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CTRI Number  CTRI/2024/08/072532 [Registered on: 14/08/2024] Trial Registered Prospectively
Last Modified On: 13/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Comparative Evaluation of Augmentation of Compromised Alveolar Socket using Albumin Platelet Rich Fibrin Block –A Randomised Controlled Trial.  
Scientific Title of Study   A Comparative Evaluation of Augmentation of Comprimised (Kim’s type II) Alveolar Socket With or without Albumin Platelet Rich Fibrin Block –A Randomised Controlled 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  Niveditha M 
Designation  Postgraduate student 
Affiliation  Bapuji Dental college and Hospital 
Address  Room no.5, Department of Periodontics, Bapuji Dental College and Hospital, MCC B Block , MCC , Davangere, Karnataka

Davanagere
KARNATAKA
577004
India 
Phone  9611825767  
Fax    
Email  nivedithashetty1997@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Niveditha M 
Designation  Postgraduate student 
Affiliation  Bapuji Dental college and Hospital 
Address  Room no. 5, Department of Periodontics, Bapuji Dental College and Hospital, MCC B Block , MCC , Davangere, Karnataka

Davanagere
KARNATAKA
577004
India 
Phone  9986544187  
Fax    
Email  nivedithashetty1997@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Jayasheela M 
Designation  Professor 
Affiliation  Bapuji Dental college and Hospital 
Address  Room no. 5, Department of Periodontics, Bapuji Dental College and Hospital, MCC B Block , MCC , Davangere, Karnataka

Davanagere
KARNATAKA
577004
India 
Phone  9986544187  
Fax    
Email  jayasheela6@gmail.com  
 
Source of Monetary or Material Support  
Bapuji Dental College and Hospital, Davangere 
 
Primary Sponsor  
Name  Dr Niveditha M 
Address  MCC B block,MCC,Davangere,Karnataka 577004 
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 Niveditha M  Bapuji Dental College and Hospital  Room no.5, Department of Periodontics, Bapuji Dental College anbd Hospital, MCC B Block, Davangere, Karnataka
Davanagere
KARNATAKA 		 9611825767

nivedithashetty1997@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
The Institutional Review Board  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K055||Other periodontal diseases, (2) ICD-10 Condition: K055||Other periodontal diseases,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Socket preservation using Albumin PRF block  Adequate local anaesthesia (2% lignocaine with epinephrine 1:80,000) will be administered, following which an atraumatic extraction will be done using periotome. The sockets will be thoroughly debrided with hand instruments to remove any residual granulation tissue and rinsed with normal saline.Albumin-PRF block containing Albumin PRF and bioactive porous granules (bone graft) will be placed in the socket, then it will be covered with Albumin-PRF membrane and sutures will be placed. For the preparation of Albumin-PRF block, 9 ml of blood will be collected in plastic tubes and will be centrifuged at 2700 rpm (700 x g) for 8 minutes. The upper layer (platelet-poor plasma layer) will be collected in 2 mL syringes and heated at 75 degrees Celcius for 10 minutes to create denatured albumin (albumin gel). Following heating, the albumin gel will be allowed to cool to room temperature for 10 minutes. Then, liquid injectable-PRF will be drawn and will be mixed back together with the cooled albumin gel which acts as a binder to form Albumin-PRF. Later Albumin-PRF and bioactive porous granules (bone graft) is taken and mixed to form an Albumin-PRF block which will be inserted onto the prepared site and sutured. 
Comparator Agent  Unassisted physiological socket healing  Adequate local anaesthesia (2% lignocaine with epinephrine 1:80,000) will be administered, following which an atraumatic extraction will be done using periotome. The sockets will be thoroughly debrided with hand instruments to remove any residual granulation tissue and rinsed with normal saline and sutured 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  General indications-
1. Male and female patients with in the age group of 20-55years.
2. Patient with no systemic diseases (Eg. -uncontrolled diabetes, uncontrolled hypertension and bleeding disorders)
3. Patient with good oral hygiene.
Site specific indications:
1. Maxillary and mandibular anterior teeth and premolars that are indicated for extraction with buccal bone loss (Type II defect).
2. Periodontally hopeless teeth indicated for extraction.
3. The adjacent teeth should have a good periodontal health. 
 
