| CTRI Number |
CTRI/2018/03/012377 [Registered on: 06/03/2018] Trial Registered Retrospectively |
| Last Modified On: |
27/02/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Advanced platelet Rich Fibrin and Injectable Platelet Rich Fibrin for the treatment of Gingival Recessions |
|
Scientific Title of Study
|
Comparative evaluation of Advanced platelet Rich Fibrin and Injectable Platelet Rich Fibrin for the treatment of Millers class I and class II Gingival Recessions |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jillela Asha latha |
| Designation |
Post Graduate in Periodontics |
| Affiliation |
ST Joseph dental college |
| Address |
J Asha latha ,
ST Joseph dental college, Duggirala,
Eluru- 534003, Andhra Pradesh.
West Godavari
ANDHRA PRADESH
534003
India |
| Phone |
9010773094 |
| Fax |
|
| Email |
ashajillella@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
MNaga sri |
| Designation |
Professor |
| Affiliation |
ST Joseph dental college |
| Address |
ST Joseph dental college, Duggirala, Eluru- 534003, Andhra Pradesh.
West Godavari
ANDHRA PRADESH
534003
India |
| Phone |
8297667304 |
| Fax |
|
| Email |
nagasri.vij@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jillela Asha latha |
| Designation |
Post Graduate in Periodontics |
| Affiliation |
ST Joseph dental college |
| Address |
ST Joseph dental college, Duggirala, Eluru- 534003 ANDHRA PRADESH.
West Godavari
ANDHRA PRADESH
534003
India |
| Phone |
9010773094 |
| Fax |
|
| Email |
ashajillella@gmail.com |
|
|
Source of Monetary or Material Support
|
| ST Joseph dental college,
Duggirala, Eluru-534003,
Andhra Pradesh |
|
|
Primary Sponsor
|
| Name |
JAsha latha |
| Address |
ST Joseph dental college,
Duggirala,
Eluru-534003, Andhra Pradesh. |
| 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 |
| Jillela Asha Latha |
St Joseph dental college |
Department of periodontics,
ST Joseph dental college,
Duggirala,Eluru-534003
West Godavari
ANDHRA PRADESH |
9010773094
ashajillella@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| institutional ethical commitee st joseph dental college eluru |
Approved |
| Institutional Ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
class 1 gingival recessions, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
APRF AND IPRF |
APRF AND IPRF |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
patients who are willing to take part in the study
patients with millers class 1 and 2 gingival recessions |
|
| ExclusionCriteria |
| Details |
patients with habits of smoking,alcohol consumption,pregnant women,crowding |
|
|
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 |
| The primary outcome of the study is to compare and evaluate Advanced Platelet Rich Fibrin and Injectable platelet rich fibrin in treatment of bilateral gingival recessions Millers class 1 or 2 |
The primary outcome of the study is to compare and evaluate Advanced Platelet Rich Fibrin and Injectable platelet rich fibrin in treatment of bilateral gingival recessions Millers class 1 or 2 at baseline,3 months and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The outcome of the study is to compare and evaluate Advanced Platelet Rich Fibrin and Injectable platelet rich fibrin in treatment of bilateral gingival recessions Millers class 1 or 2 |
0 TO 6 MONTHS |
|
|
Target Sample Size
|
Total Sample Size="12"
Sample Size from India="12"
Final Enrollment numbers achieved (Total)= "12"
Final Enrollment numbers achieved (India)="12" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
12/05/2015 |
| Date of Study Completion (India) |
30/09/2017 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Gingival recession is the exposure of root surface when the gingival margin is apically located to the cemento enamel junction. Many treatment modalities have been used in treating gingival recession, among these platelet rich fibrin is one of them. Adavnced Platelet rich fibrin (A-PRF) is rich in monocytes which helps in more and early vascularization,faster soft tissue growth,release of BMP’s and cytokines than standard PRF.I-PRF is a liquid form of PRF which is injectable and coagulates immediately after injection . The purpose of this study is to compare and evaluate Advanced Platelet Rich Fibrin(A-PRF) and Injectable platelet rich fibrin (I-PRF) in treatment of bilateral gingival recessions (Millers class 1 or 2). Twelve patients with Miller’s class I and class II gingival recessions of age group 18-45years who were non smokers, and who presented with good general health were enrolled in the study . Each patient will be randomly treated with A-PRF and I-PRF. Various periodontal parameters and the percentage of root coverage and amount of regeneration will be compared at baseline, 3 months and after 6 months |