Evaluation of Lateral Sinus Floor Elevation Using Xenograft Versus L-PRF Block Combined With Xenograft

Evaluation of Lateral Sinus Floor Elevation Using Xenograft Versus L-PRF Block Combined With Xenograft: A Randomized Controlled Clinical Trial

Rehabilitation of the posterior maxilla with dental implants is frequently complicated by insufficient residual bone height resulting from alveolar ridge resorption and maxillary sinus pneumatization. Lateral sinus floor elevation has become a predictable and widely accepted procedure for increasing bone volume and enabling implant placement in severely atrophic posterior maxillary sites. The long-term success of this procedure is largely dependent on the grafting material used to maintain space beneath the elevated Schneiderian membrane and promote new bone formation.

Deproteinized bovine bone mineral (DBBM), commonly known as xenograft, remains the most extensively documented grafting material for sinus augmentation due to its osteoconductive properties, volumetric stability, and favorable long-term clinical outcomes. However, xenografts are characterized by slow remodeling and prolonged persistence of residual graft particles, which may delay replacement by vital bone. Consequently, strategies to enhance the biological activity of xenografts and accelerate bone regeneration have become an area of considerable research interest.

Leukocyte- and platelet-rich fibrin (L-PRF) is a second-generation autologous platelet concentrate containing a fibrin matrix enriched with platelets, leukocytes, cytokines, and growth factors including platelet-derived growth factor (PDGF), vascular endothelial growth factor (VEGF), and transforming growth factor-β (TGF-β). These biological mediators may enhance angiogenesis, accelerate wound healing, stimulate osteoblast proliferation, and improve bone regeneration.

Several studies have demonstrated promising outcomes when L-PRF is used in sinus augmentation procedures. Mazor et al. reported successful bone formation and implant placement following sinus augmentation using PRF as the sole grafting material after six months of healing. Histological analysis demonstrated the formation of newly regenerated vital bone within the augmented sinus compartment.

More recently, Cortellini et al. conducted a randomized controlled trial comparing L-PRF block and DBBM in lateral sinus floor elevation. Although both techniques allowed successful implant placement after six months, differences in volumetric stability and graft remodeling were observed. The authors suggested that L-PRF-containing grafts may represent a biologically active alternative capable of enhancing healing while maintaining sufficient bone volume for implant placement.

Pichotano et al. further demonstrated that combining L-PRF with DBBM accelerated bone maturation and facilitated earlier implant placement when compared with xenograft alone. Histomorphometric findings revealed greater percentages of newly formed bone and reduced healing times in the L-PRF group.

Despite these promising findings, the available evidence remains limited, and there is no clear consensus regarding whether the addition of L-PRF to xenografts results in clinically significant improvements in bone regeneration, volumetric maintenance, and implant site development. Therefore, a randomized controlled clinical trial comparing xenograft alone versus L-PRF block combined with xenograft during lateral sinus floor elevation is warranted.

Study Overview

• Status: Recruiting
• Conditions: Sinus Floor Augmentation; Sinus Lift; Maxillary Sinus Floor Elevation; Xenograft
• Intervention / Treatment: Procedure: Lateral sinus lift with Xenograft Alone; Procedure: Lateral sinus lift using L-PRF Block + Xenograft

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nesma Shemais, PhD; Phone Number: 0529961988; Email: dr.nesma@gmu.ac.ae

Study Locations

• United Arab Emirates
  • Ajman Emirate
    • Ajman, Ajman Emirate, United Arab Emirates, 00000
      • Recruiting
      • Gulf Medical University
      • Contact: Nesma Shemais, PhD; Phone Number: 0529961988; Email: dr.nesma@gmu.ac.ae

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Adults aged 21 years or older.
• Partially edentulous posterior maxilla requiring implant-supported rehabilitation.
• Residual bone height between 2 and 5 mm measured by CBCT.
• Good oral hygiene and compliance with maintenance visits.
• ASA I or II patients.
• Signed informed consent.

Exclusion Criteria:

• Uncontrolled systemic diseases.
• Smoking more than 10 cigarettes/day.
• Active sinus pathology or chronic sinusitis.
• Previous sinus augmentation surgery.
• Pregnancy or lactation.
• Bisphosphonate therapy.
• Immunocompromised patients.
• History of head and neck radiotherapy

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Lateral sinus floor elevation using: DBBM xenograft (Bio-Oss®)	Procedure: Lateral sinus lift with Xenograft Alone; Following local anesthesia, a full-thickness mucoperiosteal flap will be elevated. A lateral bony window will be created using piezoelectric surgery to minimize the risk of Schneiderian membrane perforation (4). The sinus membrane will be carefully elevated and the resulting compartment will be grafted using deproteinized bovine bone mineral (DBBM). A resorbable collagen membrane will be placed over the lateral window before flap closure.
Experimental: Lateral sinus floor elevation using DBBM xenograft (Bio-Oss®) and L-PRF	Procedure: Lateral sinus lift using L-PRF Block + Xenograft; The same surgical protocol will be followed. Immediately before surgery, venous blood will be collected and centrifuged according to the Choukroun L-PRF protocol (5). The obtained L-PRF membranes will be fragmented and mixed with DBBM particles to create an L-PRF block. The graft mixture will be placed beneath the elevated sinus membrane. Additional L-PRF membranes will be used to cover the lateral window before flap closure. This protocol follows previously published clinical methodologies evaluating L-PRF-enhanced sinus augmentation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vertical Bone Gain	mm in CBCT	6 months
Histomorphometric Bone Formation (%)	At six months, during implant placement, a trephine bur will be used to harvest a bone core biopsy from the grafted area. Specimens will be fixed, decalcified, sectioned, stained, and analyzed histomorphometrically. The following parameters will be quantified: Percentage of newly formed bone.; Percentage of residual graft particles.; Percentage of connective tissue. Histomorphometric analysis remains the gold standard for evaluating bone regeneration following sinus augmentation	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain and Morbidity VAS score 0-10	VAS score 0-10	Days 1, 3, and 7 postoperatively
Surgical Complications	Schneiderian membrane perforation.; Infection.; Graft exposure.; Sinusitis.; Wound dehiscence.	baseline

Collaborators and Investigators

• Sponsor: Gulf Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: June 24, 2026
• First Submitted That Met QC Criteria: June 24, 2026
• First Posted (Actual): June 30, 2026

Study Record Updates

• Last Update Posted (Actual): June 30, 2026
• Last Update Submitted That Met QC Criteria: June 24, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: maxillary sinus
• Additional Relevant MeSH Terms: Surgical Procedures, Operative; Transplantation; Transplantation, Heterologous
• Other Study ID Numbers: Sinus-L-PRF

Drug and device information, study documents

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