| CTRI Number |
CTRI/2026/01/101731 [Registered on: 21/01/2026] Trial Registered Prospectively |
| Last Modified On: |
20/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological
Surgical/Anesthesia
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare gum recession using Vista Technique by 2 grafts, either prf or amniotic membrane |
|
Scientific Title of Study
|
Clinical Evaluation of Platelet Rich Fibrin versus Amniotic Membrane in treatment of Multiple Gingival Recession Defects using VISTA technique - A Randomised Clinical and 3-D Scan 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 |
Dr Charvi Raheja |
| Designation |
Post Graduate |
| Affiliation |
Dr. Harvansh Singh Judge Institute of Dental Sciences and Hospital, Chandigarh |
| Address |
Room no. 108
Department of Periodontic
Dr. Harvansh Singh Judge Institute of Dental Sciences and Hospital PU, Chandigarh, Sector 25
Chandigarh
CHANDIGARH
160014
India |
| Phone |
06283727893 |
| Fax |
|
| Email |
charviraheja75@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Charvi Raheja |
| Designation |
Post Graduate |
| Affiliation |
Dr. Harvansh Singh Judge Institute of Dental Sciences and Hospital, Chandigarh |
| Address |
Room no. 108
Department of Periodontics
Dr. Harvansh Singh Judge Institute of dental sciences and hospital PU, Sector 25, Chandigarh
Chandigarh
CHANDIGARH
160014
India |
| Phone |
06283727893 |
| Fax |
|
| Email |
charviraheja75@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Charvi Raheja |
| Designation |
Post Graduate |
| Affiliation |
Dr. Harvansh Singh Judge Institute of Dental Sciences and Hospital, Chandigarh |
| Address |
Room no. 108
Dr. Harvansh Singh Judge Institute of Dental Sciences and Hospital, Chandigarh, PU, Sector 25
Chandigarh
CHANDIGARH
160014
India |
| Phone |
06283727893 |
| Fax |
|
| Email |
charviraheja75@gmail.com |
|
|
Source of Monetary or Material Support
|
| NILDr. Harvansh Singh Judge Institute of Dental Sciences and Hospital, Chandigarh, Sector 25, INDIA, 160014 |
|
|
Primary Sponsor
|
| Name |
Dr Charvi Raheja |
| Address |
Dr. Harvansh Singh Judge Institute of dental sciences and hospital punjab university chandigarh. Sector 25, INDIA.
160014 |
| 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 |
| Dr Charvi Raheja |
Dr. Harvansh Singh Judge Institute of Dental Sciences and Hospital, Chandigarh |
Room No. 108, Department of Periodontics, Sector 25
Chandigarh
CHANDIGARH |
06283727893
charviraheja75@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Punjab University Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
PERIODONTITIS |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
GROUP A = VISTA + Platelet Rich FIbrin |
A single 8–10 mm vertical vestibular incision will be made, and a subperiosteal tunnel flap will be created extending 1 cm beyond recession sites while preserving papillae. Platelet Rich Fibrin will be placed within the tunnel. Horizontal coronal sutures secured with composite will stabilize the flap. Procedures will be performed using the VISTA kit, with follow-up at 3 and 6 months. |
| Comparator Agent |
GROUP B = VISTA + Amniotic Membrane |
A single 8–10 mm vertical vestibular incision will be made, and a subperiosteal tunnel flap will be created extending 1 cm beyond recession sites while preserving papillae. Amniotic Membrane will be placed within the tunnel. Horizontal coronal sutures secured with composite will stabilize the flap. Procedures will be performed using the VISTA kit, with follow-up at 3 and 6 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
INCLUSION CRITERIA:
1. Multiple adjacent gingival recession Miller type I/II
2. The participants who are systemically healthy with good oral hygiene
3. Aged from 18–50 years |
|
| ExclusionCriteria |
| Details |
EXCLUSION CRITERIA:
1. Systemic diseases interrupting the healing after surgical procedures
2. Patients who showed improper oral hygiene
3. Patients with Trauma from Occlusion
4. Smoking, and alcohol consumption
5. Patients with allergy to the Membrane used in the current study
6. Patients with cervical restoration in the facial surface of the involved tooth
7. Patients with high frenal pull
8. Patients received a periodontal surgery at the same location of designed
treatment of gingival recession in the in the past 1 year. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary outcomes of the study:
1. GRD – gingival recession depth,
2. KGW – keratinized gingival width
3. RC% – mean percent of root coverage
4. GTH - gingival thickness
5. To examine the volumetric changes in soft tissue aspects following root
coverage using 3D Scan |
Baseline, 3 months, 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary outcomes of the study
1. PPD - probing pocket depth
2. CAL – clinical attachment level |
Baseline, 3 months, 6 months |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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)
|
31/01/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
31/01/2026 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
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
|
Patients will be recruited based on inclusion and exclusion criteria and explained about the nature of study, the outcomes of it, followed by which a verbal and written consent will be obtained and randomly divided into 2 groups. At baseline clinical parameters and 3D Scans will be obtained followed by SRP and Vestibular Incision Subperiosteal Tunnel Access Technique and graft will be added based on assigned groups. Post Op instructions will be given. Suture Removal done after 3 weeks.
Patients will be followed up after 3 and 6 months post op. |