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CTRI Number  CTRI/2026/01/100355 [Registered on: 05/01/2026] Trial Registered Prospectively
Last Modified On: 05/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparative Clinical and Radiographic Evaluation of Xenograft, Injectable Platelet Rich Fibrin and Hyaluronic acid in the treatment of bony defect 
Scientific Title of Study   Comparative Clinical and Radiographic Evaluation of Xenograft, Xenograft with Injectable Platelet-Rich Fibrin and Xenograft with Injectable Platelet-Rich Fibrin and Hyaluronic Acid (0.2 percent) in Periodontal Intrabony Defects: a randomised control 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  Dr Sushmita Tiwari 
Designation  Postgraduate 
Affiliation  Manipal College of Dental Sciences Mangalore 
Address  Department of Periodontology 4th floor Manipal College of Dental Sciences Mangalore Manipal Academy of Higher Education Manipal karnataka Dakshina Kannada Karnataka 575001 India

Dakshina Kannada
KARNATAKA
575001
India 
Phone  7088816888  
Fax    
Email  susht0201@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sangeeta U Nayak 
Designation  Professor and I/C Head Department of periodontology 
Affiliation  Manipal College of Dental Sciences Mangalore 
Address  Department of Periodontology 4th floor Manipal College of Dental Sciences Mangalore Manipal Academy of Higher Education Manipal karnataka Dakshina Kannada Karnataka 575001 India

Dakshina Kannada
KARNATAKA
575001
India 
Phone  9880718372  
Fax    
Email  Sangeeta.nayak@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Dr Sangeeta U Nayak 
Designation  Professor and I/C Head Department of periodontology 
Affiliation  Manipal College of Dental Sciences Mangalore 
Address  Department of Periodontology 4th floor Manipal College of Dental Sciences Mangalore Manipal Academy of Higher Education Manipal karnataka Dakshina Kannada Karnataka 575001 India

Dakshina Kannada
KARNATAKA
575001
India 
Phone  9880718372  
Fax    
Email  Sangeeta.nayak@manipal.edu  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Dr Sushmita Tiwari 
Address  Manipal College of Dental Sciences Mangalore Manipal Academy of Higher Education MANIPAL KARNATAKA 575001  
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 Sushmita Tiwari  Manipal College of Dental Sciences Mangalore  Department of Periodontology 4th floor Manipal College of Dental Sciences Mangalore Manipal Academy of Higher Education Manipal karnataka Dakshina Kannada Karnataka 575001 India
Dakshina Kannada
KARNATAKA 
07088816888

susht0201@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Manipal College of Dental Sciences Mangalore   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Systemically healthy patient  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Xenograft  Use of Xenograft,Xenograft with Injectable Platelet-Rich Fibrin and Xenograft with Injectable Platelet-Rich Fibrin and Hyaluronic Acid (0.2%) treatment of periodontal intrabony defects with 3 and 6 months follow up 
Intervention  Xenograft with Injectable Platelet-Rich Fibrin and Xenograft with Injectable Platelet-Rich Fibrin and Hyaluronic Acid (0.2%)  Use of Xenograft,Xenograft with Injectable Platelet-Rich Fibrin and Xenograft with Injectable Platelet-Rich Fibrin and Hyaluronic Acid (0.2%) treatment of periodontal intrabony defects with 3 and 6 months follow up 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients suffering from stage III periodontitis with grade A or B.
Patients to have atleast one intrabony 2 or 3 wall defect in upper and lower posteriors with PPD greater or equal to 6mm , CAL greater or equal to 6 mm and an intrabony component greater or equal to 3 mm measured on digital periapical radiograph.
Vital teeth with properly performed endodontic treatment.
Plaque control instructions will be repeated until patients achieved a full mouth plaque score less than 20% and gingival index score less than 20%.
 
