Clinical and Radiographic evaluation of Implant Stability and crestal bone levels of dental implants with and without injectable Platelet Rich Fibrin (i-PRF) – A Randomized Control Study
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Implant Stability And Crestal Bone Levels
Study Overview
Brief Summary
| NEED FOR THE STUDY: |
Successful osseointegration is the first step in long-term survival and stability of a dental implant. Surface modifications by implant manufacturers are aimed at improving the bone-implant contact and another technique for improving the bone-implant contact and reducing osseointegration time could be represented by the use of autologous blood derivatives that contain a rich supply of growth factors and bone-specific proteins*.*1
Injectable platelet-rich fibrin (i-PRF) is the most recent and successful advancement in PRF and is beneficial for bone augmentation of the alveolar ridge prior to or during implant placement and wound healing.2
Use of i-PRF as a surface coating performed as a chairside procedure to coat the surface of the implant just prior to placement can be implemented to improve osseointegration. It could possibly serve as a simple, economical, and effective way of ensuring better implants success and quicker treatment time. As it is in a liquid formulation, it can be evenly applied all over the implant surface.1
The scientific data regarding the i-prf coated implants is inadequate. Hence, the present study is designed to evaluate and compare implants with and without i-PRF coating.
SURFACE COATING OF IMPLANT WITH i-PRF:
Ø The osteotomy sites will be prepared using standard sequential drilling protocol for the full sequence.
Ø Just before implant placement the i-PRF will be prepared.
Ø For i-PRF preparation,10 ml of whole blood without anticoagulant will be centrifuged at 700 rpm for 3 min at room temperature. 3
Ø After 3 mins the straw-colored liquid present at the top which is i-PRF will be collected.
Ø 1.5 ml of i-PRF liquid will be used to coat the implants by dipping in i-PRF.
RESEARCH QUESTION - Does implant with i-PRF will have better implant stability and crestal bone levels when compared to implants without i-PRF?
RESEARCH HYPOTHESIS [H1] - Implant with i-PRF may have better implant stability and crestal bone levels when compared to implants without i-PRF.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 20.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1.Patients of age group
- •60 years. 2.Patients with single edentulous sites in either jaw. 3.Absence of restoration/prosthesis adjacent to edentulous site. 4.Healed extraction socket site ≥ 3 months.
Exclusion Criteria
- •1.Patients with systemic diseases.
- •3.Pregnant or lactating women.
Outcomes
Primary Outcomes
Implant Stability And Crestal Bone Levels
Time Frame: Base line & | 3 MONTHS
Secondary Outcomes
No secondary outcomes reported