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RecruitingNCT07348094Updated Feb 18, 2026

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

An interventional study of Guided Lateral Sinus Lifting with bone graft and Guided Lateral Sinus Lifting with Autologous Serum Albumin/Platelet-Rich Fibrin in Sinus Perforation and Dental Implant Failure Nos, sponsored by Kafrelsheikh University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-18.

Sponsored by Kafrelsheikh University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Jan 2026; still recruiting 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
45
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Sinus Perforation
  • Dental Implant Failure Nos
03

In context

Lead sponsor

Kafrelsheikh University is the lead sponsor of 285 studies on the registry; 110 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts 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

Exclusion Criteria:

  • - Patients with uncontrolled systemic diseases.
  • History of chronic maxillary sinus pathology.
  • Heavy smokers or patients with poor oral hygiene.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
45 participants (estimated)

Study arms

  • 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

  • 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

  • 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

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

06

What researchers measure

Primary outcomes

  1. Implant stability

    using implant stability quotient device

    Time frame: 12-months

Secondary outcomes

  1. Vertical bone height gain

    assessed by CBCT.by measuring the distance from alveolar crest to sinus floor

    Time frame: 12 months

07

Study locations

1 of 1 sites recruiting
  • faculty of dentistry, kafrelsheikh University
    Kafr ash Shaykh, Kafrelsheikh 214312, Egypt
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07348094
Lead sponsor
Kafrelsheikh University
Responsible party
Walid Elamrousy (Professor of Periodontology Department Faculty of Oral and Dental Medicine,Kafrelsheikh University, Kafrelsheikh University) — Principal investigator
First posted
Jan 16, 2026
Start date
Jan 26, 2026
Primary completion
Jan 30, 2027 (estimated)
Completion
Feb 15, 2027 (estimated)
Last update
Feb 18, 2026

Study contacts

walid elamrousy
Contact
waled_hammed@den.kfs.edu.eg
01229460097

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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