular arches.
4. Patients with healthy periodontal conditions.
5.Patients with esthetic concerns.
6.Identifiable CEJ or CEJ of a contralateral homologous tooth or adjacent teeth is used to replicate the lost CEJ.
7.Patients willing to participate and willing to sign an informed consent.
|
|
| ExclusionCriteria |
| Details |
1.Systemic conditions and diseases that could affect the progression of periodontal disease.
2.Patients those who underwent any subgingival periodontal therapy or antibiotic therapy in past 6 months.
3.Patients using smokeless as well as smoking form of tobacco.
4.Pregnant and lactating females.
5.Patients with mal-aligned teeth.
6.Patients with recently undergone Orthodontic treatment.
7.Patients with prosthesis on the teeth with recession
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare complete root coverage (CRC) in multiple adjacent gingival recessions at baseline ,3 months ,6 months after surgery using TCAF vs VISTA technique in combination with CTG. |
baseline,3months , 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare clinical parameters like Recession depth(RD), recession width(RW),Mean Root Coverage (MRC), keratinized tissue width (KTW),Width of attached gingiva (WAG),Root coverage esthetic score (RES),at baseline,3 months, 6 months. Patient related outcome measure- Visual analogue scale(VAS),in multiple adjacent gingival recessions at first week, second week after surgery,using TCAF vs VISTA in combination with CTG . And Time of procedure for both groups. |
baseline, 3 months , 6 months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "20"
Final Enrollment numbers achieved (India)="20" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
29/07/2024 |
| Date of Study Completion (India) |
25/12/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
| Gingival recession is the exposure of the root surface resulting from migration of the gingival margin apical to the cemento-enamel junction(CEJ)1.Multiple adjacent gingival recession (MAGR) is common and various techniques have been described for its treatment,[e.g. Coronally advanced flap (CAF)2,tunnel technique (TUN)3,Envelope flap designs adjuncts [e.g., free gingival graft (FGG), connective tissue graft(CTG),enamel matrix derivatives (EMD)4, soft tissue substitutes(STS) membranes for guided tissue regeneration (GTR)5,etc. and combinations there-of have been tried. The coronally advanced flap (CAF)2and the tunnel technique (TUN)3are the most performed surgical approaches for treating gingival recessions (GRs). Nonetheless, these two approaches have commonly been regarded as substitutes for one another, and clinicians are often faced with the choice of performing only one during root coverage procedures. The aim is to describe a surgical design in which the benefits of both the CAF and the TUN are combined for the treatment. Vestibular incisional subperiosteal tunnel access (VISTA) is a minimally invasive approach to treat multiple gingival recession, some studies are done with combination of CTG, PRF with VISTA which gives better result in reduction of gingival recession. TCAF technique is introduced by Dr. Shayan Barootchi and Dr. Lorenzo Tavelli, in 2022, it is specifically designed for soft tissue grafting via the Coronally Advanced Flap (CAF), the Tunnel approach (TUN), and their combination (TCAF). Very few articles are published on this technique which concluded potential of TCAF technique to enhance flap blood supply and graft vascularization and improve clinical, esthetic, and patient-reported outcomes compared with conventional surgical techniques. | There are no enough studies that compare tunneled coronally advanced flap (TCAF) vs vestibular incisional subperiosteal access (VISTA) for treatment of adjacent multiple gingival recession. Therefore, this study is aimed to evaluate the efficacy and performance of TCAF technique vs VISTA technique in treatment of multiple adjacent gingival recession. |