ExclusionCriteria 
Details  1. who are smokers, alcoholics or tobacco chewers.
2. Patients not willing to participate in the study or not available for follow up.
3. Pregnant and lactating women 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To clinically evaluate the vertical height and horizontal width of the alveolar bone with or without
Albumin-PRF block in compromised (Kim’s type II) extraction sockets at baseline and 4 months
postoperatively. 		 4 months 
 
Secondary Outcome  
Outcome  TimePoints 
To radiographically evaluate the vertical height and horizontal width of the alveolar bone with or




























without Albumin-PRF block in compromised (Kim’s type II) extraction sockets at baseline and 4
months postoperatively. 		 4 months 
To radiographically evaluate the vertical height and horizontal width of the alveolar bone with or




























without Albumin-PRF block in compromised (Kim’s type II) extraction sockets at baseline and 4
months postoperatively. 		 4 months 
 
Target Sample Size   Total Sample Size="16"
Sample Size from India="16" 
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/ Phase 4 
Date of First Enrollment (India)   28/08/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  28/08/2024 
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 Yet Recruiting 
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   Tooth extraction is a common dental procedure in the management of tooth decay, complicated fractures, periodontal disease, infections and orthodontic space creation. Physiologic healing of the post-extraction socket involves a complex process of bone cells migration and maturation leading to selective bone resorption and apposition. These post extraction events result in dimensional loss in both horizontal and vertical planes of the residual alveolar ridge. Bone resorption is most pronounced during the first year after tooth extraction and the peak period is within the first three months.In order to reduce the alveolar bone resorption in horizontal and vertical dimension and the soft tissue collapse after tooth extraction, various materials and methods are used for socket preservation. The selection of graft material depends on the rate and extent of its absorption, and on the type of surgical procedure. Materials available for socket grafting include autogenous bone graft, allograft materials, xenografts, alloplasts and platelet concentrates with or without bone grafts.
 Platelet-rich fibrin (PRF) was first introduced by Choukroun et al in 2001. Various modifications of the original protocol have been used for periodontal regeneration that include leukocyte-platelet-rich fibrin (L PRF), advanced platelet-rich fibrin (A-PRF) and injectable platelet-rich fibrin (i-PRF). PRF being second generation of autologous growth factors, which encourages healing and is proposed to be associated with effective and early organization of bone substance and bone volume percentage. In addition, PRF is a platelet concentrate with leukocytes in dense fibrin matrix, which can be conveniently prepared from autogenous non anti-coagulated blood when centrifuged.
The impediment of this is its rapid degradation properties(~2weeks).Interestingly, recent research has shown that heating a liquid platelet -poor plasma(PPP) layer can prolong the resorption characteristics from 2 weeks to more than 4 months of heated albumin (albumin gel).Kobayashi et al has set out to characterize the biological features of this unique autologous membrane called Albumin-PRF, it was hypothesized that Albumin-PRF would demonstrate viable cells capable of releasing growth factors over time while simultaneously improving the cellular activity of gingival proliferation of fibroblasts. Bone graft in addition to albumin-PRF will form an albumin-PRF block. It was stated by Gheno E et al that presence of albumin in bone tissue healing, acts as an activator of endogenous progenitor cells making it a possible effective and safe adjuvant for bone regenerative procedures. Albumin-PRF block thus provides an added advantage for bone regeneration at the site along with hard and soft tissue regeneration. Radiographic assessment in diagnosis and selection of a case is the major factor, to overcome the disadvantages of conventional methods such as lack of accuracy, difficulty in reproducing the details new techniques for measurements using cone-beam computed tomography (CBCT) scans have been proposed and adopted by various studies in recent years. Thus, CBCT have made it the choice for radiographic assessment of hard tissue augmentation. The main disadvantage of unassisted normal physiological healing is it will heal with abundant loss of alveolar height and width, which will be difficult to manage with prosthetically desired implant placement. Hence the aim of this study is to evaluate and compare the augmentation with and without the use of Albumin-PRF block by evaluating clinical and radiographic (horizontal and vertical) dimensional changes in compromised type II Kim’s alveolar socket.
 
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