| CTRI Number |
CTRI/2025/12/098425 [Registered on: 03/12/2025] Trial Registered Prospectively |
| Last Modified On: |
03/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of two surgical techniques in the treatment of receding gums |
|
Scientific Title of Study
|
Vestibular incision subperiosteal tunnel access (VISTA) technique with collagen membrane compared to VISTA alone for treatment of multiple gingival recession defects: In vivo study |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rakshitha S |
| Designation |
Post graduate |
| Affiliation |
JSS Dental college and Hospital |
| Address |
Department of Periodontology
Room number 9
JSS Dental College and Hospital Bangalore Mysore highway Bannimantap Mysore 570015
Mysore KARNATAKA 570015 India |
| Phone |
09880355071 |
| Fax |
|
| Email |
rakshitha074@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Pratibha Shashikumar |
| Designation |
Reader |
| Affiliation |
JSS Dental college and Hospital |
| Address |
Department of Periodontology
Room number 9
JSS Dental college and Hospital Banglore Mysore highway Bannimantap Mysore 570017
Mysore KARNATAKA 570015 India |
| Phone |
9986544409 |
| Fax |
|
| Email |
drpratibhavg@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr.Shivananda S |
| Designation |
Reader |
| Affiliation |
JSS Dental college and Hospital |
| Address |
Department of Oral and Maxillofacial Surgery
Room number 6
JSS Dental college and Hospital Bangalore Mysore highway Bannimantap Mysore
dr.shivanandas@jssuni.edu.in
Mysore KARNATAKA 570015 India |
| Phone |
9343322433 |
| Fax |
|
| Email |
rakshitha074@gmail.com |
|
|
Source of Monetary or Material Support
|
| JSS Dental college and Hospital Banglore Mysore highway Bannimantap Mysore India 570015 |
|
|
Primary Sponsor
|
| Name |
JSS Dental college and Hospital |
| Address |
JSS Dental College and Hospital Bangalore Mysore highway Bannimantap Mysore India 570015 |
| 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 |
| Rakshitha S |
JSS Dental Colleg and Hopsital departement of Peridontology |
Department of Periodontology
Room number 9
JSS Dental college and Hospital Banglore Mysore highway Bannimantap Mysore
Mysore KARNATAKA |
09880355071
rakshitha074@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JSS Dental college and Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Oral conditions like Periodontitis |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Vestibular incision subperiosteal tunnel access (VISTA) technique with collagen membrane compared to VISTA alone for treatment of multiple gingival recession defects: In Vivo Study |
Control group VISTA alone |
| Intervention |
Vestibular incision subperiosteal tunnel access (VISTA) technique with collagen membrane compared to VISTA alone for treatment of multiple gingival recession defects: In Vivo Study |
Test group VISTA with collagen membrane |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Millers class 1 and class 2 recession with width of keratinized gingiva more than 1 mm and systemically healthy patients who are not smokers and absence of any carious and non carious leison |
|
| ExclusionCriteria |
| Details |
Patients who are not willing to give consent
Pregnant lactating women
Patients taking any medication known to interfere with the health or healing of periodontal tissue within 6 months of the study
Patient with history of periodontal surgery |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Clinical attachment loss Recession depth Recession Width Recession Keratinized tissue thickness Keratinized tissue width Percentage if root coverage |
Baseline 3 months 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Plaque index Gingival index |
Baseline 3 months 6 months |
|
|
Target Sample Size
|
Total Sample Size="24" Sample Size from India="24"
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 |
|
Date of First Enrollment (India)
|
12/02/2026 |
| 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="2" |
|
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 a common condition that affects both dental function and aesthetics while inflammation is the main cause factors like thin gingival biotype malpositioned teeth trauma abnormal frenum attachment and iatrogenic causes such as improper brushing or poorly designed dentures can also contribute. Various surgical techniques are used for root coverage including free gingival grafts connective tissue grafts coronally advanced flaps and guided tissue regeneration among these the coronally advanced flap with connective tissue graft is considered the gold standard though it has drawbacks such as the need for donor tissue and possible postoperative discomfort Minimally invasive tunneling methods like the Vestibular Incision Subperiosteal Tunnel Access technique developed by Zadeh offer comparable outcomes with less trauma and faster healing VISTA involves creating a small access incision to elevate a subperiosteal tunnel and using coronally anchored sutures to stabilize tissues and promote healing For root coverage various grafts and biomaterials including collagen membranes can be used collagen membranes support cell growth allow nutrient exchange are resorbable and promote wound healing while reducing the risk of infection or membrane exposure. |