| CTRI Number |
CTRI/2025/02/080320 [Registered on: 11/02/2025] Trial Registered Prospectively |
| Last Modified On: |
20/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing injectable platelet rich fibrin and Advanced platelet rich fibrin with injectable platelet rich fibrin and Pericardial membrane using Gum drop technique in treating Gingival Recessions |
|
Scientific Title of Study
|
A COMPARATIVE EVALUATION OF GUM DROP TECHNIQUE USING PLATELET CONCENTRATES Vs PERICARDIAL MEMBRANE WITH INJECTABLE PLATELET RICH FIBRIN IN CLASS I AND CLASS II GINGIVAL RECESSIONS-A PARALLEL ARM 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 K REKHA RANI |
| Designation |
HEAD OF THE DEPARTMENT |
| Affiliation |
Panineeya Mahavidyala Institute of Dental sciences and research centre |
| Address |
Room no 101,Department of periodontics,panineeya Mahavidalaya institute of denal sciences and research centre,road no 5,kamalanagar Dilsukhnagar,Hyderabad.
Hyderabad
TELANGANA
500060
India |
| Phone |
9885160094 |
| Fax |
|
| Email |
rekhasarat2304@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K REKHA RANI |
| Designation |
HEAD OF THE DEPARTMENT |
| Affiliation |
Panineeya Mahavidyala Institute of Dental sciences and research centre |
| Address |
Room no 101,Department of periodontics,panineeya Mahavidalaya institute of denal sciences and research centre,road no 5,kamalanagar Dilsukhnagar,Hyderabad.
Hyderabad
TELANGANA
500060
India |
| Phone |
9885160094 |
| Fax |
|
| Email |
rekhasarat2304@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
G SHIVANI |
| Designation |
Post Graduate |
| Affiliation |
Panineeya Mahavidyala Institute of Dental sciences and research centre |
| Address |
Room no 101,Department of periodontics,panineeya Mahavidalaya institute of denal sciences and research centre,road no 5,kamalanagar Dilsukhnagar,Hyderabad.
Hyderabad
TELANGANA
500060
India |
| Phone |
9032000279 |
| Fax |
|
| Email |
shivani.dimple1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Panineeya Mahavidyalaya Institute of Dental Sciences and research centre Road no 5 Kamala nagar Dilshuknagar Hyderabad Telangana 500065 India |
|
|
Primary Sponsor
|
| Name |
Panineeya Mahavidyalaya Institute of Dental Sciences and research centre |
| Address |
Road no 5 Kamala nagar Dilshuknagar Hyderabad Telangana 500065 India |
| 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 G SHIVANI |
Panineeya Mahavidyalaya Institute of Dental Sciences and research centre |
Room no 101 Department of periodontics Road no 5 Kamala nagar Dilshuknagar Hyderabad Telangana 500065 India
Hyderabad
TELANGANA |
9032000279
shivani.dimple1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Communication of Decision of the Institutional Ethics Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group 1 -7 i-PRF+ A-PRF Using Gum drop Technique in class I AND CLASS II Gingival recessions |
6 MONTHS
|
| Comparator Agent |
Group 2-7 i-PRF+Pericardial Membrane using Gum drop Technique in class I AND CLASS II Gingival recessions |
6 MONTHS |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient aged more than 20 years with class I and class II gingival recessions.
2.Patients having recession of one tooth or multiple teeth in maxilla or mandible.
3.The Keratinized tissue width(KTW) should be more than 2mm.
|
|
| ExclusionCriteria |
| Details |
1.Any systemic disease that contraindicates periodontal surgery or may affect healing.
2.Current smokers
3.Pregnant and lactating mothers.
4.History of intake of antibiotics or other medications affecting the periodontium in the previous 6 months.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Recession Height(RH)
Recession width(RW)
Keratinized tissue width(KTW)
|
BASE LINE,3 MONTHS AND 6 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Probing pocket depth(PPD)
Clinical attachment level(CAL) |
BASE LINE,3 MONTHS AND 6 MONTHS |
|
|
Target Sample Size
|
Total Sample Size="14"
Sample Size from India="14"
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 4 |
|
Date of First Enrollment (India)
|
21/02/2025 |
| 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="6"
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
|
| To overcome problems associated with conventional periodontal surgery such as loss of tooth supporting tissue including papillae, along with associated postoperative pain,bleeding, swelling, root hypersensitivity and delayed healing, several minimally invasive techniques have been employed.
| GUM DROP TECHNIQUE- is a papilla preservation technique, with a less invasive surgical approach utilizing platelet rich fibrin PRF as the graft material with improved treatment outcomes .It is an alternative to the conventional treatments for gingival recession coverage INJECTABLE PLATELET-RICH FIBRIN I-PRF is a liquid autologous platelet concentrate created by low-speed centrifugation at 700rpm for 3 min, omitting the formation of a PRF membrane. It harbors a variety of growth and differentiation factor, promotes angiogenesis, traps circulating stemcells, induces collagen synthesis, and stimulates the growth of fibroblasts and osteoblasts as well as prolongs the delivery of growth factors to the area where a wound is present. ADVANCED PLATELET RICH FIBRIN A-PRF The fibrin clot that is derived from the centrifuged blood at 1300 rpm for 14 min becomes a membrane that can be used in place of autogenous connective tissue or acellular membranes in various procedures. PERICARDIUM MEMBRANE - The pericardium membrane is derived from natural pericardium which has got a specific tridimensional structure with preserved links between collagen fibers and elastin. The pericardial membrane has got good biocompatibility and handling property with slow degradation rate. The source of this membrane could be bovine or porcine, with bovine membranes showing superior results. | |
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