| CTRI Number |
CTRI/2018/02/011790 [Registered on: 09/02/2018] Trial Registered Retrospectively |
| Last Modified On: |
23/05/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Tooth covering assessment using blood derived and yolk sac membrane |
|
Scientific Title of Study
|
Root coverage with amniotic membrane and platelet rich fibrin in millers class I or class II gingival recession :A randomized clinical study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
RavithejBorugadda |
| Designation |
Post Graduate Trainee |
| Affiliation |
Sibar institute of dental sciences |
| Address |
Department of periodontology and implantology
Takellapadu
Guntur
ANDHRA PRADESH
5222509
India |
| Phone |
09989337764 |
| Fax |
08632292139 |
| Email |
ravitej.borugadda@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Srinivas Moogla |
| Designation |
Professor |
| Affiliation |
sibar institute of dental sciences |
| Address |
Department of periodontology and implantology
Takellapadu
Guntur
ANDHRA PRADESH
5222509
India |
| Phone |
09849027700 |
| Fax |
08632292139 |
| Email |
srinumoogla@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vivekanand Kattimani |
| Designation |
Associate Professor |
| Affiliation |
sibar institute of dental sciences |
| Address |
Department of oral and maxillofacial surgery
Takellapadu
Guntur
ANDHRA PRADESH
5222509
India |
| Phone |
09912400988 |
| Fax |
08632292139 |
| Email |
drvivekanandsk@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. L Krishna Prasad, Prinicpal, SIBAR institute of dental sciences, Takkellapadu, Pedakakani Guntur 522509 |
|
|
Primary Sponsor
|
| Name |
Dr Ravithej Borugadda |
| Address |
Post graduate Trainee , Room-8, Floor 2, Department of Periodontology & Implantology
SIBAR Institute of Dental Sciences, Takkellapadu, Guntur 522509 |
| Type of Sponsor |
Other [Private Dental college 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 Ravithej Borugadda |
Department of Periodontology and implantology |
Floor 2, Room no-8, SIBAR Institute of Dental Sciences, Takkellapadu, Pedakakani
Guntur
ANDHRA PRADESH |
9989337764
08632292139
ravitej.borugadda@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Isolated Gingival recession in relation anteriors and premolars of both jaws. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
amniotic membrane |
A commercially available amniotic membrane of 2x2 cm. |
| Intervention |
PRF in root coverage |
PRF is secured from patients own blood by centrifuging 3000 rpm for 3 min. 6 months duration of follow up. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Willing for the participation in the study with millers class I or class II gingival recession. |
|
| ExclusionCriteria |
| Details |
Immuno-compromised patients
Multiple recession.
Millers class III and class IV gingival recession
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Compare the amount of root coverage in gingival recession |
At baseline, 3 months, 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the improvement in clinical parameters |
At baseline, 3 months, 6 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
24/05/2015 |
| 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="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
yet to be published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is randomized, comparative, double blinded clinical trial which includes 30 patients both male/female of age between 20 to 50 years with Miller’s class I or II gingival recession and are divided into two groups : Group A : Root coverage using Amniotic membrane Group B : root coverage using Platelet rich fibrin Post operative evaluation will be done at baseline, 3 months and 6 months, to compare the amount
of root coverage and improvement in clinical parameters.
|