NCT07348094

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
10mo left

Started Jan 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress26%
Jan 2026Feb 2027

First Submitted

Initial submission to the registry

January 9, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 16, 2026

Completed
10 days until next milestone

Study Start

First participant enrolled

January 26, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2027

Expected
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2027

Last Updated

February 18, 2026

Status Verified

February 1, 2026

Enrollment Period

1 year

First QC Date

January 9, 2026

Last Update Submit

February 13, 2026

Conditions

Sinus PerforationDental Implant Failure Nos

Outcome Measures

Primary Outcomes (1)

  • Implant stability

    using implant stability quotient device

    12-months

Secondary Outcomes (1)

  • Vertical bone height gain

    12 months

Study Arms (3)

Group I

EXPERIMENTAL

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

Group II

EXPERIMENTAL

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

Group III

EXPERIMENTAL

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

Guided Lateral Sinus Lifting with bone graftPROCEDURE

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

Group I
Guided Lateral Sinus Lifting with Autologous Serum Albumin/Platelet-Rich FibrinPROCEDURE

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

Group II
Guided Lateral Sinus Lifting with sticky bonePROCEDURE

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

Group III

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

faculty of dentistry, kafrelsheikh University

Kafr ash Shaykh, Kafrelsheikh, 214312, Egypt

RECRUITING

MeSH Terms

Interventions

Bone Transplantation

Intervention Hierarchy (Ancestors)

Tissue TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsOrthopedic ProceduresSurgical Procedures, OperativeTransplantation

Central Study Contacts

walid elamrousy

CONTACT

01229460097waled_hammed@den.kfs.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
outcome assessor is masked
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: guided Lateral sinus lift with bone graft only
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Periodontology Department Faculty of Oral and Dental Medicine,Kafrelsheikh University

Study Record Dates

First Submitted

January 9, 2026

First Posted

January 16, 2026

Study Start

January 26, 2026

Primary Completion (Estimated)

January 30, 2027

Study Completion (Estimated)

February 15, 2027

Last Updated

February 18, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)