Edentulous; Alveolar Process, AtrophyNCT03495700
Lateral Sinus Floor Elevation in Implant Therapy.
A study testing L-PRF block and DBBM in people with Edentulous; Alveolar Process, Atrophy, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
The L-PRF block is a combination of bone substitute with L-PRF. The use of a L-PRF block in bone augmentation therapies could enhance and improve bone regeneration. The primary objective of this study is to evaluate if the use of autologous leukocytes and platelet rich fibrin accelerate and promotes bone regeneration… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Edentulous; Alveolar Process, Atrophy
- What is being tested?
- L-PRF block and DBBM
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteBelgium
- Study dates
- 19 Mar 2018to 6 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males and females ≥ 18 years of age.
- Ability to understand the nature of the proposed surgical procedure and sign an informed consent form.
- ASA I and ASA II.
- In need of an implant in the posterior region of the maxilla,
- RBH of <4 mm or RBH >4 mm but no transcrestal approach possible (due to anatomy).
- Healthy oral mucosa and no active periodontal disease.
- Edentulous sites consisting of native, non-augmented bone.
Who cannot join
- General contraindications for implant placement and/or surgical treatment.
- Acute infection or residual lesions in the edentulous sites.
- Acute maxillary sinus pathosis.
- Ongoing inflammatory and/or autoimmune diseases of the oral cavity.
- Patients with poor oral hygiene who are not amenable to improvement.
- Immunosuppressants, corticosteroids, or bisphosphonate
Show all 11Show fewer
- History of malignancy, radiotherapy, or chemotherapy for malignancy within the past five years.
- Smoker > 10 cigarettes.
- Uncontrolled insulin-dependent diabetes.
- Pregnant or lactating women.
- Alcohol and drug abuse.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lateral Sinus Floor Elevation in Implant Therapy: A Randomized Controlled Clinical Trail: L-PRF Block Compared With DBBM.
The L-PRF block is a combination of bone substitute with L-PRF. The use of a L-PRF block in bone augmentation therapies could enhance and improve bone regeneration.
The primary objective of this study is to evaluate if the use of autologous leukocytes and platelet rich fibrin accelerate and promotes bone regeneration in the sinus in comparison with the standard sinus lift procedure procedure.
Read the detailed description
This is a randomized controlled clinical trial. A total of 24 patients, needing sinus lift with lateral window technique (L), will be enrolled. All patients have to fulfil all of the inclusion and none of the exclusion criteria. Written informed consent will be obtained prior to any examination carried out for study purposes. Randomization will be performed using sealed, sequentially numbered, opaque envelopes containing treatment allocation.
Under local anaesthesia, the required L will be performed. Once the blood extraction is done the surgery can start following the normal procedure for the lateral approach of sinus floor elevation. Once the preparation of the sinus floor elevation is done the randomization envelopes will be open and the selected treatment will be applied. For the test group the sub-sinus cavity will be filled with L-PRF block and the window will be closed with L-PRF membranes. For the control group the sub-sinus cavity will be filled with only DBBM and the window will be closed with a collagen membrane. Afterwards suturing will be conducted and a CBCT will be taken for control and observation.
After 6 months the subjects return for a check-up of the healing process. A CBCT will be taken to assess the bone regeneration. Implant surgery will be discussed.
With a crestal incision the implant site will be exposed. The drilling will be performed according to implant protocol and the implant will be placed. Follow-up will be till 5 year.
- Conditions
- Edentulous; Alveolar Process, Atrophy
- Being tested
- L-PRF block, DBBM
- Medical subject headings
- Mouth, Edentulous, Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-PRF blockProcedure or surgery
The use of the L-PRF block as graft material for sinus augmentation procedure will be analysed
DBBMProcedure or surgery
The use of bovine xenograft will be analysed
| Study group | Role | What they receive |
|---|---|---|
| L-PRF block | Experimental | For the test group the sub-sinus cavity will be filled with L-PRF block and the window will be closed with L-PRF membranes.
