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CTRI Number  CTRI/2021/07/035226 [Registered on: 28/07/2021] Trial Registered Prospectively
Last Modified On: 27/07/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia
Diagnostic
Preventive
Screening
Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Treatment of bony problems With two types of bone growing agents.  
Scientific Title of Study   "Comparison of the effectiveness of demineralized freeze dried bone allograft and titanium-prepared platelet rich fibrin in treating intra-bonydefects under surgical operating microscope A Randomized split mouth 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 Mohan Kumar P 
Designation  Reader 
Affiliation  Vishnu Dental College 
Address  Dr. Mohan Kumar P, Reader, Department of Periodontics and Implantology, Vishnu Dental College, Vishnupur, Bhimavaram.

West Godavari
ANDHRA PRADESH
534202.
India 
Phone  7799411140  
Fax    
Email  mosups@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Mohan Kumar P 
Designation  Reader 
Affiliation  Vishnu Dental College 
Address  Dr. Mohan Kumar P, Reader, Department of Periodontics and Implantology, Vishnu Dental College, Vishnupur, Bhimavaram.

West Godavari
ANDHRA PRADESH
534202.
India 
Phone  7799411140  
Fax    
Email  mosups@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Mohan Kumar P 
Designation  Reader 
Affiliation  Vishnu Dental College 
Address  Dr. Mohan Kumar P, Reader, Department of Periodontics and Implantology, Vishnu Dental College, Vishnupur, Bhimavaram.

West Godavari
ANDHRA PRADESH
534202.
India 
Phone  7799411140  
Fax    
Email  mosups@gmail.com  
 
Source of Monetary or Material Support  
Room no 7 Block 2 Department of periodontics and implantology Vishnu dental college Vishnupur Bhimavaram west godavari district Andhra pradesh 534202 
 
Primary Sponsor  
Name  N Hari Priya 
Address  Block2 room no7 Department of periodontics and implantology 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
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 
N Hari priya  Vishnu dental college  room no 7, block -2, department of periodontics and implantology, vishnu dental college vishnupur bhimavaram pin:534202
West Godavari
ANDHRA PRADESH 
8497907936

harichowdhary1996@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K055||Other periodontal diseases,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Comparing the bone gain acquire with DFDBA and TPRF.  comparing the bone gain at 3month,6month,9 month by using radiograph.  
Intervention  T PRF and DFDBA  TPRF and dfdba will be intervened once during the flap surgery in two different intrabony defects present in the same patient . 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  Presence of at least one tooth either on bilateral sides of the mouth with persistent probing depth (PD) ≥ 5mm.
Radiographic evidence of intra-bony defects either on bilateral sides of the mouth with depth ≥ 3mm.
 
 
ExclusionCriteria 
Details  Patients with uncontrolled systemic diseases.
Patient who have underwent periodontal procedure 6 months prior.
Pregnant or lactating women.
Chronic smokers.
Patient with grade III tooth mobility
Patient with furcation involvement of grade II or more.
Patient with trauma from occlusion
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate the effectiveness of T- PRF in treating intra-bony defects based on clinical and radiographic parameters

To evaluate the effectiveness of DFDBA in treating intra-bony defects based on clinical and radiographic parameters

To compare the effectiveness of T-PRF versus DFDBA in
treating intra-bony defects based on clinical and radiographic parameters 
CLINICAL PARAMETERS
All these will be evaluated at baseline 3 months and 6 months 9 months after the surgery

RADIOGRAPHICAL PARAMETERS
These parameters will be assessed at baseline 3months 6months
9 months after surgery


 
 
Secondary Outcome  
Outcome  TimePoints 
Amount of bone fill

Defect depth
Defect angle

Percentage of bone fill 
3 months
6 months
9 months 
 
Target Sample Size   Total Sample Size="28"
Sample Size from India="28" 
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   N/A 
Date of First Enrollment (India)   20/08/2021 
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="8"
Days="21" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  not applicable

  6. For how long will this data be available start date provided 08-06-2023 and end date provided 08-07-2028?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
Periodontitis is an infectious disease of the supporting structures of the teeth
in which changes occurring within the alveolar bone are very crucial because
the destruction of the bone is responsible for mobility and tooth loss. The
resorption process of bone is usually interfered by various factors such as
severe gingival inflammation, changes within the bacterial plaque composition,
continuous or repeated trauma to the tooth by occlusal discrepancies and
systemic diseases.
One way of determining whether an inflammatory gingival lesion has
spread into the underlying periodontal structures is by radiographic evidence
of crestal alveolar bone loss and associated pocket formation. It is often
characterized by formation of intra-bony defects and the treatment of these
defects still remains a challenge to the clinician. Several regenerative
procedures have been described in the literature.

Graft material used for periodontal regeneration are categorized as autografts,
allografts, xenografts. Autografts and DFDBA have histologic evidence of pdl
regeneration in humans. Harvesting intraoral autogenous bone for pdl grafting is
often an unattractive option due to the limited quantity of bone available as well
as potential need for second surgical site. where as Decalcified freeze-dried
bone allograft (DFDBA) contains bone morphogenetic proteins (BMPs) that aid
in mesenchymal cell migration, attachment and osteogenesis have both
osteoinductive as well as osteoconductive activity and the ability to create and
maintain the space. DFDBA has been proposed as an effective regenerative
material for osseous defects.

Later on, research efforts shifted toward platelet concentrates because of the
acceleration of wound healing and stimulation of adjacent cells for the

restoration of the lost periodontium.
Platelet concentrates are way ahead of other biomaterials due to constant
release of growth factors over a time period, which are crucial for stimulation
of adjacent progenitor cells, leading to periodontal regeneration and tissue
healing.5 These platelet concentrates also have leucocytes, vitronectin,
fibronectin, bone morphogenetic proteins (BMPs), and cytokines that
contribute to different stages of the wound healing process.6 Initially, platelet-
rich plasma (PRP) was used alone or with bone graft in the treatment of intra-
bony defects. Although the results were reasonable, due to the risk of
antigenicity as a result of the addition of bovine anti-thrombin, leucocyte-
platelet-rich fibrin (L-PRF) was introduced, which does not require any kind of
anticoagulant.
 
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