FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/02/080033 [Registered on: 07/02/2025] Trial Registered Prospectively
Last Modified On: 03/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Other 
Public Title of Study   Advanced-PRF(A-PRF) and Titanium-PRF(T-PRF) in maxillary sinus lift 
Scientific Title of Study   A Comparative Evaluation of Advanced PRF (A-PRF) And Titanium PRF (T-PRF) in Maxillary Sinus Augmentation Through Crestal Approach in Implant Placement - An In Vivo Study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Kratika Rastogi 
Designation  PG Resident 
Affiliation  Sardar Post Graduate Institute of Dental and Medical Sciences 
Address  Sardar Post Graduate Institute of Dental and Medical Sciences Lucknow Uttar Pradesh 226029 India

Lucknow
UTTAR PRADESH
226029
India 
Phone  9935547662  
Fax    
Email  kratiak31oct@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Love Kumar Bhatia 
Designation  PG Resident 
Affiliation  Sardar Post Graduate Institute of Dental and Medical Sciences 
Address  Sardar Post Graduate Institute of Dental and Medical Sciences

Lucknow
UTTAR PRADESH
226025
India 
Phone  9451833111  
Fax    
Email  drlovebhatia12@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Kratika Rastogi 
Designation  PG Resident 
Affiliation  Sardar Post Graduate Institute of Dental and Medical Sciences 
Address  Sardar Post Graduate Institute of Dental and Medical Sciences

Lucknow
UTTAR PRADESH
226029
India 
Phone  9935547662  
Fax    
Email  kratiak31oct@gmail.com  
 
Source of Monetary or Material Support  
Department of prosthodontics Sardar Patel Postgraduate institute of Dental and Medical Sciences Lucknow 226025 India 
 
Primary Sponsor  
Name  Kratika Rastogi 
Address  Department of prosthodontics Sardar Patel Postgraduate institute of Dental and Medical Sciences Lucknow 226025 India 
Type of Sponsor  Research institution and hospital 
 
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 
Kratika Rastogi  Sardar Post Graduate Institute of Dental and Medical Sciences  First floor Dental building Department of ProsthodonticsSardar Post Graduate Institute of Dental and Medical Sciences
Lucknow
UTTAR PRADESH 
9935547662

kratika31oct@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee Sardar Patel Postgraduate institute of Dental and Medical Sciences   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K063||Horizontal alveolar bone loss,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Advanced PRF  Recently, the protocols for the preparation of PRF have been modified. Advanced PRF (A-PRF) matrices have been developed using the low-speed centrifugation concept. This involves centrifugation in glass-based vacuum tubes at a slower speed of 1500 pm for a greater time of 14 min. As a result, a more porous fibrin clot is prepared that contains a larger inter fibrous space than PRE. 
Intervention  Titanium PRF  Titanium PRF (T-PRF) is a modified form of PRF that is prepared by blood centrifugation in titanium tubes at 2800pm for 12 min. As compared to A-PRF, T-PRF is more tightly woven and has thicker fibrin. Titanium also offers improved hemocompatibility than glass; therefore, the resulting fibrin is more polymerized. Both the PRFs will be mixed in a sterilized mixing well with Bovine porous bone material Bio-Oss Bone Graft as it is highly osteoconductive, leading to effective and predictable bone regeneration.Bio OSS particles become an integral part of the newly formed bone framework and preserve volume over the long-term. The graft after mixing will be placed in the osteotomy site and will be pushed towards the lifted sinus using Slow Speed Densah Drills without irrigation and counterclockwise direction 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients willing for voluntary participation & have signed informed consent for the described procedure
Patients having good physical and mental health and well formed or moderately formed residual alveolar ridge
Systemically healthy subjects
Patients requiring Sinus augmentation prior to placement of implant
Patients well motivated for implant therapy and maintaining good oral hygiene
Patients requiring bilateral sinus lift
Bone height between 4 to 6 mm
 
 
ExclusionCriteria 
Details  Immunocompromised patients
Grafted site previous or during implant placement
Patients of chronic and aggressive periodontitis
Flapless procedures
Alcohol or drug abuse
Psychologically compromised patients
Patients with temporomandibular disorders severe residual ridge resorption orofacial tumors and gross facial deformity mucositis radiation therapy parafunctional habit
Patients with active diseases of the implant bed example residual cysts
Cancer Patients ongoing chemotherapy
Patients on steroid therapy
Severe Metabolic Diseases
Immunocompromised patients
Abnormal Platelet Function
Bisphosphonates Therapy
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The outcome of the study will help in comparing the formation of bone density using TPRF and APRF in maxillary sinus augmentation  6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Thicker bone density and good postoperative healing  6 months 
 
Target Sample Size   Total Sample Size="21"
Sample Size from India="21" 
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)   14/02/2025 
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="0"
Months="2"
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  

The present Thesis “A Comparative Evaluation of Advanced – PRF (A-PRF) And Titanium – PRF (T-PRF) in Maxillary Sinus Augmentation Through Crestal Approach in Implant Placement - An In Vivo Study” compared the regenerative potential of different preparations of platelet concentrate to access the effect of platelet rich plasma on dental implants specifically and on maxillary sinus elevation. It was held over a period of 2 years. The study was carried out on patients having ridge resorption and requiring rehabilitation involving maxillary sinus lift in the out-patients department of Prosthodontics Crown & Bridge and Implantology in Sardar Post Graduate Institute of Dental and Medical Sciences.

In this present study implants were placed using Osseodensification Densah Drills for sinus augmentation followed by bone grafting. The objective of the present study was to compare the regenerative potential of different types of platelet concentrate Advanced - PRF (A-PRF) and Titanium – PRF (T-PRF) on indirect maxillary sinus elevation using crestal approach.

Bone augmentation techniques have increasingly been indicated for re-creating adequate bone height and volume suitable for dental implant sites. This is particularly applicable in the severely atrophic posterior maxilla where sinus perforation is a very common complication and sinus floor elevation or lift is frequently considered a standard procedure.

In this study different types of platelet concentrates Advanced - PRF (A-PRF) and Titanium – PRF (T-PRF) were centrifuged at different speeds for different times to be used for bone augmentation and maxillary sinus lift.

An outcome of these platelet concentrates for bone defect and maxillary lift was evaluated after the placement of these concentrates for a period of 6 month follow up.

A CBCT was evaluated pre and post administration of these concentrates to check the bone augmentation and maxillary sinus floor changes after 6 months with evaluation of implant stability using Ostell density via CBCT.

 
Close