Eight tubes (9 ml) of venous blood will be collected from the patients. For 6 tubes (red cap) a 12 min centrifugation at 2700 rpm/408g RCF will be followed. Two tubes (white cap) will be centrifuged (IntraSpin, Intra-Lock, Florida, USA) for 3 minutes only to form the Liquid Fibrinogen.
The L-PRF clots will be removed from the tubes using surgical tweezers. The clots will be thereafter gently compressed into membranes using a sterile metal box (Xpression, Intra-Lock, Florida, USA).
To prepare the L-PRF Block, L-PRF membranes will be cut into small pieces and mixed with DBBM (Bio-Oss Small particles, Geistlich AG, Wolhusen, Switzerland). The Liquid Fibrinogen will be added to the homogeneous mix, and stirred gently for ± 10 seconds while shaping it to the L-PRF block Receives: Procedure: L-PRF block |
| DBBM | Active comparator | For the control group the sub-sinus cavity will be filled with deproteinized bovine bone mineral (DBBM). The product used will be a xenograft (Bio-Oss Small particles, Geistlich AG, Wolhusen, Switzerland). The window will be closed with a collagen membrane (Bio-Gide, Geistlich AG, Wolhusen, Switzerland). Receives: Procedure: DBBM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volumetric bone regeneration
Amount of bone formation after lateral sinus floor elevation scored at implant placement, measured on CBCT images. Following a healing period of 6 months a CBCT will be taken to evaluate the height and width of the newly formed bone and compare it to the initial CBCT. A 3-D volumetric analysis of the amount of gained bone is conducted with MeVisLab software.
Measured: 6 months
Secondary outcomes (2)
Implant survival
The implants inserted after sinus grafting procedures would be followed for up to 5 years. Marginal bone loss would be examined using intraoral long-cone radiographs
Measured: 5 years
Linear bone regeneration
Amount of bone formation after lateral sinus floor elevation scored at implant placement, measured on CBCT images. Following a healing period of 6 months a CBCT will be taken to evaluate the height and width of the newly formed bone and compare it to the initial CBCT. 2-D measurements will be performed.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2018
- Study start19 Mar 2018
- Primary completion14 Feb 2019
- Study completion6 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Edentulous; Alveolar Process, AtrophyStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- 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
- Model description
- This study is designed as a randomized controlled clinical trial.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Drs. Simone Cortellini, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03495700
- Sponsor's protocol ID
- Cortellini60095
- Status last verified
- Apr 2026
- First submitted
- 19 Mar 2018
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lateral Sinus Floor Elevation in Implant Therapy: A Randomized Controlled Clinical Trail: L-PRF Block Compared With DBBM.
- ClinicalTrials.gov ID
- NCT03495700
- Acronym / sponsor ID
- Cortellini60095
- Conditions
- Edentulous; Alveolar Process, Atrophy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 19 Mar 2018 (actual)
- Primary completion
- 14 Feb 2019 (actual)
- Study completion
- 6 Jun 2024 (actual)
- First posted
- 12 Apr 2018 (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.
The L-PRF block is a combination of bone substitute with L-PRF. The use of a L-PRF block in bone augmentation therapies could enhance and improve bone regeneration.
The primary objective of this study is to evaluate if the use of autologous leukocytes and platelet rich fibrin accelerate and promotes bone regeneration in the sinus in comparison with the standard sinus lift procedure procedure.
Detailed description
This is a randomized controlled clinical trial. A total of 24 patients, needing sinus lift with lateral window technique (L), will be enrolled. All patients have to fulfil all of the inclusion and none of the exclusion criteria. Written informed consent will be obtained prior to any examination carried out for study purposes. Randomization will be performed using sealed, sequentially numbered, opaque envelopes containing treatment allocation.
