| CTRI Number |
CTRI/2025/01/078938 [Registered on: 17/01/2025] Trial Registered Prospectively |
| Last Modified On: |
02/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Treatment of exposed teeth with platelet concentrates along with antibiotics. |
|
Scientific Title of Study
|
Efficacy of the use of PRF membrane with or without antibiotic incorporation as an adjunct to coronally advanced flap in the treatment of gingival recession. |
| 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 Alapan Banerjee |
| Designation |
Post graduate student |
| Affiliation |
Institute of Dental Studies and Technologies |
| Address |
DEPARTMENT OF PERIODONTOLOGY INSTITUTE OF DENTAL STUDIES AND TECHNOLOGIES NH 58 DELHI MEERUT ROAD KADRABAD MODINAGAR
GHAZIABAD UTTAR PRADESH 201201 INDIA
Ghaziabad
UTTAR PRADESH
201201
India |
| Phone |
8660306739 |
| Fax |
|
| Email |
alapanbanerjee360@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mansi Bansal |
| Designation |
Professor and Head |
| Affiliation |
Institute of Dental Studies and Technologies |
| Address |
DEPARTMENT OF PERIODONTOLOGY INSTITUTE OF DENTAL STUDIES AND TECHNOLOGIES NH 58 DELHI MEERUT ROAD KADRABAD MODINAGAR
GHAZIABAD UTTAR PRADESH 201201 INDIA
Ghaziabad
UTTAR PRADESH
201201
India |
| Phone |
9871655313 |
| Fax |
|
| Email |
drmansibansal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sakshi Gaind |
| Designation |
Senior Lecturer |
| Affiliation |
Institute of Dental Studies and Technologies |
| Address |
DEPARTMENT OF PERIODONTOLOGY INSTITUTE OF DENTAL STUDIES AND TECHNOLOGIES NH 58 DELHI MEERUT ROAD KADRABAD MODINAGAR
GHAZIABAD UTTAR PRADESH 201201 INDIA
Ghaziabad
UTTAR PRADESH
201201
India |
| Phone |
9871655313 |
| Fax |
|
| Email |
sakshigaind@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Periodontology, Institute of Dental Studies and Technologies, NH-58,
Delhi-Meerut Road, Kadrabad, Modinagar Ghaziabad UTTAR PRADESH 201201 India |
|
|
Primary Sponsor
|
| Name |
Institute of Dental Studies & Technologies |
| Address |
Institute of Dental Studies & Technologies, NH-58, Delhi-Meerut
Road, Kadrabad, Modinagar, Uttar Pradesh, India-201201 |
| Type of Sponsor |
Research institution |
|
|
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 Alapan Banerjee |
Institute of Dental Studies & Technologies |
Institute of Dental
Studies and Technologi
es,Department of
Periodontology, Room
number 7, NH-58,
Delhi-Meerut Road,
Kadrabad, Modinagar,
Uttar Pradesh,
India-201201
Ghaziabad
UTTAR PRADESH |
8660306739
alapanbanerjee1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IDST ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K05||Gingivitis and periodontal diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Antibiotic incorporated PRF Membrane |
As an optimized, natural blood
clot, PRF is a complex
biomaterial with a specific
biology. after reflection of the
coronal fap, prf membrane is
sutured on the recession
defect.PRF membrane will be
prepared by taking 10 ml of
patients blood from median
cubital vein in a 10 ml vacutainer without
anticoagulant and in it 0.5 ml of Metronidazole is added followed by
centrifugation at 2700 rpm for
12 min. Out of three different
layers obtained on
centrifugation, middle layer of
fibrin clot will be taken out with
the help of a tweezer and a PRF
membrane will be prepared
from it by squeezing it between
two pieces of moist sterile
gauze. The clinical parameters
will be evaluated at baseline, 3
months and 6 months. |
| Intervention |
PRF membrane |
As an optimized, natural blood
clot, PRF is a complex
biomaterial with a specific
biology. after reflection of the
coronal fap, prf membrane is
sutured on the recession
defect.PRF membrane will be
prepared by taking 10 ml of
patients blood from median
cubital vein in a 10 ml vacutainer without
anticoagulant, followed by
centrifugation at 2700 rpm for
12 min. Out of three different
layers obtained on
centrifugation, middle layer of
fibrin clot will be taken out with
the help of a tweezer and a PRF
membrane will be prepared
from it by squeezing it between
two pieces of moist sterile
gauze. The clinical parameters
will be evaluated at baseline, 3
months and 6 months. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Systematically healthy patients and patients having minimum two bilateral Cairo RT1/RT2 gingival recession defect. |
|
| ExclusionCriteria |
| Details |
Severe cervical abrasions or root caries requiring restoration
Aberrant frenal attachment
Malpositioned teeth
Smokers
Pregnant or lactating females
Patients having undergone any periodontal therapy in the last six
months.
Antibiotic therapy in past 6 months.
Clotting and hematological disorders. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
With the use of stent-
Probing Pocket Depth (PPD): [(FRP-BOP) -(FRP-GM)]
Clinical Attachment Level (CAL): [(FRP-BOP)- (FRP-CEJ)]
Gingival Recession (GR): [(FRP-GM)-(FRP-CEJ)]
Width of Keratinized Gingiva (KT): [(FRP-MGJ)-(FRP-GM)]
Without the use of stent-
1.Width of Recession (At CEJ) |
Baseline, 12 weeks and 24 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Root Coverage Esthetic Score (RES) and
percentage of Root Coverage. |
6 MONTHS |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "10"
Final Enrollment numbers achieved (India)="10" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/01/2025 |
| Date of Study Completion (India) |
18/11/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
| This study was conducted and compiled by Dr. Alapan Banerjee, Dr. Mansi Bansal, Dr. Manish Khatri, Mohd. Rehan , Dr Narendra, Dr Sakshi Gaind, Dr Pratiksha tripathi at Department Of Periodontology, Institute of Dental Studies and | | Technologies, Kadrabad, Modinagar, Uttar Pradesh, IndiaThe study is a randomized control trial for comparison of the use of PRF membrane with or without antibiotic incorporation with coronally advanced flap in treatment of gingival recession |
|