| CTRI Number |
CTRI/2021/05/033726 [Registered on: 21/05/2021] Trial Registered Prospectively |
| Last Modified On: |
22/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of blood derived membrane versus tissue harvested from palate in management of gum recession |
|
Scientific Title of Study
|
“Comparative Evaluation of Clinical Efficacy of Subepithelial Connective Tissue Graft (SCTG) 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,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,Ramapuram Campus, Chennai
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,Ramapuram Campus, Chennai
Chennai
TAMIL NADU
600089
India |
| Phone |
9677065517 |
| Fax |
|
| Email |
anupamamds@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Anupama Tadepalli, Self funded |
|
|
Primary Sponsor
|
| Name |
Dr Anupama Tadepalli |
| Address |
Dr Anupama Tadepalli, Reader, Department of Periodontics, SRM Dental College,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, Ramapuram Campus, Bharathi Salai, Chennai 600089
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 (CAF plus A PRF) |
Gingival recession sites will be treated with Coronally advanced flap and Advanced platelet rich fibrin (CAF plus A PRF). patients will be followed up for 6 months post operatively. Clinical measurements will be assessed at baseline,3 and 6 months. |
| Comparator Agent |
Coronally advanced flap and sub epithelial connective tissue graft (CAF plus SCTG) |
Gingival recession sites will be treated with Coronally advanced flap and sub epithelial connective tissue graft (CAF plus SCTG). patients will be followed up for 6 months post operatively. Clinical measurements will be assessed at baseline,3 and 6 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Systematically healthy patients manifesting with millers class I and II recession defects in maxillary anteriors and premolars
2. Minimum recession height ≥ 2mm
|
|
| ExclusionCriteria |
| Details |
1. Millers class III and 1V gingival recession
2. Recession sites with probing depth ≥ 4mm and mobile teeth
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
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess and compare the changes in Recession height
|
Baseline, 3 months and 6 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess and compare the changes in gingival biotype |
Baseline, 3 months and 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)="23" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/06/2021 |
| Date of Study Completion (India) |
18/01/2023 |
| 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
|
Gingival recession is described as apical migration of the free gingival margin relative to the cemento enamel junction leading to root exposure. The prevalence of mid-buccal recession defects was 91.6% as indicated in a recent epidemiological study conducted by NHANES 2020.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. Periodontal wound healing is a complex biological mechanism where multiple cellular events occur concurrently leading to repair or regeneration.Platelets are the initial cells involved in the wound healing process. Upon activation, they release various bioactive molecules, cytokines, and adhesive proteins stimulating inflammatory cells to populate in the surgical area thereby setting the pace for the wound healing process. A-PRF obtained by centrifugation protocol of 1500rpm for 14min at 200G, exhibited porous fibrin structure with larger interfibrinous space incorporating quantitatively more platelets and inflammatory cells, evenly distributed all through the matrix releasing significantly increased growth factor proteins (VEGF, PDGF, TGF-β, IGF and EGF). A-PRF was found to contain increased levels of VEGF, responsible for neoangiogenesis, monocytes as a source for BMP’s and fibronectin for extracellular matrix formation. 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 conventional gold standard connective tissue graft and A-PRF in the treatment of gingival recession defects. |