| CTRI Number |
CTRI/2019/06/019942 [Registered on: 28/06/2019] Trial Registered Prospectively |
| Last Modified On: |
05/11/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Gum coverage treatment |
|
Scientific Title of Study
|
Evaluation of clinical efficacy of Advanced platelet rich fibrin(A-PRF)in the management of gingival recession defects-A prospective 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 swapna chekurthy |
| Designation |
Post graduate |
| Affiliation |
SRM Dental college. |
| Address |
SRM Dental college,
Dept of periodontology,
4th floor,PG division,
Bharathi salai,
Ramapuram,
Chennai-600089
Chennai
TAMIL NADU
600089
India |
| Phone |
9884131309 |
| Fax |
|
| Email |
swapnach78@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anupama tadepalli |
| Designation |
Reader |
| Affiliation |
SRM dental college |
| Address |
SRM Dental college,
Department of periodontology,
4th floor,PG division,
Bharathi salai,
Ramapuram,
Chennai-600089
Chennai
TAMIL NADU
600089
India |
| Phone |
9677065517 |
| Fax |
|
| Email |
anupamamds@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anupama tadepalli |
| Designation |
Reader |
| Affiliation |
SRM dental college |
| Address |
SRM Dental college,
Department of periodontology,
4th floor,PG division
Bharathi salai,
Ramapuram,
Chennai-600089
Chennai
TAMIL NADU
600089
India |
| Phone |
9677065517 |
| Fax |
|
| Email |
anupamamds@gmail.com |
|
|
Source of Monetary or Material Support
|
| Self- funded
Dr Swapna Chekurthy
SRM Dental College,
Department of Periodontics,
4th floor,PG division,
Ramapuram campus,
Bharathi salai,
Chennai-600089,
Tamilnadu. |
|
|
Primary Sponsor
|
| Name |
Dr Swapna chekurthy |
| Address |
SRM Dental college,
Dept of periodontology,
Bharathi salai,
Ramapuram,
Chennai-600089
|
| Type of Sponsor |
Other [self- funded swapna chekurthy] |
|
|
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 |
| Swapna chekurthy |
SRM DENTAL COLLEGE. |
Departmant of Periodontics,
4th floor,PG division,
Ramapuram campus,
Bharathi salai,
Chennai-600089
Chennai
TAMIL NADU |
9884131309
swapnach78@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL REVIEW BOARD |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Presenting with gingival recession |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with millers class I and II recession defects in maxillary anteriors and premolars
2.Minimum recession height ≥ 2mm
3.Systematically healthy patients
|
|
| ExclusionCriteria |
| Details |
1.Millers class III and 1V gingival recession
2.Recession sites with probing depth ≥ 4mm and
mobile teeth
3.Teeth with prosthetic restorations
4.Teeth with traumatic occlusion
5.Anaemic patients
6. Patients with platelet disorders
7.Smokers
8.Pregnant and lactating women
9.Patients with poor oral hygiene
10.Systemic condition /disease/any medication
influencing the periodontal therapy and disease
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Recession height
2.Root coverage % |
Baseline,6 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1.Width of attached gingiva. |
Baseline, 6 months. |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="35" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/07/2019 |
| Date of Study Completion (India) |
01/10/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Gingival recession is a common periodontal manifestation resulting in esthetic deformity and often associated with dentinal hypersensitivity. L-PRF is being widely studied in various dental procedures and its application in gingival recession defects is well documented. The recent modification of conventional PRF is the advanced platelet rich fibrin (A-PRF). Its efficacy is not been evaluated much in management of gingival recession. The current study proposes to assess clinical outcomes following the use of advanced platelet rich fibrin in management of gingival recession defects. |