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CTRI Number  CTRI/2023/08/056932 [Registered on: 25/08/2023] Trial Registered Prospectively
Last Modified On: 21/08/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   DIAGNOSTIC TEST OF THE EFFECT OF A-PRF GRAFT WITH GTR MEMBRANE IN THE MANAGEMENT OF GRADE â…¡ FURCATION DEFECTS– A RANDOMIZED CONTROLLED STUDY 
Scientific Title of Study   CLINICAL AND RADIOGRAPHIC EVALUATION OF THE EFFICACY OF A PRF BLOCK WITH GTR MEMBRANE IN THE MANGAEMENT OF GRADE II FURCATION DEFECTS - A RANDOMISED CONTROL CONTROLLED 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 Kashmira R 
Designation  Post graduate student 
Affiliation  Vydehi Institute of Dental Sciences and Research Centre 
Address  DENTAL BLOCK, DEPARTMENT OF PERIODONTICS, ROOM NO 6, 82, Nallurahalli Main road, near BMTC 18th Depot, Vijayanagar, Nallurahalli, Whitefield, Bengaluru, Karnataka

Bangalore
KARNATAKA
560066
India 
Phone  09751536325  
Fax    
Email  kashmirarajappa@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Nisha KJ 
Designation  Professor and Head Of the Department 
Affiliation  Vydehi Institute of Dental Sciences and Research Centre 
Address  DENTAL BLOCK, DEPARTMENT OF PERIODONTICS, ROOM NO 6, 82, Nallurahalli Main road, near BMTC 18th Depot, Vijayanagar, Nallurahalli, Whitefield, Bengaluru, Karnataka

Bangalore
KARNATAKA
560066
India 
Phone  08105490909  
Fax    
Email  nisharejath@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Nisha KJ 
Designation  Professor and Head Of the Department 
Affiliation  Vydehi Institute of Dental Sciences and Research Centre 
Address  DENTAL BLOCK, DEPARTMENT OF PERIODONTICS, ROOM NO 6, 82, Nallurahalli Main road, near BMTC 18th Depot, Vijayanagar, Nallurahalli, Whitefield, Bengaluru, Karnataka

Bangalore
KARNATAKA
560066
India 
Phone  08105490909  
Fax    
Email  nisharejath@gmail.com  
 
Source of Monetary or Material Support  
VYDEHI INSTITUTE OF DENTAL SCIENCES AND RESEARCH CENTRE 
 
Primary Sponsor  
Name  Dr Kashmira R 
Address  82, Nallurahalli Main road, near BMTC 18th Depot, Vijayanagar, Nallurahalli, Whitefield, Bengaluru, Karnataka 
Type of Sponsor  Other [SELF] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrKashmira  Vydehi Institute of Dental Sciences and Research Centre  DEPARTMENT OF PERIODONTICS, ROOM NO 6, DENTAL BLOCK, 82, Nallurahalli Main road, near BMTC 18th Depot, Vijayanagar, Nallurahalli, Whitefield, Bengaluru, Karnataka
Bangalore
KARNATAKA 
09751536325

kashmirarajappa@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Vydehi Institute of Dental Sciences - institutional ethics committee ( VIDS-IEC)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K056||Periodontal disease, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  OSSEOAGRAFT, HEALIGUDE  local administration of 2mg of OSSEOGRAFT, 1mg of healiguide in the furcation defect 
Comparator Agent  PLATELET RICH FIBRIN, OSSEOGRAFT, HEALIGUIDE  LOCAL ADMINISTRATION OF 10ML OF PRF, 2mg of osseograft, 1mg of HEALIGUIDE in the furcation defect 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients aged between 30 and 60 years.
Patients with Grade II furcation involvement in mandibular first and second molars with probing pocket depth (PPD) of ≥ 5 mm that is indicated for periodontal surgery.
 
 
ExclusionCriteria 
Details  Presence of root caries
Internal or external root resorption
Uncontrolled systemic disorders
Molar with furcation involvement that is indicated for extraction
Metal crowns and amalgam fillings in the furcation area
Current smokers and tobacco users
Pregnant and lactating female patients
Noncooperative patients with unacceptable oral hygiene
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Radiographic defect fill
Vertical probing depth (VPD)
Horizontal probing depth (HPD).
 
baseline and 9months 
 
Secondary Outcome  
Outcome  TimePoints 
Plaque Index (PI).
Gingival Index (GI).
 
BASElINE AND 9 MONTHS 
 
Target Sample Size   Total Sample Size="24"
Sample Size from India="24" 
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 2/ Phase 3 
Date of First Enrollment (India)   01/10/2023 
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="1"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Periodontitis is a disease that is characterized by the destruction of periodontal tissue, if left untreated it will lead to different types of bone deformities. One such deformity is furcation defect. Various surgical regenerative techniques have been proposed in order to treat furcation defects of periodontitis-affected teeth. The use of autologous platelet concentrates (APCs) is gaining popularity as a source of multiple growth factors in high concentrations, for regenerative treatments in many clinical applications1. Autologous platelet concentrates are advantageously used as a cost-effective adjunct to surgical regenerative therapy, even in combination with bone grafts and barrier membranes2. Several randomized controlled trials have reported improvement of post-operative soft and hard tissue healing, and improved bone fill and attachment gain.

Platelet rich fibrin (PRF) is a second-generation autologous platelet concentrate introduced by Choukron et al 2001. Ghanaati et al in 2014 introduced a modification of PRF clots (A-PRF) by using low speed centrifugation concept which significantly increases the platelet and leuckocyte number and also releases significantly higher concentrations of key growth factors3. Further Miron et al in 2015 introduced liquid variety of PRF (i-PRF) which may accelerate the wound-healing processes with increased vascularization. The benefits of i-PRF show slow and sustained release of growth factors, by releasing the expression of transforming growth factor-β and collagen-1 mRNA along with cells migration for tissue regeneration4.

Abdallah et al in 2017 introduced a “PRF block” consisting of L-PRF mixed with i- PRF and synthetic bone graft formed into a cohesive block. This block forms a volumetric matrix which can be used to fill various osseous defects5. Jayasheela et al used A-PRF block in infrabony defects which showed significant gain in the bone volume, high defect fill, defect resolution. In A-PRF block, the cut membrane of the A-PRF acts as a biological matrix and promotes migration of osteoprogenitor cells to the centre of the graft6. Therefore, we hypothesize that formation of cohesive mass obtained from the use of A-PRF block could perform better compared to bone grafts in management of furcation defects owing to the better handling characteristics and sustained delivery of growth factors. Here, we are using demineralized bovine bone matrix (DMBM) which has been found to enhance mesenchymal cells differentiate into giant cells and chondrocytes, cartilage formation and bone formation in the vascularized areas of matrix; which enhances new tissue formation within the period of 30days. DMBM has osteoconductive and osteoinductive properties due to the inherent bone morphogenetic protein that remains behind which stimulates the adjacent undifferentiated cells to form bone7. To the best of our knowledge, there are no studies where A-PRF block with xenograft was used in the management of Grade Ⅱ furcation defects, so the aim of the present study is to evaluate the clinical and radiographic outcomes of Grade II furcation defects treated with A-PRF block and GTR membrane.

 
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