| CTRI Number |
CTRI/2020/03/024095 [Registered on: 20/03/2020] Trial Registered Prospectively |
| Last Modified On: |
11/03/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
COMPARATIVE CLINICAL EVALUATION OF CORONALLY ADVANCED FLAP WITH OR WITHOUT PLATELET RICH FIBRIN IN THE TREATMENT OF ISOLATED GINGIVAL RECESSION |
|
Scientific Title of Study
|
COMPARATIVE CLINICAL EVALUATION OF CORONALLY ADVANCED FLAP WITH OR WITHOUT PLATELET RICH FIBRIN IN THE TREATMENT OF ISOLATED GINGIVAL RECESSION |
| Trial Acronym |
CAFPRF |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Monisha Kaushik |
| Designation |
MDS SECOND YEAR |
| Affiliation |
SHREE BANKEY BIHARI DENTAL COLLEGE & RESEARCH CENTRE |
| Address |
Delhi Hapur Road 0.5 km ahead of Masuri Canal
Masuri
Ghaziabad
UTTAR PRADESH
201302
India |
| Phone |
07529987587 |
| Fax |
|
| Email |
monishakaus24@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Monisha Kaushik |
| Designation |
MDS SECOND YEAR |
| Affiliation |
SHREE BANKEY BIHARI DENTAL COLLEGE & RESEARCH CENTRE |
| Address |
Delhi Hapur Road 0.5 km ahead of Masuri Canal
Masuri
Ghaziabad
UTTAR PRADESH
201302
India |
| Phone |
07529987587 |
| Fax |
|
| Email |
monishakaus24@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Monisha Kaushik |
| Designation |
MDS SECOND YEAR |
| Affiliation |
SHREE BANKEY BIHARI DENTAL COLLEGE & RESEARCH CENTRE |
| Address |
Delhi Hapur Road 0.5 km ahead of Masuri Canal
Masuri
Ghaziabad
UTTAR PRADESH
201302
India |
| Phone |
07529987587 |
| Fax |
|
| Email |
monishakaus24@gmail.com |
|
|
Source of Monetary or Material Support
|
| SHREE BANKEY BIHARI DENTAL COLLEGE & RESEARCH CENTRE
Delhi-Hapur Road, Masuri, Ghaziabad
|
|
|
Primary Sponsor
|
| Name |
SHREE BANKEY BIHARI DENTAL COLLEGE RESEARCH CENTRE |
| Address |
Delhi-Hapur Road, Masuri, Ghaziabad 201302 |
| Type of Sponsor |
Private medical college |
|
|
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 Neha Gupta |
DEPARTMENT OF PERIODONTICS, SHREE BANKEY BIHARI DENTAL COLLEGE & RESEARCH CENTRE |
Delhi-Hapur Road, Masuri, Ghaziabad 201302
Ghaziabad
UTTAR PRADESH |
9971581158
nehajalaj@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICAL COMMITTEE SHREE BANKEY BIHARI DENTAL COLLEGE & RESEARCH CENTRE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K060||Gingival recession, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Platelet Rich Fibrin |
CORONALLY ADVANCED FLAP WITH OR WITHOUT PLATELET RICH FIBRIN |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. 14 patients either female or male in the age group of 18-60 years.
2. Presence of Miller’s class I or II recession defect.
3. Patients willing to participate in the study with approval in written consent form.
|
|
| ExclusionCriteria |
| Details |
1. Systemic illness known to affect the outcome of periodontal therapy.
2. Allergic to medications.
3. Pregnant and lactating women.
4. Use of tobacco in any form.
5. Patients with caries or restorations in the area to be treated.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Width of Keratinized Tissue, Recession Depth, Clinical Attachment Level, Recession Width |
1ST, 3RD AND 6TH MONTH |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Plaque index, % of root coverage |
1ST, 3RD AND 6TH MONTH |
|
|
Target Sample Size
|
Total Sample Size="14"
Sample Size from India="14"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
23/03/2020 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
14 patients including both female or male in the
age range between 18-60 yrs are to be considered. Patients will be randomly
selected from out patient of the department of Periodontology at Shree Bankey Bihari Dental College, Hospital
and Research Centre, Ghaziabad ,U.P. having
Miller’s class I or II recession defects. The patients shall be included in the
study after taking their consent & obtaining ethical approval from the
institutional ethical committee. Measurement of clinical parameters, surgical procedure,
as well as PRF preparation will be performed by a single calibrated
investigator. |