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CTRI Number  CTRI/2024/03/063595 [Registered on: 05/03/2024] Trial Registered Prospectively
Last Modified On: 28/02/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Other 
Public Title of Study   Treatment of Bone Loss with Bone Graft.  
Scientific Title of Study   Comparative evaluation of demineralized freeze dried bone allograft with and without PRF membrane in the treatment of periodontal intrabony defects. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sarita Parihar 
Designation  Professor 
Affiliation  Institute of Medical Sciences, Banaras Hindu University 
Address  Room no.5, Division of Periodontology,Faculty of dental sciences,IMS,BHU,Varanasi

Varanasi
UTTAR PRADESH
221005
India 
Phone  8004925677  
Fax    
Email  saritaparihar@bhu.ac.in  
 
Details of Contact Person
Scientific Query
 
Name  Sarita Parihar 
Designation  Professor 
Affiliation  Institute of Medical Sciences, Banaras Hindu University 
Address  Room no.5,Division of Periodontology,Faculty of dental sciences,IMS,BHU,Varanasi

Varanasi
UTTAR PRADESH
221005
India 
Phone  8004925677  
Fax    
Email  saritaparihar@bhu.ac.in  
 
Details of Contact Person
Public Query
 
Name  Sarita Parihar 
Designation  Professor 
Affiliation  Institute of Medical Sciences, Banaras Hindu University 
Address  Room no. 5, Division of Periodontology,Faculty of dental sciences,IMS,BHU,Varanasi

Varanasi
UTTAR PRADESH
221005
India 
Phone  8004925677  
Fax    
Email  saritaparihar@bhu.ac.in  
 
Source of Monetary or Material Support  
Faculty of dental sciences,IMS,BHU,Varanasi 
 
Primary Sponsor  
Name  Sarita Parihar 
Address  Unit of periodontology,Faculty of dental sciences,IMS,BHU,Varanasi 
Type of Sponsor  Other [self sponsoring] 
 
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 
Dr Sarita Parihar  Faculty of dental sciences  Room number 5,Division of Periodontology, department-Faculty of dental sciences,Institute of medical sciences,Banaras Hindu University
Varanasi
UTTAR PRADESH 
8004925677

saritaparihar@bhu.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee,Institute of medical sciences,Banaras Hindu University  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K053||Chronic periodontitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  DFDBA in periodontal intrabony defects  changes are observed before the surgical procedure and after 6 months 
Intervention  DFDBA with PRF membrane in periodontal intrabony defects  Patients autologous blood is withdrawn and centrifuged to make PRF membrane. Changes are observed before the surgical procedure and after 6 months. 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  1. Patients with moderate to severe periodontitis with a probing depth (PD) ≥5mm & Intrabony
component of ≥3 mm as detected on IOPA x-ray & bone sounding.
2.Healthy individual willing for study with no systemic diseases that will influence the outcome of
therapy.
3.Not using tobacco in any form.
4. Able to achieve good oral hygiene.
5. Subjects who gave written consent.
6. Subjects who were available for follow up
 
 
ExclusionCriteria 
Details  1. Medically compromised patients with presence of any systemic disease.
2. Pregnant & Lactating women.
3. Patients taking any medication.
4. Teeth with one wall defects, furcation involvement & mobility.
5. Hypersensitivity or allergy to allograft based medical products.

 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
• Changes in PPD (Periodontal Probing Depth)
• CAL (Clinical Attachment Level)
• Radiographic bone gain
 
Baseline and after 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Changes in position of Gingival margin
Plaque Index
Gingival index

 
Baseline and after 6 months 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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 3/ Phase 4 
Date of First Enrollment (India)   25/03/2024 
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="0"
Months="8"
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  

Periodontal therapy aims to arrest disease progression and regeneration of structures lost to disease. Periodontal regeneration requires a sequence of cell migration, adherence, growth and differentiation, which have potential to increase regeneration.To be considered a regenerative modality, a material or technique must demonstrate that bone, cementum and a functional periodontal ligament can be formed on a diseased root surface.

 

Various bone materials such as autogenous grafts, demineralised freeze-dried bone allografts, bovine bone xenografts, or synthetic bone substitutes have demonstrated regenerative potential and have been successfully used in the treatment of intrabony defects. The use of demineralised freeze-dried bone allografts (DFDBA), whether alone or in combination with other treatment modalities for periodontal therapy, has repeatedly demonstrated significant improvements in both soft and hard clinical tissue parameters.Although complete periodontal regeneration is unpredictable with any regenerative therapy currently used, periodontal bone grafts show strong potential. A large body of clinical evidence clearly indicates that grafts consistently lead to better bone fill than non-grafted controls. DFDBAs have repeatedly demonstrated significant improvements in soft and hard clinical tissue parameters for the treatment of intraosseous periodontal defects. Substances present in the demineralized bone graft material, i.e., bone morphogenic proteins, stimulate local cell cycles to produce new bone. The freeze drying process destroys cells while maintaining cellular morphology and chemical integrity. These two factors, in conjunction with other materials, enhance periodontal regeneration and/or bone fill.

 

In periodontology, platelet-rich fibrin (PRF) has become a useful add-on therapy with the goal of accelerating periodontal tissue regeneration and repair. PRF is a concentrated form of platelets, growth factors, and cytokines, an autologous preparation made from the patient’s own blood. Due to its distinctive makeup, PRF can successfully encourage tissue regeneration and healing after a variety of periodontal procedures. It can enhance the results of treatments like guided tissue regeneration and bone grafting by acting as a natural scaffold to assist with the growth of new bone and connective tissue. PRF has been shown to accelerate soft tissue healing, lessen postoperative pain, and reduce swelling and inflammation. Its use in procedures including implant placement, gingival recession coverage, and flap surgeries have demonstrated enhanced wound healing and aesthetic results. The ability of PRF to create an advantageous milieu rich in cytokines and growth factors aids in improving the results of different periodontal procedures.

 

Therefore, the purpose of this study was to compare clinical and radiographic outcomes obtained with combination of PRF and DFDBA to those obtained with DFDBA alone  in treatment of periodontal intrabony defects .

 
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