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CTRI Number  CTRI/2023/11/059644 [Registered on: 07/11/2023] Trial Registered Prospectively
Last Modified On: 02/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To compare & evaluate the efficacy of artificial bone particles with specialized blood clot in the treatment of severe gum disease 
Scientific Title of Study   Comparative Clinical & Radiographic Evaluation of Autologous Advanced Platelet Rich Fibrin (A-PRF+) with Bioactive Glass (PerioGlas®) & Autologous Advanced Platelet Rich Fibrin (A-PRF+) with Demineralized Freeze Dried Bone Allograft (DFDBA) in the Treatment of Intrabony Defects in Chronic Periodontitis Patients- A Randomized 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  Dr Monika Patil 
Designation  First Year Post Graduate MDS, Department of Periodontics 
Affiliation  Nair Hospital Dental College 
Address  Room no. 201, Department of Periodontics Nair Hospital Dental College, Mumbai Maharashtra, 400008 India

Mumbai
MAHARASHTRA
400008
India 
Phone  8275038347  
Fax    
Email  patilmonika3997@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Mala Dixit Baburaj 
Designation  Head of Department, Department of Periodontics 
Affiliation  Nair Hospital Dental College 
Address  Room no. 201, Department of Periodontics Nair Hospital Dental College, Mumbai Maharashtra, 400008 India

Mumbai
MAHARASHTRA
400008
India 
Phone  9223340938  
Fax    
Email  maladixit25@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Monika Patil 
Designation  First Year Post Graduate MDS, Department of Periodontics 
Affiliation  Nair Hospital Dental College 
Address  Room no. 201, Department of Periodontics Nair Hospital Dental College, Mumbai Maharashtra, 400008 India

Mumbai
MAHARASHTRA
400008
India 
Phone  8275038347  
Fax    
Email  patilmonika3997@gmail.com  
 
Source of Monetary or Material Support  
Nair Hospital Dental College, Mumbai 400008 
 
Primary Sponsor  
Name  Dr Monika Patil 
Address  201, Department of Periodontics, Nair Hospital Dental College, Mumbai 
Type of Sponsor  Other [Self funded] 
 
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 Monika Patil  Nair Hospital Dental College  Room No. 202, 2nd floor, Department of Periodontics, Nair Hospital Dental College, Mumbai Central, Mumbai 400008
Mumbai
MAHARASHTRA 
8275038347

patilmonika3997@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Nair Hospital Dental College Institutional Ethics Comittee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: M278||Other specified diseases of jaws, (2) ICD-10 Condition: M858||Other specified disorders of bonedensity and structure,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Autologous Advanced Platelet Rich Fibrin (A-PRF) with Bioactive Glass  Autologous Advanced Platelet Rich Fibrin (A-PRF) with Bioactive Glass (PerioGlas®) duration- 1 day 
Comparator Agent  Autologous Advanced Platelet Rich Fibrin (A-PRF) with Demineralized Freeze Dried Bone Allograft (DFDBA)  Autologous Advanced Platelet Rich Fibrin (A-PRF) with Demineralized Freeze Dried Bone Allograft (DFDBA) duration- 1 day 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1)Patients in the age group between 30-60 yrs.
2)Patients diagnosed with Chronic Periodontitis.
3)Patients who are non-smokers or do not consume tobacco in any other form.
4)Patients are in good systemic health with no contraindication to periodontal surgery.
5) Patients having pocket depths >5mm, intraosseous defects > 3mm and with radiographic evidence of vertical / angular bone loss in the affected sites.

 
 
ExclusionCriteria 
Details  1) One-walled osseous defects.
2) Patients suffering from any systemic diseases or with a compromised immune system.
3) Patients who had received any type of periodontal therapy for the past 6 months.
4) Patients taking immunosuppressant drugs like corticosteroids.
5) Patients with a known history of allergy to Doxycycline or Chlorhexidine or any other medicine used in the study.
6) Patients showing unacceptable oral hygiene compliance during / after Phase I periodontal therapy.
7) Patients taking any drug known to cause gingival enlargement.
8) Pregnant and/or lactating mothers.

