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.
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
- Conditions the study is for
- Sinus Floor Augmentation, Maxillary Sinus Floor Elevation, Sinus Lift
- 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.
United Arab Emirates1 site, 1 recruiting
- Recruiting
Gulf Medical University
Ajman, Ajman Emirate, 00000
Nesma Shemais, PhD, 0529961988, dr.nesma@gmu.ac.ae
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 group | Role | What they receive |
|---|---|---|
| Lateral sinus floor elevation using: DBBM xenograft (Bio-Oss®) | Active comparator | Not described Receives: Procedure: Lateral sinus lift with Xenograft Alone |
| Lateral sinus floor elevation using DBBM xenograft (Bio-Oss®) and L-PRF | Experimental | Not 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.
Vertical Bone Gain
mm in CBCT
Measured: 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
Measured: 6 months
Secondary outcomes (2)
Postoperative pain and Morbidity VAS score 0-10
VAS score 0-10
Measured: Days 1, 3, and 7 postoperatively
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.
- First posted30 Jun 2026
- Study start1 Jan 2026
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sinus Floor AugmentationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Gulf Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Lateral Sinus Floor Elevation Using Xenograft Versus L-PRF Block Combined With Xenograft: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07677007
- Acronym / sponsor ID
- Sinus-L-PRF
- Keywords
- maxillary sinus
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Gulf Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 30 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- Uncontrolled systemic diseases.
- Smoking more than 10 cigarettes/day.
- Active sinus pathology or chronic sinusitis.
- Previous sinus augmentation surgery.
- Pregnancy or lactation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lateral sinus lift with Xenograft AloneFollowing 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. | Procedure or surgery | Lateral sinus floor elevation using: DBBM xenograft (Bio-Oss®) |
| Lateral sinus lift using L-PRF Block + XenograftThe 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 | Procedure or surgery | Lateral sinus floor elevation using DBBM xenograft (Bio-Oss®) and L-PRF |
Primary outcome
Vertical Bone Gain
Time frame: 6 months
mm in CBCT
Histomorphometric Bone Formation (%)
Time frame: 6 months
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
2 secondary outcomes
Postoperative pain and Morbidity VAS score 0-10
Time frame: Days 1, 3, and 7 postoperatively
Surgical Complications
Time frame: baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
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Smart Scaffolds, Stronger Smiles Smarter Healing: AI-Boosted Multiphasic Scaffold Design for PDL Regeneration
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
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.