| 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
|
|
|
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
|
|
|
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
|
|
|
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 |