| CTRI Number |
CTRI/2022/11/047450 [Registered on: 21/11/2022] Trial Registered Prospectively |
| Last Modified On: |
17/11/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparison of 2 different biological materials for the treatment of receding gums with VISTA technique |
|
Scientific Title of Study
|
A comparative evaluation of vestibular incision subperiosteal tunnel access technique with platelet-rich fibrin vs amnion membrane in the treatment of gingival recession - A single-blinded parallel arm randomized clinical trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Hoshang Advani |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences, Rishikesh |
| Address |
AIIMS barrage road, Veerbhadra Marg, Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
8440070700 |
| Fax |
|
| Email |
hoshangadvani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashutosh Dixit |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences, Rishikesh |
| Address |
AIIMS barrage road, Veerbhadra Marg, Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9899818242 |
| Fax |
|
| Email |
dixitdrashutosh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Hoshang Advani |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences, Rishikesh |
| Address |
AIIMS barrage road, Veerbhadra Marg, Rishikesh
UTTARANCHAL
249203
India |
| Phone |
8440070700 |
| Fax |
|
| Email |
hoshangadvani@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dept of Dentistry, AIIMS barrage road, veerbhadra marg, Rishikesh |
|
|
Primary Sponsor
|
| Name |
Hoshang Advani |
| Address |
AIIMS barrage road, Veerbhadra marg, Rishikesh |
| 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 |
| Hoshang Advani |
Dept. of Dentistry, AIIMS, Rishikesh |
AIIMS barrage road, veerbhadra marg, Rishikesh
Dehradun
UTTARANCHAL |
8440070700
hoshangadvani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, AIIMS, Rishikesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Systemically healthy volunteers presenting with Cairos RT 1 gingival recession on atleast 2 teeth |
| Patients |
(1) ICD-10 Condition: K060||Gingival recession, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Platelet Rich Fibrin |
Platelet-rich fibrin is an autologous graft material prepared from patients own blood that is rich in various growth factors that can be used to cover gingival recession defects. At the time of surgery, it will be placed for gingival coverage. |
| Intervention |
Processed amnion membrane graft |
Amnion membrane is an allograft which is rich source of various growth factors that can be used in the treatment of covering gingival recession defects after processing and sterilization. At the time of surgery, it will be placed for gingival coverage. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Systemically healthy patients with Cairos RT1 gingival recession on atleast 2 teeth and sufficient vestibular depth and attached gingiva. |
|
| ExclusionCriteria |
| Details |
1. Patients with any systemic/compromising medical condition.
2. Patients with non-vital teeth.
3. Patients on immunosuppressant drugs, or drugs known to cause gingival enlargement.
4. Patients with active infections.
5. Patients with abnormal bleeding, clotting, prothrombin time
6. Patients having high frenal attachment.
7. Pregnant and lactating females.
8. Smokers.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Recession height
Recession width
Pocket probing depth |
Baseline
1 month
3 months
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Width of keratinized gingiva
Relative attachment level
Mean root coverage
|
baseline
1 month
3 month
6 month |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
22/11/2022 |
| 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
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [hoshangadvani@gmail.com].
- For how long will this data be available start date provided 01-02-2025 and end date provided 01-02-2027?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
The study aims to compare the effectiveness of the minimally invasive Vestibular Incision Subperiosteal Tunnel Access (VISTA) technique either with amnion membrane or platelet-rich fibrin (PRF) for the treatment of Cairo’s RT 1 gingival recession defects.
The primary objective of the study is to assess the change in aesthetic Root coverage which is done by measuring - Recession Height (RH), Recession Width (RW), and Pocket Probing depth (PPD) following treatment of Gingival recession by VISTA with PRF or Amnion membrane (AM). The secondary objective is to assess the change in the following parameters following intervention for gingival recession: 1. Width of keratinized gingiva 2. Relative attachment level 3. Mean root coverage |