| CTRI Number |
CTRI/2017/04/008349 [Registered on: 13/04/2017] Trial Registered Retrospectively |
| Last Modified On: |
11/04/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of placental membrane and Platelet Rich Fibrin (PRF) for the treatment of root exposure |
|
Scientific Title of Study
|
Comparative evaluation of Coronally Advanced Flap with Bioresorbable membrane or Platelet Rich Fibrin (PRF) membrane in treatment of localised gingival recession: A 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 |
Dr Mohd Rehan |
| Designation |
Ex Post Graduate Student |
| Affiliation |
Institute of Dental Studies and Technologies |
| Address |
Department of Periodontology, Institute of Dental Studies and Technologies, Kadrabad, Modinagar
Ghaziabad
UTTAR PRADESH
201201
India |
| Phone |
9999964474 |
| Fax |
|
| Email |
drrehan2012@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manish Khatri |
| Designation |
Professor & HOD |
| Affiliation |
Institute of Dental Studies and Technologies |
| Address |
Department of Periodontology, Institute of Dental Studies and Technologies, Kadrabad, Modinagar
Ghaziabad
UTTAR PRADESH
201201
India |
| Phone |
9810720335 |
| Fax |
|
| Email |
drmanishkhatri@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mansi Bansal |
| Designation |
Reader |
| Affiliation |
Institute of Dental Studies and Technologies |
| Address |
Department of Periodontology, Institute of Dental Studies and Technologies, Kadrabad, Modinagar
Ghaziabad
UTTAR PRADESH
201201
India |
| Phone |
9871655313 |
| Fax |
|
| Email |
drmansibansal@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Institute of Dental Studies and Technologies |
| Address |
Room no 7,Department of Periodontics, NH-58, Delhi-Meerut Road, Kadrabad, Modinagar, Uttar Pradesh, India-201201 |
| 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 |
| Mohd Rehan |
Institute of Dental Studies and Technologies |
Department of Periodontology,Room no 7, Institute of Dental Studies and Technologies, Modinagar, Uttar Pradesh, India
Ghaziabad
UTTAR PRADESH |
9999964474
drrehan2012@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical Committee of Institute of Dental Studies and Technologies |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
localised gingival recession
(class I & classII), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Amniotic membrane |
Amniotic membrane is a soft tissue allograft composed of multiple layers of dehydrated human amnion tissue processed via Purionâ„¢, a proprietary tissue processing technology that preserves the inherent structure of amnion while cleansing and fusing its layers together.)Membrane was trimmed and placed to cover the bony recession defect extending from the CEJ to cover the adjacent bone mesially, distally, and apically by 2 to 3 millimeters. |
| Comparator Agent |
Platelet Rich fibrin membrane |
Platelet rich fibrin (PRF) is an autologous concentration of platelets in plasma. It is a second generation platelet concentrate widely used to accelerate soft and hard tissue healing.Membrane was trimmed and placed to cover the bony recession defect extending from the CEJ to cover the adjacent bone mesially, distally, and apically by 2 to 3 millimeters. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
The patients will be included if they are systemically healthy and have the presence of at least one Millers Class I or II buccal/ labial recession. |
|
| ExclusionCriteria |
| Details |
Patients will be excluded if they have received any medication known to interact with periodontal treatment during the past six months. Smokers and those with other habits, including the chewing of pan, tobacco, or betel nut, will also be excluded from the study. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Probing Depth, Clinical Attachment Level,Gingival Recession, Width of Keratinized gingiva, Percentage of root coverage
|
Baseline, 6 months, 18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Plaque Index,Gingival Index,
Gingival Bleeding on Probing Index
|
Baseline, 6 months, 18 months |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
14/08/2014 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
not published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study was conducted
and compiled by Dr.Mohd. Rehan, Dr.Manish Khatri, Dr.Mansi Bansal,
Dr.Ashish Kumar and Dr.Komal Puri, at
Department Of Periodontology, Institute of Dental Studies and Technologies,
Modinagar, Uttar Pradesh, India
The
study is a randomized control trial for comparison of the effect of
commercially available amnion membrane and autologous platelet rich fibrin on
the isolated human buccal recession defects.
Assessment and comparison of various parameters was done. |