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

NCT07677007 | Recruiting

• 1 other identifier: Sinus-L-PRF
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sinus Floor Augmentation; Maxillary Sinus Floor Elevation; Sinus Lift; Xenograft

Keywords

maxillary sinus

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Postoperative pain and Morbidity VAS score 0-10

  Days 1, 3, and 7 postoperatively

• Surgical Complications

  baseline

Study Arms (2)

Lateral sinus floor elevation using: DBBM xenograft (Bio-Oss®)

ACTIVE COMPARATOR

Procedure: Lateral sinus lift with Xenograft Alone

Lateral sinus floor elevation using DBBM xenograft (Bio-Oss®) and L-PRF

EXPERIMENTAL

Procedure: Lateral sinus lift using L-PRF Block + Xenograft

Interventions

Lateral sinus lift using L-PRF Block + Xenograft PROCEDURE

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

Lateral sinus floor elevation using DBBM xenograft (Bio-Oss®) and L-PRF

Lateral sinus lift with Xenograft Alone PROCEDURE

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.

Lateral sinus floor elevation using: DBBM xenograft (Bio-Oss®)

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Gulf Medical University: lead

Study Sites (1)

Gulf Medical University

Ajman, Ajman Emirate, 00000, United Arab Emirates

RECRUITING

MeSH Terms

Interventions

Transplantation, Heterologous

Intervention Hierarchy (Ancestors)

Transplantation; Surgical Procedures, Operative

Central Study Contacts

Nesma Shemais, PhD

CONTACT

0529961988; dr.nesma@gmu.ac.ae

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2026
• First Posted: June 30, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: June 30, 2026

Record last verified: 2026-06

Locations

AE (1)