 
ExclusionCriteria 
Details  Patients with aggressive periodontitis.
Known allergy to any of the materials
Chronic smokers
Patients with hypertension, diabetes or any other systemic disorders which affect the outcome of the treatment.
Patients with bleeding and coagulation disorders
Pregnant and lactating mothers.
Having undergone surgical periodontal therapy in last 6 months
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Probing pocket depth
Clinical attachment level
Relative clinical attachment
Intrabony Defect Fill
Radiographic Linear Defect Depth
Percentage Defect Fill  
baseline
3 months( not needed for radiographic analysis)
6 months  
 
Secondary Outcome  
Outcome  TimePoints 
Plaque index
 
baseline
3 months
6 months 
Gingival index 
baseline
3 months
6 months 
Wound Healing index  14 th day
21 st day 
Patient Reported Outcome Measure  3 rd day
7 th day
14 th day
21 st day 
 
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   N/A 
Date of First Enrollment (India)   03/04/2026 
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="2"
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 disease characterized by the destruction of the supporting structures of the teeth including the periodontal ligament alveolar bone and gingiva
It results from a complex interplay of microbial infection and host immune response leading to progressive attachment loss and bone resorption. If left untreated periodontitis can cause tooth mobility and eventual tooth loss significantly impacting oral health and quality of life
One of the hallmark manifestations of periodontitis is the formation of periodontal intrabony defects where the alveolar bone loss creates vertical defects within the bone surrounding the tooth roots. These intrabony defects are challenging to manage due to their complex anatomy and the goal of regenerating the lost bone and periodontal ligament Effective management of these defects is critical to halt disease progression and restore periodontal health
Open flap debridement  is a common surgical procedure used to treat intrabony defects. It involves reflecting a full thickness mucoperiosteal flap to gain direct access to the root surfaces and defect area allowing thorough debridement of granulation tissue and calculus.Although Open flap debridement helps reduce pocket depth and inflammation it has limited potential to regenerate lost periodontal tissues on its own prompting the use of adjunct regenerative materials to enhance healing outcomes
Bone grafts especially Xenografts have long been considered a standard approach for periodontal regeneration owing to their osteoconductive properties ability to maintain space and predictable bone fill. These materials provide a matrix that facilitates cell migration and vascularization promoting bone regeneration with good biocompatibility and long term stability. However regenerative outcomes can be further enhanced by combining grafts with biologically active materials. Platelet rich fibrin  and particularly its injectable form has emerged as a potent adjunct in periodontal therapy
Platelet rich fibrin is an autologous platelet concentrate that contains a high concentration of growth factors which stimulate angiogenesis fibroblast proliferation and osteoblastic activity
Platelet rich fibrin also provides a fibrin matrix that acts as a scaffold for cell migration supporting both soft and hard tissue regeneration
Its ease of preparation cost effectiveness and minimal risk of immunogenic reaction make it a widely used adjunct in periodontal therapy
Injectable platelet rich fibrin  is a newer liquid form of Platelet rich fibrin that retains the same biologically active components while offering enhanced handling properties
Unlike conventional Platelet rich fibrin and injectable Platelet rich fibrin can be easily mixed with graft materials and injected into defect sites ensuring intimate contact with the surrounding tissues This promotes better growth factor delivery  improves angiogenesis  and accelerates tissue healing making injectable Platelet rich fibrin particularly suitable for minimally invasive regenerative procedures
Another promising adjunct is Hyaluronic acid  is a naturally occurring glycosaminoglycan present in the extracellular matrix that plays a key role in wound healing, inflammation modulation and tissue hydration
Hyaluronic acid exhibits anti inflammatory properties and promotes fibroblast proliferation and angiogenesis making it a promising adjunct in periodontal regeneration
Its application in intrabony defects has shown to improve clinical outcomes by supporting tissue repair and reducing post surgical discomfort 
While each of these regenerative materials has demonstrated individual efficacy there remains a paucity of evidence directly comparing the volumetric regenerative outcomes of xenografts combined with injectable platelet rich fibrin and Hyaluronic acid in the treatment of intrabony defects.
Various methods have been adopted for pre and postsurgical evaluation of the periodontal treatment including clinical probing conventional radiographs surgical reentry and histologic examination However most of these methods failed to evaluate the exact morphology of the periodontal tissues The advent of cone beam computed tomography enabled clinicians to precisely identify the three dimensional morphology of the osseous defects along with volumetric assessment of healing periodontal tissues Effectiveness of the surgical procedure and material used have been assessed in periodontal research by various means CBCT is one of the noninvasive methods where the volumetric assessment of the bone defect can be done and its application provides significant aid for better understanding of the furcation defects.
Thus aim of present study is to compare clinical and radiographic evaluation of xenograft xenograft with injectable platelet rich fibrin and xenograft with injectable platelet rich fibrin and  hyaluronic acid in periodontal intrabony defects at baseline and 6 months follow up
 
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