| CTRI Number |
CTRI/2017/05/008479 [Registered on: 04/05/2017] Trial Registered Prospectively |
| Last Modified On: |
20/12/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To compare the results for covering exposed tooth surface by using synthetic membrane in one group and a membrane made from patients extracted blood in another |
|
Scientific Title of Study
|
A Comparative analysis of double membrane platelet rich fibrin and acellular dermal matrix allograft using modified coronally repositioned flap in single tooth recession |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kriti Arora |
| Designation |
Post-graduate student |
| Affiliation |
manipal college of dental sciences |
| Address |
department of periodontology
manipal college of dental sciences
manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9999321764 |
| Fax |
|
| Email |
kriti194@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr G Subraya Bhat |
| Designation |
Associate dean and professor |
| Affiliation |
manipal college of dental sciences |
| Address |
department of periodontology
manipal college of dental sciences
manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9632170341 |
| Fax |
|
| Email |
subraya.bhat@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr G Subraya Bhat |
| Designation |
Associate dean and professor |
| Affiliation |
manipal college of dental sciences |
| Address |
department of periodontology
manipal college of dental sciences
manipal
department of periodontology
manipal college of dental sciences
manipal
KARNATAKA
576104
India |
| Phone |
9632170341 |
| Fax |
|
| Email |
subraya.bhat@manipal.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr B Aravinda |
| Address |
15640 Redmond way
Redmond
WA 98052
|
| 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 |
| Kriti Arora |
Manipal college of dental sciences,manipal |
department number 3 , periodontology
Udupi
KARNATAKA |
9999321764
kriti194@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KMC and KH Institution Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients coming to the department of periodontology who have 3-4 mm gingival recession and need root coverage., |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Alloderm |
It is acellular dermal matrix available commercially. |
| Intervention |
Platelet rich fibrin( double membrane) |
This membrane will be prepared in office from patients own blood. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Subjects with Miller’s class I and class II gingival recession who are systemically healthy. |
|
| ExclusionCriteria |
| Details |
1.Subjects with Miller’s class III and class IV gingival recession.
2.Subject with abusive habits such as smoking or those who are pregnant or lactating and any other systemic diseases
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Root coverage |
3 months and 6 months from the day of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Gingival esthetic index, gingival index,plaque index,probing pocket depth,clinical attachment level,width of attached gingiva,height and width of ginigval recession,height of keratinized gingiva |
on the day of surgery and after 3 months and 6 months from surgery |
|
|
Target Sample Size
|
Total Sample Size="12"
Sample Size from India="12"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/05/2017 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
not as yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
For root coverage procedures, connective tissue graft is considered to be gold standard but
complications such as exposure of second surgical site, trauma and possibility of bleeding
remain its complications. Acellular Dermal Matrix is a human dermis derived product which has
overcome these problems however cost factor is a drawback.Post surgically because of the
thickness of both the grafts(connective tissue graft and Acellular Dermal Matrix) further
correction of contour is required. Newly introduced and advocated double membrane Platelet
Rich Fibrin is expected to overcome the shortcomings of other commonly used materials for
root coverage. Present study aims to evaluate the clinical efficacy of double membrane PRF and
Alloderm in single tooth recession |