| CTRI Number |
CTRI/2023/05/053260 [Registered on: 30/05/2023] Trial Registered Prospectively |
| Last Modified On: |
25/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
MANAGEMENT OF GINGIVAL RECESSION WITH OR WITHOUT ALB-PRF USING VISTA |
|
Scientific Title of Study
|
MANAGEMENT OF MILLER’S CLASS I/II GINGIVAL RECESSION WITH OR WITHOUT ALBUMIN PLATELET-RICH FIBRIN (ALB-PRF) USING VESTIBULAR INCISION SUBPERIOSTEAL TUNNEL ACCESS (VISTA)- A RANDOMIZED CONTROLLED TRIAL |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pooja N |
| Designation |
Postgraduate |
| Affiliation |
Bapuji Dental College and Hospital |
| Address |
Department of Periodontics, Bapuji Dental College and Hospital, Davangere
Department of Periodontics, Bapuji Dental College and Hospital, Davangere
Davanagere
KARNATAKA
577004
India |
| Phone |
09550501558 |
| Fax |
|
| Email |
pooja.nagarajan97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Raison Thomas |
| Designation |
Professor |
| Affiliation |
Bapuji Dental College and Hospital |
| Address |
Department of Periodontics, Bapuji Dental College and Hospital, Davangere
Davanagere
KARNATAKA
577004
India |
| Phone |
9886279018 |
| Fax |
|
| Email |
drrais79@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pooja N |
| Designation |
Postgraduate |
| Affiliation |
Bapuji Dental College and Hospital |
| Address |
Department of Periodontics, Bapuji Dental College and Hospital, Davangere
Department of Periodontics, Bapuji Dental College and Hospital, Davangere
KARNATAKA
577004
India |
| Phone |
09550501558 |
| Fax |
|
| Email |
pooja.nagarajan97@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bapuji Dental College and Hospital, Davangere |
|
|
Primary Sponsor
|
| Name |
Dr Pooja N |
| Address |
Department of Periodontics, Bapuji Dental College and Hospital, Davangere. |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Pooja N |
Bapuji Dental College and Hospital |
Room no 5, Department of Periodontics, Bapuji Dental College and Hospital, Davangere
Davanagere
KARNATAKA |
09550501558
pooja.nagarajan97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board, Bapuji Dental College and Hospital, Davangere |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K060||Gingival recession, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Albumin platelet rich fibrin (Alb-PRF) |
To obtain the Alb-PRF, blood collection will be performed using 9 ml S-PRF tube without any additive. After collecting, it will be placed in the centrifuge, along with a tube filled with water in order to maintain the balance during centrifuging for 8 minutes at 2700 rpm. Upon termination of this process, it will be possible to observe plasma and the remaining decanted blood material containing blood cells in the tube. Of this, about 2 ml of the initial portion of plasma (platelet poor plasma [PPP]) will be collected using a syringe, while the rest of the blood contents (buffy coat, portions rich in cells and red blood cells) will be preserved at a cool temperature. The syringe containing platelet poor plasma (PPP) will be heated for 10 minutes at a temperature of 70-75 degree Celsius. After the heating is done, the syringe will be kept at room temperature for another 10 minutes to allow cooling. Then, liquid PRF (i-PRF) including the remaining cells and growth factors found within the buffy coat layer will be mixed back together with the cooled albumin gel to form Alb-PRF using female-female luer lock. The final product after mixing will be deposited into a glass container and will gently be mixed with tweezers. After fibrin polymerization process (approximately 5 minutes), the membrane formed will be termed Alb-PRF. This product will ultimately be used as the graft material in recession coverage. |
| Intervention |
Vestibular Incision Subperiosteal Tunnel Access (VISTA) |
The VITSA technique will start with a single vertical incision of sufficient length. The incision will be extended to the periosteum and to slightly beyond the mucogingival junction. Considering the extension of the teeth to be treated, a vertical incision is to be made in the most centered section. These incisions will be extended to at least one of the teeth beyond those to be treated and towards the base of the papillae. A full-thickness tunnel will then be prepared with the aid of specific tunnelling instruments, extending it sufficiently beyond the mucogingival line into the alveolar mucosa. This will be done first through a vertical incision and then through gingival margins, which will completely release the tunnel-papillae complex, thus facilitating its passive coronal replacement. The graft material that will be placed in the test group will be Alb- PRF. |
|
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Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Miller’s Class I or II gingival recession.
2. Subjects whose Plaque index (PI) score is less than 1.9.
3. Subjects who are systemically healthy.
|
|
| ExclusionCriteria |
| Details |
1. Patients who are smokers (>10 cigarettes/day).
2. Pregnant and Lactating mothers.
3. Patients who are not available for follow up.
4. Patients with crowding of teeth or high frenal attachment.
|
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess percentage of root coverage. |
4 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess root coverage esthetic (RES) score. |
4 months |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
15/06/2023 |
| 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="0"
Months="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
Gingival recession is
defined as the apical shift of the gingival margin with respect to the
cemento-enamel junction, which leads to the exposure of the root surface. The current gold
standard technique is the connective tissue graft with coronally advanced flap.
However, it presents with a number of disadvantages, which include the need for
harvesting at a distant donor site, scar formation at the recipient site,
increased potential for post harvesting morbidity and limited tissue
availability. Platelets play a
vital role in wound healing and release various growth factors. These parameters led
to the development of autologous platelet concentrates such as Platelet-rich
plasma (PRP) followed by Platelet-rich fibrin (PRF) by Choukroun et al. in 2001. However, its major
limitation is its faster resorption (~2 weeks). In a recent study, a novel Alb-PRF was
proposed which demonstrated viable cells which release growth factors over time
while simultaneously improving resorption time from around 2 weeks to 4 months.
Whole blood was centrifuged at 2700 rpm (~ 700×g) for 8 minutes after which the
platelet-poor plasma layer was heated at 75° C for 10 minutes to create
denatured albumin (albumin gel). After heating, the syringe was kept at room
temperature for another 10 minutes to allow cooling. The remaining cells and
growth factor present within the buffy coat layer (liquid PRF) were thereafter
mixed back together with the cooled albumin gel with the help of female-female
luer lock to form Alb-PRF.
|
To our best knowledge, till date no study has been
conducted to assess the efficacy of Alb-PRF as a regenerative material for
root coverage. Hence, the aim of this study is to evaluate and compare the
efficacy of Alb-PRF as a regenerative material for recession coverage with
the help of vestibular incision subperiosteal tunnel access (VISTA)
technique.
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