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CTRI Number  CTRI/2026/03/106271 [Registered on: 16/03/2026] Trial Registered Prospectively
Last Modified On: 14/03/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia
Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to compare two surgical treatments for deep gum-related bone loss—one using the patient’s own platelet-rich fibrin (i-PRF) with bonegraft and other using bonegraft alone. 
Scientific Title of Study   Efficacy of injectable platelet rich fibrin with xenograft compared to xenograft alone in the treatment of two or three wall intrabony defect in patients with stage 3 periodontitis a randomized controlled study 
Trial Acronym  nill 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  ANAGHA T 
Designation  Post graduate student  
Affiliation  Goverment dental college Thiruvananthapuram 
Address  Department of periodontics Room no A -204 Goverment dental college Medical college road Chalakkuzhi Thiruvananthapuram Kerala 695011

Thiruvananthapuram
KERALA
695011
India 
Phone  07025618919  
Fax    
Email  anaghatp96@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Bindu R Nayar 
Designation  Head of department and guide 
Affiliation  Goverment dental college Thiruvananthapuram 
Address  Department of periodontics Room no A -205 Goverment dental college Medical college road Chalakkuzhi Thiruvananthapuram Kerala 695011

Thiruvananthapuram
KERALA
695011
India 
Phone  9847237090  
Fax    
Email  brn09sai@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Bindu R Nayar 
Designation  Head of department and guide 
Affiliation  Goverment dental college Thiruvananthapuram 
Address  Department of periodontics Room no A -205 Goverment dental college Medical college road ChalakkuzhiThiruvananthapuram Kerala 695011

Thiruvananthapuram
KERALA
695011
India 
Phone  9847237090  
Fax    
Email  brn09sai@gmail.com  
 
Source of Monetary or Material Support  
Goverment dental college Medical college road Chalakkuzhi Thiruvananthapuram Kerala 695011 
 
Primary Sponsor  
Name  Dr Anagha T 
Address  Department of periodontics.Room no A204.Goverment dental college Thiruvananthapuram.Kerala .695011 
Type of Sponsor  Other [Self] 
 
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 Anagha T  Goverment dental college Thiruvananthapuram  Department of Periodontics ,Room No 204 ,medical college road ,Chalakkuzhi.695011
Thiruvananthapuram
KERALA 
7025618919

anaghatp96@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee.Goverment dental college thiruvananthapuram  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  management with i prf and xenograft.  Treatment of 2 or 3 wall intrabony defect with iprf and xenograft  
Comparator Agent  management with xenograft only  Treatment of 2 or 3 wall intrabony defect with xenograft alone.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients aged 18 years and above who is willing to participate .
2. Patient diagnosed with stage III periodontitis with clinical attachment level greater than or equal to 5mm and probing
Depth greater than or equal to 6mm
3. Two or three walled intra bony defect measuring greater than or equal to 3mm radiographically using RVG 
 
ExclusionCriteria 
Details  1. Uncontrolled systemic diseases.
2. History of periodontal surgery in the site within 6 months.
3. Current smoker or using tobacco related product.
4. Pregnant and lactating mother.
5. Patients on medications affecting bone metabolism 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Clinical attachment level in mm  Base line ,4 month 
 
Secondary Outcome  
Outcome  TimePoints 
Periodontal probing depth in mm
 
Base line ,4 Month 
Gingival recession in mm   Base line ,4 month 
Linear bone growth in mm  Base line ,4 month 
Patient satisfaction assessed using VAS Score  4 Month  
 
Target Sample Size   Total Sample Size="42"
Sample Size from India="42" 
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)   10/04/2026 
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="1"
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  



This study titled “Efficacy of Injectable Platelet Rich Fibrin (I-PRF) with Xenograft Compared to Xenograft Alone in the Treatment of Two or Three-Wall Intrabony Defects in Stage III Periodontitis – A Randomized Controlled Trial” is being conducted at the Government Dental College. The study aims to evaluate whether the addition of injectable platelet-rich fibrin (I-PRF) to xenograft provides superior clinical and radiographic outcomes compared to xenograft alone in patients diagnosed with Stage III periodontitis presenting with two- or three-wall intrabony defects. A total of 42  patients will be recruited and randomly allocated into two groups: Group A will receive xenograft combined with I-PRF, while Group B will receive xenograft alone. All participants will undergo initial phase I therapy followed by open flap debridement and placement of the respective graft material. The primary outcome measure is change in Clinical Attachment Level (CAL) at  4 months, assessed using a UNC-15 probe. Secondary outcomes include probing pocket depth, gingival recession, linear bone growth assessed radiographically using RVG, and patient satisfaction measured with VAS score. This two-arm, parallel, open-label randomized controlled trial will have follow-ups at 1 and 4 months. Data will be statistically analyzed using appropriate tests with significance set at p < 0.05. Ethical approval will be obtained from the Institutional Ethics Committee. 
 
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