| 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
|
|
|
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
|
|
|
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. |