| CTRI Number |
CTRI/2021/11/037987 [Registered on: 12/11/2021] Trial Registered Prospectively |
| Last Modified On: |
19/02/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
TREATMENT OF ISOLATED GINGIVAL RECESSION BY GINGIVAL PEDICLE SPLIT THICKNESS TUNNEL TECHNIQUE WITH AND WITHOUT USING I-PRF. |
|
Scientific Title of Study
|
COMPARATIVE EVALUATION OF PDGF-BB LEVELS IN PATIENTS WITH ISOLATED GINGIVAL RECESSION TREATED BY GINGIVAL PEDICLE SPLIT THICKNESS TUNNEL TECHNIQUE WITH AND WITHOUT USING I-PRF:A RANDOMIZED
CONTROLLED TRIAL.
|
| Trial Acronym |
TIGRGPST |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
LEENA PATIL |
| Designation |
POSTGRADUATE |
| Affiliation |
BAPUJI DENTAL COLLEGE AND HOSPITAL, DAVANAGERE |
| Address |
ROOM NO. 5, DEPARTMENT OF PERIODONTICS, BAPUJI DENTAL COLLEGE AND HOSPITAL, DAVANAGERE, KARNATAKA
Davanagere
KARNATAKA
577004
India |
| Phone |
7775812673 |
| Fax |
|
| Email |
leenapatil1295@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR JAYASHEELA M |
| Designation |
PROFESSOR |
| Affiliation |
BAPUJI DENTAL COLLEGE AND HOSPITAL, DAVANAGERE |
| Address |
ROOM NO. 5, DEPARTMENT OF PERIODONTICS, BAPUJI DENTAL COLLEGE AND HOSPITAL, DAVANAGERE, KARNATAKA
Davanagere
KARNATAKA
577004
India |
| Phone |
9986544187 |
| Fax |
|
| Email |
jayasheela6@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
LEENA PATIL |
| Designation |
POSTGRADUATE |
| Affiliation |
BAPUJI DENTAL COLLEGE AND HOSPITAL, DAVANAGERE |
| Address |
ROOM NO. 5, DEPARTMENT OF PERIODONTICS, BAPUJI DENTAL COLLEGE AND HOSPITAL, DAVANAGERE, KARNATAKA
Davanagere
KARNATAKA
577004
India |
| Phone |
7775812673 |
| Fax |
|
| Email |
leenapatil1295@gmail.com |
|
|
Source of Monetary or Material Support
|
| DEPARTMENT OF PERIODONTICS, BAPUJI DENTAL COLLEGE AND HOSPITAL, DAVANAGERE |
|
|
Primary Sponsor
|
| Name |
LEENA PATIL |
| Address |
ROOM NO. 5, DEPARTMENT OF PERIODONTICS,BAPUJI DENTAL COLLEGE AND HOSPITAL DAVANAGERE, KARNATAKA 577004 |
| 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 JAYASHEELA M |
Bapuji Dental College and Hospital, MCC Block , Davanagere 577004 |
Department of Periodontics, Room no.5
Davanagere
KARNATAKA |
9986544187
jayasheela6@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board, Bapuji Dental College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K056||Periodontal disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Deepithelialized free gingival graft |
Deepithelialized free gingival graft will be harvested from the palate according to the recipient bed measurements. |
| Intervention |
I -PRF |
For preparation of I-PRF, 10ml of blood will be drawn and centrifuged at 700 rpm for 3 minutes |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Isolated Gingival recession defects are classified as either Miller’s Class I or II defects.
Subjects who are systemically healthy.
|
|
| ExclusionCriteria |
| Details |
Patients with systemic problems.
Patients who are smokers and tobacco users.
Pregnant and Lactating mothers.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To clinically evaluate and compare clinical parameters in Gingival pedicle split thickness tunnel technique AND deepithelialized gingival graft along with and without using I PRF for the treatment of isolated gingival recession |
change in clinical parameter was calculated at 4 months from baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To biochemically evaluate the PDGF BB levels in Gingival pedicle split thickness tunnel technique and deepithelialized gingival graft along with and without using I PRF for the treatment of isolated gingival recession |
change in clinical parameter was calculated at 4 months from baseline |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "20"
Final Enrollment numbers achieved (India)="20" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
27/12/2021 |
| Date of Study Completion (India) |
25/12/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Gingival
recession is defined as the apical shift of the gingival margin with respect to
the cemento-enamel junction (CEJ), which leads to the exposure of the root
surface. In this comparative study, 20 patients of isolated gingival recession will
be selected randomly based on miller’s classification of gingival recession, 10
in each group.
Each subject will be
given a detailed verbal and written description of the study. Initial
preparation of the recipient site will include a thorough scaling and root planing. After
administration of local anaesthesia Gingival Pedicle Split Thickness (GPST)
technique begins. Deepithelialized free gingival graft will be harvested from
the palate according to the recipient bed measurements. For the preparation of
I-PRF, 10ml of blood will be drawn and centrifuged at 700 rpm for 3 minutes 13,
harvested de-epithelialized free gingival graft will be coated with I-PRF, and
then it will be inserted onto the prepared site and sutured. In the control group, the same procedure will be performed without using I-PRF. Clinical parameters will
be evaluated after 4 months. Comparison of biochemical and clinical findings
will lead to conclusive points.
|