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

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 Overview

• Status: Recruiting
• Conditions: Dental Implant Failure Nos; Sinus Perforation
• Intervention / Treatment: Procedure: Guided Lateral Sinus Lifting with bone graft; Procedure: Guided Lateral Sinus Lifting with Autologous Serum Albumin/Platelet-Rich Fibrin; Procedure: Guided Lateral Sinus Lifting with sticky bone

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.

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: walid elamrousy; Phone Number: 01229460097; Email: waled_hammed@den.kfs.edu.eg

Study Locations

• Egypt
  • Kafrelsheikh
    • Kafr ash Shaykh, Kafrelsheikh, Egypt, 214312
      • Recruiting
      • faculty of dentistry, kafrelsheikh University
      • Contact: walid elamrousy; Phone Number: +201005724781; Email: Waled_Hammed@den.kfs.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group I; Lateral window was done using surgical guide for placement of implants in posterior edentulous maxillary regions. Then bone graft only will be used.	Procedure: Guided 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.
Experimental: Group II; 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	Procedure: Guided 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
Experimental: Group III; 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	Procedure: Guided 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implant stability	using implant stability quotient device	12-months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vertical bone height gain	assessed by CBCT.by measuring the distance from alveolar crest to sinus floor	12 months

Collaborators and Investigators

• Sponsor: Kafrelsheikh University

Study record dates

Study Major Dates

• Study Start (Actual): January 26, 2026
• Primary Completion (Estimated): January 30, 2027
• Study Completion (Estimated): February 15, 2027

Study Registration Dates

• First Submitted: January 9, 2026
• First Submitted That Met QC Criteria: January 9, 2026
• First Posted (Actual): January 16, 2026

Study Record Updates

• Last Update Posted (Actual): February 18, 2026
• Last Update Submitted That Met QC Criteria: February 13, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Therapeutics; Surgical Procedures, Operative; Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Orthopedic Procedures; Tissue Transplantation; Bone Transplantation
• Other Study ID Numbers: KFSIRB200-907

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No