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 Ⅱ 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
|
|
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
|
|
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 â…¡
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. |