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Plaque Index (P.I.) (Tureskey-Gilmore-Glickman Modification of Quigley Hein)

2. Gingival Index (G.I.) (Loe & Silness, 1963)

3. Probing Pocket Depth (PPD)

4. Clinical Attachment Level (CAL)
 
Baseline, 1 Month, 3 Months, 6 Months 
 
Secondary Outcome  
Outcome  TimePoints 
Measurement of bone fill from CEJ to the base of the defect using radiovisiography (RVG) with EzDenti imaging software   Baseline, 1 Month, 3 Months, 6 Months 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   01/12/2023 
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="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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 disease leaves a historical record of the damage to periodontium in the form of periodontal attachment and bone loss. In teeth in which continued function requires additional periodontal support, optimal treatment involves not only controlling periodontal infection, but also regeneration of the lost periodontium.

Among the plethora of regenerative modalities, bone grafts and their synthetic substitutes have been used in an attempt to gain their therapeutic endpoint; the use of which dates back to Hegedes in 1923.

Since then a number of techniques and materials have been used for regeneration. Newer ceramic alloplast like bioactive glass has shown the ability to help bone regeneration and clinical insertion gain, with better results than other materials available. Bioactive glasses are a group of surface reactive glass-ceramics composed entirely of elements naturally occurring in the body (silica, calcium, phosphorous, oxygen, and sodium). It is the formation of a biologically active hydrated calcium phosphate layer at the surface of the bioactive glass which plays a key role in the formation of the bone/graft bond. [1]

 

Alloplasts, may be an effective alternative to allograft and xenografts as there is no risk of disease transmission and the supply is unlimited.

The bioactive glass enhances osteogenesis due to its properties of adsorption and concentrations of proteins that are utilized by osteoblast in order to form a mineralized extracellular matrix.[2]

 

Over the past several decades, platelet concentrates (PCs) obtained from autogenous blood extraction have emerged as potential regenerative biomaterials, such as platelet-rich plasma (PRP) and plasma rich in growth factors (PRGF).

 

In 2001, Choukroun et al introduced the second PC generation –platelet-rich fibrin (PRF), which induces a significant release of cytokines including platelet derived growth factor (PDGF), transforming growth factor (TGF)-β and vascular endothelial growth factor (VEGF) within its three-dimensional fibrin meshes.  Since then, PRF has been extensively utilized in dentistry for a variety of procedures demonstrating its effectiveness for tissue regeneration.

In 2014, by decreasing centrifugation speeds from 2700 rpm (750g) to 1300 rpm (200g), a better formulation of PRF was created with a higher number of leukocytes more evenly distributed throughout the softer clot.

 

This new formulation of PRF was given the working name advanced PRF (A-PRF). Ongoing studies have further confirmed that with slower spinning protocols, A-PRF favours a higher growth factors release than prototypical PRF which in turn may directly influence tissue regeneration by increasing fibroblast migration, proliferation and collagen mRNA levels. [3]

 

Demineralized freeze dried bone allograft (DFDBA) consists primarily of collagen with some residual proteins; including an array of bone growth and differentiation factors like bone morphogenetic proteins (BMPs), which constitute osteoinductive components of bone. In addition to BMPs, other growth factors such as platelet-derived growth factor and transforming growth factor-β are also present. BMP has been shown to up regulate the expression of cbfa1 (core-binding factor subunit alpha-1)- the master switch that regulates osteoblast differentiation. BMP exerts its effects primarily through the SMAD (Suppressor of Mothers against Decapentaplegic) pathway although other mechanisms have been suggested. [4]

 

Autogenous grafts, demineralized freeze-dried bone allografts(DFDBAs), biologic mediators alone or with DFDBAs, and bovine bone xenografts have demonstrated regenerative potential. 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, 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. [12]

 
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