FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/07/091854 [Registered on: 28/07/2025] Trial Registered Prospectively
Last Modified On: 15/10/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Effectiveness of bone graft and fibrin treatment compared to standard healing in adults after tooth extraction 
Scientific Title of Study   Efectiveness of xenograf and injectable PRF (I-PRF) Compared to Xenograft, and unassisted healing for Socket Preservatlon in Adults U ndergoing Tooth Extraction 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  PRAMEETHA GEORGE ITTYCHERIA 
Designation  Reader 
Affiliation  Pushpagiri college of dental sciences 
Address  Pushpagiri College of Dental Sciences Department of Periodontology Pushpagiri college of Dental sciences Thiruvalla Kerala
Neelampilalil Nellimala P.O Eraviperoor
Pathanamthitta
KERALA
689107
India 
Phone  9495080021  
Fax    
Email  prameethageorgeittycheria@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  PRAMEETHA GEORGE ITTYCHERIA 
Designation  Reader 
Affiliation  Pushpagiri college of dental sciences 
Address  Prameetha George Ittycheria Reader Department of Periodontology Pushpagiri college of Dental sciences Thiruvalla Kerala India 689107
Neelampilalil Nellimala P.O Eraviperoor 689542
Pathanamthitta
KERALA
689107
India 
Phone  9495080021  
Fax    
Email  prameethageorgeittycheria@gmail.com  
 
Details of Contact Person
Public Query
 
Name  PRAMEETHA GEORGE ITTYCHERIA 
Designation  Reader 
Affiliation  Pushpagiri college of dental sciences 
Address  Prameetha George Ittycheria Reader Department of Periodontology Pushpagiri college of Dental sciences Thiruvalla Kerala
Neelampilalil Nellimala P.O Eraviperoor
Pathanamthitta
KERALA
689107
India 
Phone  9495080021  
Fax    
Email  prameethageorgeittycheria@gmail.com  
 
Source of Monetary or Material Support  
Pushpagiri college of Dental Sciences 
 
Primary Sponsor  
Name  Dr Prameetha George Ittycheria 
Address  Pushpagiri college of Dental Sciences,Medicity Perumthururthy,Thiruvalla,Kerala,India 689107  
Type of Sponsor  Other [] 
 
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 
PRAMEETHA GEORGE ITTYCHERIA  Pushpagiri college of Dental sciences  Room No 5 Department of Periodontology
Pathanamthitta
KERALA 
09495080021

prameethageorgeittycheria@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Pushpagiri Institutional Ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  complete loss of teeth  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  I-PRF ,Xenograft and membrane   Socket preservation technique using injectable platelet rich fibrin,xenograft and membrane Duration 6 month  
Comparator Agent  Group 2 Xenograft and membrane Group 3 Unassisted healing.  Socket preservation technique using xenograft and membrane in second group and third group unassisted healing. Duration 6 months 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Maxillary and mandibular single rooted teeth requiring extraction .
2. Type 1,Type 2 extraction socket (Endodontic origin, fracture, severe caries, Periodontal origin, periodontal-endodontic combined )
3. more than or equal to 18 years of age
4. Patients with no systemic diseases

 
 
ExclusionCriteria 
Details  1. Uncontrolled diabetes
2. Smokers (more than or equal to10 cigarettes/day)
3. Use of immunosuppressing medication
4. Use of anticoagulants
5. Pregnant women
6. Patients with Stage III or IV periodontal disease Grade C
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Clinically horizontal ridge width(buccolingual and mesiodistal) and vertical (mid-buccal, mid-lingual, mesial, and distal) ridge height.2 Using CBCT , (1) the mean width difference between the outer borders of the buccal and lingual cortical plates at 1, 3, and 5 mm socket depths, (2) the mean width of the buccal plate at the same depths.3.Histomorphometric analysis of the percentage of vital bone   Clinical and radiographic meaurements at baseline and at 6 months
Histomorphometric analysis at 6months 
 
Secondary Outcome  
Outcome  TimePoints 
Healing Index
socket length
bone density
 
3rd 7th 14th 21 days
baseline & after 6 months
baseline & after 6 months 
 
Target Sample Size   Total Sample Size="45"
Sample Size from India="45" 
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 3 
Date of First Enrollment (India)   20/08/2025 
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
Modification(s)  
The study will be published in indexed journal 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

Tooth extraction often leads to alveolar bone resorption, negatively affecting future prosthetic or implant rehabilitation. Socket preservation techniques have been introduced to minimize post-extraction bone loss, with biomaterials such as xenografts commonly used to maintain bone volume. Though graft materials can reduce alveolar bone resorption, grafted sites often have poor vascularization and nonvital residual particles which can negatively affect the bone to implant contact. A combination of autologous platelet concentrates with the graft which will  improve the percentage of new bone formation Recently, injectable platelet rich fibrin has gained attention for its potential to enhance wound healing and bone regeneration due to its sustained release of growth factors. However, research on the combined use of injectable platelet-rich fibrin and xenografts for socket preservation remains limited. This study evaluates the clinical, radiographic, and histological outcomes of socket preservation using injectable platelet-rich fibrin , xenograft, and a resorbable membrane, compared to xenograft with a resorbable membrane and unassisted healing. Clinical parameters, including the gingival index and wound healing index, will be evaluated. Vertical and horizontal ridge width measurements will also be assessed using a digital caliper. Additionally, radiographic measurements using CBCT imaging will be performed to evaluate horizontal and vertical ridge dimensions, buccal plate thickness, and bone density. Histologic analysis after six months will assess new vital bone formation, connective tissue, and residual bone graft. Sample size calculated using the mean and SD of the loss of ridge height in the three groups from previous study ,is 15 per group . Patients will be randomly assigned to one of three groups using a permuted block randomization fixed  method and allocation concealment by sequentially numbered sealed opaque envelops. Group 1 will receive socket preservation with xenograft, membrane, and injectable platelet-rich fibrin. Group 2 will receive xenograft and membrane  and  the control group will undergo unassisted healing. Clinical and radiographic parameters will be recorded after 6 months and the outcome assessor will be blinded. This comprehensive evaluation aims to determine the effectiveness of socket preservation using injectable platelet-rich fibrin and xenograft in maintaining ridge dimensions and increase in amount of vital bone and reduction in residual graft material there by promoting bone regeneration for future implant placement.


 
Close