| CTRI Number |
CTRI/2022/07/044099 [Registered on: 18/07/2022] Trial Registered Prospectively |
| Last Modified On: |
06/07/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Treatment of gum deficiency using two layered membrane prepared from blood |
|
Scientific Title of Study
|
Comparative evaluation of the clinical efficacy of bi layered platelet-rich fibrin membrane obtained by low speed centrifugation concept in the management of gingival recession: Randomized controlled clinical trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anupama Tadepalli |
| Designation |
Professor |
| Affiliation |
SRM Dental College, Ramapuram, Tamil Nadu |
| Address |
Department of Periodontology, 3rd floor, SRM Dental College, Bharathi salai, Ramapuram Campus,Chennai
Department of Periodontology, 3rd floor, SRM Dental College, Bharathi salai, Ramapuram Campus,Chennai
Chennai
TAMIL NADU
600089
India |
| Phone |
09677065517 |
| Fax |
|
| Email |
anupamamds@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anupama Tadepalli |
| Designation |
Professor |
| Affiliation |
SRM Dental College, Ramapuram, Tamil Nadu |
| Address |
Department of Periodontology, 3rd floor, SRM Dental College, Bharathi salai, Ramapuram Campus,Chennai
Department of Periodontology, 3rd floor, SRM Dental College, Bharathi salai, Ramapuram Campus,Chennai
Chennai
TAMIL NADU
600089
India |
| Phone |
09677065517 |
| Fax |
|
| Email |
anupamamds@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anupama Tadepalli |
| Designation |
Professor |
| Affiliation |
SRM Dental College, Ramapuram, Tamil Nadu |
| Address |
Department of Periodontology, 3rd floor, SRM Dental College, Bharathi salai, Ramapuram Campus,Chennai
Department of Periodontology, 3rd floor, SRM Dental College, Bharathi salai, Ramapuram Campus,Chennai
Chennai
TAMIL NADU
600089
India |
| Phone |
09677065517 |
| Fax |
|
| Email |
anupamamds@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Periodontology, SRM Dental College |
|
|
Primary Sponsor
|
| Name |
Anupama Tadepalli |
| Address |
Department of Periodontology, SRM Dental College, Ramapuram campus, Bharathi Salai, 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 |
| DrAnupama Tadepalli |
SRM Dental College and Hospital |
Dept. of Periodontology, 4th floor, SRM Dental College, Bharathi salai, Ramapuram Campus,Chennai,600089
Chennai
TAMIL NADU |
09677065517
anupamamds@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional 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 |
Group 1: Coronally advanced flap with bi layered platelet rich fibrin |
Gingival recession sites will be managed using bi layered platelet rich fibrin membranes and coronally advanced flap |
| Intervention |
Group 2: Coronally advanced flap with single layer platelet rich fibrin membrane |
Gingival recession sites will be managed using single layer platelet rich fibrin membrane and coronally advanced flap |
| Comparator Agent |
Group 3: Coronally advanced flap with connective tissue graft |
Gingival recession sites will be managed using connective tissue graft obtained from palate and coronally advanced flap |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with Cairo’s RT1 & RT2 recession defects in maxillary anteriors and premolars
2. Minimum recession depth ≥ 2mm
|
|
| ExclusionCriteria |
| Details |
1. Recession sites with probing depth ≥ 4mm and mobile teeth
2. Teeth with prosthetic restorations
3. Anemic patients
4. Individuals with Platelet disorders
5. Individuals with infectious diseases
6. Patients with poor oral hygiene
7. 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
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To assess and compare the changes in Recession height (RH) between the study groups at baseline and 6 months follow up.
2. To compare the mean Root coverage% (RC%) between the study groups at 6 months follow up.
|
Baseline, 3 months and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To evaluate the comparative changes in Gingival thickness (GT) between the study groups at baseline and 6 months follow up.
2. To evaluate the comparative changes in Width of keratinized tissue (WKT) between the study groups at baseline and 6 months follow up
|
Baseline and 6 months |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
Final Enrollment numbers achieved (Total)= "45"
Final Enrollment numbers achieved (India)="45" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/07/2022 |
| Date of Study Completion (India) |
03/07/2023 |
| 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
|
Not yet 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 multilayer 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 single/ bi layered A-PRF in the treatment of gingival recession defects. |