Under local anaesthesia, the required L will be performed. Once the blood extraction is done the surgery can start following the normal procedure for the lateral approach of sinus floor elevation. Once the preparation of the sinus floor elevation is done the randomization envelopes will be open and the selected treatment will be applied. For the test group the sub-sinus cavity will be filled with L-PRF block and the window will be closed with L-PRF membranes. For the control group the sub-sinus cavity will be filled with only DBBM and the window will be closed with a collagen membrane. Afterwards suturing will be conducted and a CBCT will be taken for control and observation.
After 6 months the subjects return for a check-up of the healing process. A CBCT will be taken to assess the bone regeneration. Implant surgery will be discussed.
With a crestal incision the implant site will be exposed. The drilling will be performed according to implant protocol and the implant will be placed. Follow-up will be till 5 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This study is designed as a randomized controlled clinical trial.
| Arm | Type | Receives |
|---|---|---|
| L-PRF block | Experimental | Procedure: L-PRF blockFor the test group the sub-sinus cavity will be filled with L-PRF block and the window will be closed with L-PRF membranes. Eight tubes (9 ml) of venous blood will be collected from the patients. For 6 tubes (red cap) a 12 min centrifugation at 2700 rpm/408g RCF will be followed. Two tubes (white cap) will be centrifuged (IntraSpin, Intra-Lock, Florida, USA) for 3 minutes only to form the Liquid Fibrinogen. The L-PRF clots will be removed from the tubes using surgical tweezers. The clots will be thereafter gently compressed into membranes using a sterile metal box (Xpression, Intra-Lock, Florida, USA). To prepare the L-PRF Block, L-PRF membranes will be cut into small pieces and mixed with DBBM (Bio-Oss Small particles, Geistlich AG, Wolhusen, Switzerland). The Liquid Fibrinogen will be added to the homogeneous mix, and stirred gently for ± 10 seconds while shaping it to the L-PRF block |
| DBBM | Active comparator | Procedure: DBBMFor the control group the sub-sinus cavity will be filled with deproteinized bovine bone mineral (DBBM). The product used will be a xenograft (Bio-Oss Small particles, Geistlich AG, Wolhusen, Switzerland). The window will be closed with a collagen membrane (Bio-Gide, Geistlich AG, Wolhusen, Switzerland). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Males and females ≥ 18 years of age.
- Ability to understand the nature of the proposed surgical procedure and sign an informed consent form.
- ASA I and ASA II.
- In need of an implant in the posterior region of the maxilla,
- RBH of <4 mm or RBH >4 mm but no transcrestal approach possible (due to anatomy).
Key exclusion criteria (11 listed)
- General contraindications for implant placement and/or surgical treatment.
- Acute infection or residual lesions in the edentulous sites.
- Acute maxillary sinus pathosis.
- Ongoing inflammatory and/or autoimmune diseases of the oral cavity.
- Patients with poor oral hygiene who are not amenable to improvement.
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 |
|---|---|---|
| L-PRF blockThe use of the L-PRF block as graft material for sinus augmentation procedure will be analysed | Procedure or surgery | L-PRF block |
| DBBMThe use of bovine xenograft will be analysed | Procedure or surgery | DBBM |
Primary outcome
Volumetric bone regeneration
Time frame: 6 months
Amount of bone formation after lateral sinus floor elevation scored at implant placement, measured on CBCT images. Following a healing period of 6 months a CBCT will be taken to evaluate the height and width of the newly formed bone and compare it to the initial CBCT. A 3-D volumetric analysis of the amount of gained bone is conducted with MeVisLab software.
2 secondary outcomes
Implant survival
Time frame: 5 years
Linear bone regeneration
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing L-PRF block and DBBM in people with Edentulous; Alveolar Process, Atrophy, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 7 inclusion and 11 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: finished, as of the sponsor's last update on 23 Apr 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 Belgium. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Volumetric bone regeneration (time frame: 6 months). 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 23 Apr 2026.