Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 7:25 AM
Study NCT ID:
NCT07348094
Status:
RECRUITING
Last Update Posted:
2026-02-18
First Post:
2026-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Guided Lateral Sinus Lifting Using Autologous Serum Albumin/Platelet-Rich Fibrin
Sponsor:
Kafrelsheikh University
Organization:
Study Overview
Official Title:
Computer-Guided Lateral Sinus Floor Elevation Using Autologous Serum Albumin/Platelet Rich Fibrin Combined With Serum Albumin Membrane: A Randomized Clinical Study
Status:
RECRUITING
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This research aimed to evaluate the effect of an autologous Alb-PRF on bone regeneration after lateral sinus lifting via 3D volumetric analysis. The null hypothesis of this research was that there would be no significant difference between the group that would be treated by lateral sinus lift and Alb-PRF application and that would be treated by lateral sinus lift with bone graft for bone regeneration.
Detailed Description:
Sinus floor augmentation became a widely accepted surgical procedure to improve the amount of bone volume before implant placement. According to the guided bone regeneration principles, in the sinus lift procedure, bone graft was demonstrated to act as space holder under the elevated sinus membrane. The osteogenic source for the bone healing derives from two different anatomic sites: the basal bone of the sinus cavity and the periosteum represented as basal cell layer of the Schneiderian membrane.
Proper and accurate design and location of the lateral side window is necessary to facilitate the sinus lifting process and help the surgeon to successfully lift the sinus membrane. In addition, direct visualization helps in better packing of the entire graft space, which is essential to provide primary stability for the simultaneous insertion of the implants with the sinus elevation procedure.
The application of digital technology has proven to be a valuable tool for diagnosis and treatment planning. Data obtained from CBCT scans, digital oral scans, and facial scans can be integrated and manipulated using special computer software, providing surgeons with an interactive interface to perform virtual surgery planning before the actual surgery.
The precision of stereolithographic guides may mitigate risks associated with anatomical variations in atrophic maxillae, potentially reducing membrane perforation and optimizing lateral window osteotomy and implant placement accuracy which are key factors this study evaluates.
Recently, the use of pure autologous concentrations of platelets, PRF, as a graft material has shown promising effects. However, the durability of PRF is limited, as it usually resorbs within 10-14 days. Thus, Mourão et al. introduced a new technique for PRF preparation, in which the resulting newly formed protein remains stable for a long time, up to 4 to 6 months. The buffy coat layer of the PRF was then mixed with the denatured albumin gel and cooled to room temperature to form a new autologous albumin gel-platelet-rich fibrin mixture (Alb-PRF) which has the ability to heal, represented by the delayed and gradual release of growth factors present in the buffy coat layer of PRF throughout the prolonged dissolution of the albumin gel.
This research aimed to evaluate the effect of an autologous Alb-PRF on bone regeneration after lateral sinus lifting via 3D volumetric analysis. The null hypothesis of this research was that there would be no significant difference between the group that would be treated by lateral sinus lift and Alb-PRF application and that would be treated by lateral sinus lift with bone graft for bone regeneration.
Proper and accurate design and location of the lateral side window is necessary to facilitate the sinus lifting process and help the surgeon to successfully lift the sinus membrane. In addition, direct visualization helps in better packing of the entire graft space, which is essential to provide primary stability for the simultaneous insertion of the implants with the sinus elevation procedure.
The application of digital technology has proven to be a valuable tool for diagnosis and treatment planning. Data obtained from CBCT scans, digital oral scans, and facial scans can be integrated and manipulated using special computer software, providing surgeons with an interactive interface to perform virtual surgery planning before the actual surgery.
The precision of stereolithographic guides may mitigate risks associated with anatomical variations in atrophic maxillae, potentially reducing membrane perforation and optimizing lateral window osteotomy and implant placement accuracy which are key factors this study evaluates.
Recently, the use of pure autologous concentrations of platelets, PRF, as a graft material has shown promising effects. However, the durability of PRF is limited, as it usually resorbs within 10-14 days. Thus, Mourão et al. introduced a new technique for PRF preparation, in which the resulting newly formed protein remains stable for a long time, up to 4 to 6 months. The buffy coat layer of the PRF was then mixed with the denatured albumin gel and cooled to room temperature to form a new autologous albumin gel-platelet-rich fibrin mixture (Alb-PRF) which has the ability to heal, represented by the delayed and gradual release of growth factors present in the buffy coat layer of PRF throughout the prolonged dissolution of the albumin gel.
This research aimed to evaluate the effect of an autologous Alb-PRF on bone regeneration after lateral sinus lifting via 3D volumetric analysis. The null hypothesis of this research was that there would be no significant difference between the group that would be treated by lateral sinus lift and Alb-PRF application and that would be treated by lateral sinus lift with bone graft for bone regeneration.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: