| CTRI Number |
CTRI/2021/05/033564 [Registered on: 12/05/2021] Trial Registered Prospectively |
| Last Modified On: |
02/08/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Role of two autologous blood derived membranes in management of gum recession |
|
Scientific Title of Study
|
“Comparative evaluation of clinical
efficacy of Leukocyte rich Platelet Rich Fibrin (L-PRF) and
Advanced Platelet Rich Fibrin (A-PRF) in the management of
gingival recession defects-A Randomized controlled trial†|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anupama Tadepalli |
| Designation |
Reader |
| Affiliation |
SRM Dental College |
| Address |
Dr.Anupama Tadepalli, Reader, Department of Periodontics, SRM Dental College, Bharathi Salai, Ramapuram Campus,Chennai
Chennai
TAMIL NADU
600089
India |
| Phone |
9677065517 |
| Fax |
|
| Email |
anupamamds@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anupama Tadepalli |
| Designation |
Reader |
| Affiliation |
SRM Dental College |
| Address |
Dr.Anupama Tadepalli, Reader, Department of Periodontics, SRM Dental College, Bharathi Salai, Ramapuram Campus,Chennai
Dr.Anupama Tadepalli, H 302, Casa Grand Aristo, Nobel 1st Street, No 5, Alandur, Chennai 600016
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 |
Dr.Anupama Tadepalli, Reader, Department of Periodontics, SRM Dental College, Bharathi Salai, Ramapuram Campus,Chennai
Chennai
TAMIL NADU
600089
India |
| Phone |
9677065517 |
| Fax |
|
| Email |
anupamamds@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Periodontology,
SRM Dental College |
|
|
Primary Sponsor
|
| Name |
Dr Anupama Tadepalli |
| Address |
Dr Anupama Tadepalli, Reader, Department of Periodontics, SRM Dental College, Bharathi Salai, Ramapuram Campus,Chennai |
| Type of Sponsor |
Other [Self funded] |
|
|
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 Anupama Tadepalli |
SRM Dental College |
Department of Periodontics,4th floor, Post graduate section, SRM Dental College,
Bharathi Salai, Ramapuram, Chennai 600016
Chennai
TAMIL NADU |
9677065517
anupamamds@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee and Review board, SRM Dental College |
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 |
Coronally advanced flap and Advanced platelet rich fibrin |
Recession sites treated with Coronally advanced flap and Advanced platelet rich fibrin (CAF + A PRF).The patients will be followed up for 6months. Clinical parameters will be measured at baseline, 3 months and 6 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Systematically healthy individuals manifesting with millers class I and II recession defects in maxillary anterior teeth and premolars.
2. Minimum recession depth ≥ 2mm
|
|
| ExclusionCriteria |
| Details |
1. Millers class III and 1V gingival recession
2. Recession sites with probing depth ≥ 4mm and teeth with mobility
3. Teeth with prosthetic restoration
4. Anaemic patients
5. Smokers
6. Pregnant and lactating women
7. Patients with poor oral hygiene
8. Systemic condition /disease/ any medication influencing the periodontal therapy and disease
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Changes in Recession height
2. Root coverage percentage |
Baseline, 3 months, 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. Changes in gingival biotype |
Baseline, 6 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/05/2021 |
| Date of Study Completion (India) |
02/11/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="7"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Gingival recession is described as apical migration of the free gingival margin relative to the cemento enamel junction leading to root exposure. Research in the South Indian population found approximately 40-68% of the subjects had at least one or more gingival recession defects. Gingival recession is often associated with dentinal hypersensitivity, esthetic issues and also root caries. Periodontal plastic procedures aim to achieve complete root coverage while enhancing aesthetics by integrating mucosa and keratinized gingiva with adjacent tissues. Platelet concentrates aim at extracting all the potential elements present in the collected blood sample and providing supra-physiological concentration at the surgical site to accelerate the healing process and induce regeneration of lost tissues. The second generation platelet concentrates are formed by natural polymerization during centrifugation, resulting in a three-dimensional fibrin architecture with equilateral junctions mimicking the extracellular matrix structure, offering flexibility and elasticity. Low speed centrifugation concept (LSCC) by Choukroun et al 2014 led to the evolution of Advanced platelet rich fibrins (A-PRF, A-PRF+) Various invitro and invivo studies had shown the positive outcomes with A-PRF in hard and soft tissue regeneration. However, the potential benefit of advanced platelet rich fibrin in management of gingival recession has not yet been established. The aim of this clinical study was to evaluate and compare the clinical efficacy of L-PRF and A-PRF in the treatment of gingival recession defects. |