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RecruitingNCT07677007Updated Jun 30, 2026

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

An interventional study of Lateral sinus lift with Xenograft Alone and Lateral sinus lift using L-PRF Block + Xenograft in Sinus Floor Augmentation, Maxillary Sinus Floor Elevation and Sinus Lift, sponsored by Gulf Medical University. Recruiting at 1 site in United Arab Emirates. Open to participants aged 21 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-30.

Sponsored by Gulf Medical University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Jan 2026, registered Jun 2026).
  • Started Jan 2026; still recruiting 9 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
21 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Sinus Floor Augmentation
  • Maxillary Sinus Floor Elevation
  • Sinus Lift
  • Xenograft

Keywords

  • maxillary sinus
03

In context

Lead sponsor

Gulf Medical University is the lead sponsor of 40 studies on the registry; 16 are open to participants now.

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

04

Who can participate

Ages eligible
21 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

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

Study arms

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

    Procedure: Lateral sinus lift with Xenograft Alone

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

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

Interventions

  • ProcedureLateral 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.

  • ProcedureLateral 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

06

What researchers measure

Primary outcomes

  1. Vertical Bone Gain

    mm in CBCT

    Time frame: 6 months

  2. 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

    Time frame: 6 months

Secondary outcomes

  1. Postoperative pain and Morbidity VAS score 0-10

    VAS score 0-10

    Time frame: Days 1, 3, and 7 postoperatively

  2. Surgical Complications

    * Schneiderian membrane perforation. * Infection. * Graft exposure. * Sinusitis. * Wound dehiscence.

    Time frame: baseline

07

Study locations

1 of 1 sites recruiting
  • Gulf Medical University
    Ajman, Ajman Emirate 00000, United Arab Emirates
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 30, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07677007
Lead sponsor
Gulf Medical University
Responsible party
Sponsor
First posted
Jun 30, 2026
Start date
Jan 1, 2026
Primary completion
Jan 1, 2027 (estimated)
Completion
Feb 1, 2027 (estimated)
Last update
Jun 30, 2026

Study contacts

Nesma Shemais, PhD
Contact
dr.nesma@gmu.ac.ae
0529961988

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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