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Guided Lateral Sinus Lifting Using Autologous Serum Albumin/Platelet-Rich Fibrin

Computer-Guided Lateral Sinus Floor Elevation Using Autologous Serum Albumin/Platelet Rich Fibrin Combined With Serum Albumin Membrane: A Randomized Clinical Study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07348094
Enrollment
45
Registered
2026-01-16
Start date
2026-01-26
Completion date
2027-02-15
Last updated
2026-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Implant Failure Nos, Sinus Perforation

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.

Interventions

PROCEDUREGuided Lateral Sinus Lifting with bone graft

Lateral window was done using surgical guide for placement of fifteen implants in posterior edentulous maxillary regions. Then bone graft only will be used.

PROCEDUREGuided Lateral Sinus Lifting with Autologous Serum Albumin/Platelet-Rich Fibrin

Lateral window was done using surgical guide for placement of fifteen implants in posterior edentulous maxillary regions. Then an autologous Alb-PRF only will be used

PROCEDUREGuided Lateral Sinus Lifting with sticky bone

Lateral window was done using surgical guide for placement of fifteen implants in posterior edentulous maxillary regions. Then sticky bone \[bone graft with Alb-PRF\] only will be used

Sponsors

Kafrelsheikh University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

outcome assessor is masked

Intervention model description

guided Lateral sinus lift with bone graft only

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

* Males and females ≥18 years of age. * ASA I and ASA II. * Patients having partial edentulism in the posterior region of the maxilla. * Edentulous sites consist of native non augmented bone. * Horizontal ridge dimension minimum of 5mm * The vertical ridge dimension 3-6 mm. * Bone quality of D2 or D3. * Enough inter-arch distance.

Exclusion criteria

* \- Patients with uncontrolled systemic diseases. * History of chronic maxillary sinus pathology. * Heavy smokers or patients with poor oral hygiene.

Design outcomes

Primary

MeasureTime frameDescription
Implant stability12-monthsusing implant stability quotient device

Secondary

MeasureTime frameDescription
Vertical bone height gain12 monthsassessed by CBCT.by measuring the distance from alveolar crest to sinus floor

Countries

Egypt

Contacts

CONTACTwalid elamrousy
waled_hammed@den.kfs.edu.eg01229460097

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026