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CTRI Number  CTRI/2024/07/071401 [Registered on: 26/07/2024] Trial Registered Prospectively
Last Modified On: 25/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Biological
Probiotic
Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing injectable platelet rich fibrin with allograft and amniotic membrane with probiotics with allograft and amniotic membrane in intrabony defects using papilla preservation approach 
Scientific Title of Study   Role of injectable platelet rich fibrin and allograft with amniotic membrane vs probiotic and allograft with amniotic membrane in intrabony defects using nonincised papillae surgical approach- A randomized clinical trial 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrKRekha Rani 
Designation  Head of the Department  
Affiliation  Panineeya Mahavidyalaya Institute of dental sciences and research centre 
Address  Room no 101 ,Department of Periodontics Panineeya Mahavidyalaya Institute of dental sciences and research centre, road no 5, Kamalangar Dilsuknagar,Hyderabad,

Hyderabad
TELANGANA
500060
India 
Phone  9885160094  
Fax    
Email  rekhasarat2304@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DrKRekha Rani 
Designation  Head of the Department  
Affiliation  Panineeya Mahavidyalaya Institute of dental sciences and research centre 
Address  Room no 101 ,Department of Periodontics Panineeya Mahavidyalaya Institute of dental sciences and research centre, road no 5, Kamalangar Dilsuknagar,Hyderabad,

Hyderabad
TELANGANA
500060
India 
Phone  9885160094  
Fax    
Email  rekhasarat2304@gmail.com  
 
Details of Contact Person
Public Query
 
Name  KVidya Pranathi 
Designation  Post Graduate 
Affiliation  Panineeya Mahavidyalaya Institute of dental sciences and research centre 
Address  Room no 101 ,Department of Periodontics Panineeya Mahavidyalaya Institute of dental sciences and research centre, road no 5, Kamalangar Dilsuknagar,Hyderabad,

Hyderabad
TELANGANA
500060
India 
Phone  8341083583  
Fax    
Email  vidya.pulla@gmail.com  
 
Source of Monetary or Material Support  
Panineeya Mahavidyalaya Institute of Dental Sciences and research centre Road no 5 Kamala nagar Dilshuknagar Hyderabad Telangana 500065 India 
 
Primary Sponsor  
Name  Panineeya Mahavidyalaya Institute of Dental Sciences and research centre 
Address  Road no 5 Kamala nagar Dilshuknagar Hyderabad Telangana 500065 India 
Type of Sponsor  Research institution and hospital 
 
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 
DrKVidya Pranathi  Panineeya Mahavidyalaya Institute of Dental Sciences and Research Centre  Room no 101 Department of Periodontics Road no 5 Kamalanagar Dilshuknagar
Hyderabad
TELANGANA 
8341083583

vidya.pulla@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: K053||Chronic periodontitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Group 1- 11 iPRF +allograft +amniotic membrane  Injectable Platelet rich fibrin with allograft and amniotic membrane using Non Incised Papilla Surgical Approach (NIPSA) in Intrabony defects 
Comparator Agent  Group 2-11 Probiotic +allograft +Amniotic Membrane  Probiotics with allograft and amniotic membrane using Non Incised Papilla Surgical Approach (NIPSA) in Intra bony defects 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  • Patients aged ≥ 20 years with Stage III periodontitis
• Patient having at least one tooth with intra bony defect ≥3mm {two wall or combined two to three walled intraosseous defect} (assessed by trans-gingival probing, radiographic examination)
• CAL≥ 5mm
• PD ≥6 mm.
 
 
ExclusionCriteria 
Details  • Any systemic disease that contra-indicates periodontal surgery or may affect healing.
• Smokers
• Pregnant and lactating mothers
• History of intake of antibiotics or other medications affecting the periodontium in the previous 6 months.
• Surgical periodontal therapy carried out in the past 6 months.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
• Probing pocket depth(PPD)
• Clinical Attachment level(CAL)
• Bone fill assessed by CBCT
 
Baseline and 6 months
 
 
Secondary Outcome  
Outcome  TimePoints 
• Recession depth (RD)
• Location of the tip of the papilla (LTP)
• Wound closure (WC) 
Baseline and 6 months 
 
Target Sample Size   Total Sample Size="22"
Sample Size from India="22" 
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)   06/08/2024 
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="6"
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 chronic inflammatory disorder, associated with a dysbiotic plaque biofilm, resulting in progressive destruction of the tooth-supporting apparatus and intra bony periodontal defects. Intraosseous defects are a frequent sequelae of periodontitis and when left untreated may significantly affect the long-term success of the affected teeth.
 
•       Conventional periodontal surgery results in reduction of the pocket depth, elimination of osseous defects but may also be associated with considerable loss of the tooth supporting tissue including the papillae. To overcome these problems along with associated postoperative pain, bleeding, swelling, root hypersensitivity and delayed healing, several minimally invasive and papilla preservation techniques have been employed.
The non-incised papilla surgical approach (NIPSA) is one such papilla preservation technique which was developed with the aim of achieving clinical improvements compared with marginal access â€¢       techniques. In NIPSA  an apical approach is carried out, without incisions of tissues at the level of the papillae or marginal tissues, thereby preserving the interproximal tissues which aid in retention of clot in the underlying defect and prevent collapse of marginal tissues.
•       Demineralized freeze-dried bone allograft (DFDBA) is osseoinductive and harbours a variety of growth/differentiation factors, bone morphogenetic proteins (BMPs) and is inferred to promote periodontal repair/regeneration, with significant probing pocket depth (PPD)-reduction, clinical attachment level (CAL)-gain and bone fill. It was proposed that mixing I-PRF(injectable platelet rich fibrin) with bone grafts, forming a fibrin-graft-amalgamate , enhanced the graft’s biological properties, handling and stability 
•       Injectable platelet-rich fibrin (I-PRF) is the most recent and successful advancement in PRF. It is a liquid autologous platelet concentrate created by low-speed centrifugation concept and omitting the formation of a PRF membrane. It harbours a variety of growth/differentiation factors (GFs),promotes angiogenesis, traps circulating stem cells, induces collagen synthesis, and stimulates the growth of fibroblasts and osteoblasts as well as the prolonged delivery of growth factors to the area where a wound is present.
    Probiotics are live cultures of microorganisms that confer a health benefit by exerting a biological response in the host when administered in adequate amounts. They have been proposed for  as a possible alternative to standard antimicrobial adjuvants in periodontitis where scaling and root planing therapy alone is not successful.  It is suggested that they are able to induce changes in the structure of the bacterial community, which could lead to changes in interbacterial interactions, decrease the virulent periodontopathogens, modulate the immune  response of the host and restore the balance of the oral ecosystem . 
•       Amniotic membrane serves as a fibrillar scaffold and  serves as a reservoir of stem cells, modulates angiogenesis and promote wound healing .The presence of the non-collagenous proteins in the amniotic membrane makes it superior to the collagen membrane as these proteins serve to modulate the cell behaviour in wound healing. It has been suggested combining the use of bone grafts with the barrier membrane to obtain a synergistic effect termed as Combined Periodontal Regenerative Therapy (CPRT ).

 
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