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Sinus Floor AugmentationNCT07677007

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

A study testing Lateral sinus lift with Xenograft Alone and Lateral sinus lift using L-PRF Block + Xenograft in people with Sinus Floor Augmentation and Maxillary Sinus Floor Elevation, run by Gulf Medical University at 1 site in United Arab Emirates.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 to 70 yearsHealthy volunteers can take part
What is being tested?
Lateral sinus lift with Xenograft Alone and Lateral sinus lift using L-PRF Block + Xenograft
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited Arab Emirates
Study dates
1 Jan 2026to 1 Feb 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Nesma Shemais, PhD contact

0529961988

dr.nesma@gmu.ac.ae

United Arab Emirates1 site, 1 recruiting
  • Gulf Medical University

    Ajman, Ajman Emirate, 00000

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

    Recruiting

Other trials in United Arab Emirates

About this study

Official title: 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.

Read more

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.

Being tested
Lateral sinus lift with Xenograft Alone, Lateral sinus lift using L-PRF Block + Xenograft
Keywords
maxillary sinus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lateral sinus lift with Xenograft AloneProcedure or surgery

    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 lift using L-PRF Block + XenograftProcedure or surgery

    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

Study groups in NCT07677007
Study groupRoleWhat they receive
Lateral sinus floor elevation using: DBBM xenograft (Bio-Oss®)Active comparatorNot described
Receives: Procedure: Lateral sinus lift with Xenograft Alone
Lateral sinus floor elevation using DBBM xenograft (Bio-Oss®) and L-PRFExperimentalNot described
Receives: Procedure: Lateral sinus lift using L-PRF Block + Xenograft

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Vertical Bone Gain

    mm in CBCT

    Measured: 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

    Measured: 6 months

Secondary outcomes (2)
  1. Postoperative pain and Morbidity VAS score 0-10

    VAS score 0-10

    Measured: Days 1, 3, and 7 postoperatively

  2. Surgical Complications

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

    Measured: baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jun 2026
  2. Study start1 Jan 2026
  3. Primary completion1 Jan 2027 (estimated)
  4. Study completion1 Feb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07677007
Sponsor's protocol ID
Sinus-L-PRF
Status last verified
Jun 2026
First submitted
24 Jun 2026
Last updated
30 Jun 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Lateral sinus lift with Xenograft Alone and Lateral sinus lift using L-PRF Block + Xenograft in people with Sinus Floor Augmentation and Maxillary Sinus Floor Elevation, run by Gulf Medical University at 1 site in United Arab Emirates.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Arab Emirates. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Nesma Shemais, PhD (0529961988, dr.nesma@gmu.ac.ae), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Vertical Bone Gain (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.

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