Patients with Posterior Maxillary Atrophy and Need for Sinus Lift Surgery to Allow Implant PlacementPhase 4NCT06686836
Efficacy of L-PRF Against Deproteinized Bovine Mineralized Bone (DBBM)
A Phase 4 study testing Sinus lift augmentation with bone substitute (Bio-Oss) and Open sinus lift surgery lift using Platelet- and leukocyte-rich fibrin (L-PRF) mixed with a bone substitute (Bio-Oss®(Geistlich AG, Wolhusen, Switzerland)) - L-PRF Block in people with Patients with Posterior Maxillary Atrophy and Need for Sinus Lift Surgery to Allow Implant Placement, run by University of Santiago de Compostela at 1 site in Spain.
Trial summary
Objective: The main objective of this study is to evaluate whether the use of L-PRF combined with deproteinized bovine mineralized bone (DBBM; BioOss, Geistlich Pharma®) reduces healing time, through histomorphometric analysis using bone biopsies after maxillary sinus elevation versus the use of deproteinized bovine… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Patients with Posterior Maxillary Atrophy and Need for Sinus Lift Surgery to Allow Implant Placement
- What is being tested?
- Sinus lift augmentation with bone substitute (Bio-Oss) and Open sinus lift surgery lift using Platelet- and leukocyte-rich fibrin (L-PRF) mixed with a bone substitute (Bio-Oss®(Geistlich AG, Wolhusen, Switzerland)) - L-PRF Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSpain
- Study dates
- 22 Jun 2022to 17 Apr 2024
- Phase
- Phase 4
- 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
- Patients >18 years
- Presence of oral health (periodontally healthy or periodontitis treated), with a BoP <20% and PI <20%.
- Systemically healthy, with no disease that might contraindicate oral surgery.
- Non-smokers or smokers of <10 cig/day.
- Need to place implants in postero-superior sector with a residual bone height of < 5mm (no need for vertical regeneration).
- More than 3 months since tooth extraction in the treatment area.
- Absence of sinus pathology.
Who cannot join
- Patients who, due to systemic conditions, blood extraction is not possible.
- Medication that may interfere with bone metabolism (e.g. corticosteroids, bisphosphonates).
- History of radiotherapy.
- Pregnant and/or breastfeeding women.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Department of periodontology, Faculty of Dentistry, University of Santiago de Compostela
Santiago de Compostela, 15782
About this study
Official title: Efficacy of Platelet- and Leukocyte-rich Fibrin (L-PRF) in Reducing Healing Time in Sinus Lift Combined with Deproteinized Bovine Mineralized Bone (DBBM): Randomized Clinical Trial.
Objective: The main objective of this study is to evaluate whether the use of L-PRF combined with deproteinized bovine mineralized bone (DBBM; BioOss, Geistlich Pharma®) reduces healing time, through histomorphometric analysis using bone biopsies after maxillary sinus elevation versus the use of deproteinized bovine mineralized bone (DBBM) alone.
Materials and methods: 24 patients with posterior maxillary atrophy (residual bone height <5mm without need for vertical regeneration) and need for sinus lift surgery to allow implant placement were treated ,12 DBBM (control group) 12 L-PRF block (Test group). At 4 months after sinus lift, a biopsy was taken and implants were placed with submerged healing. After 6 months, the second surgical phase was performed and another biopsy was taken. The bone samples collected were analyzed histologically and histomorphometrically. Patients received prosthetic restorations after 9 months and were followed up at 12 months. Volumetric changes were analyzed at 4 and 12 months.
Read the detailed description
The study was a double-blind randomized controlled clinical trial (RCT), with a parallel design. Patients requiring an open sinus lift procedure before implant placement.
For the procedure it was use two types of filler, L-PRF block (test group) and DBBM alone (control group).
All patients were randomized and assigned to each of the study groups through a computer-generated randomization.
The primary outcome was percentage of new bone formed after treatment by histological and histomorphometric measurement of biopsies (%NeoformedBone=(Regenerated bone/total area)x100) at 4 and 6 months.
- Conditions
- Patients with Posterior Maxillary Atrophy and Need for Sinus Lift Surgery to Allow Implant Placement
- Being tested
- Sinus lift augmentation with bone substitute (Bio-Oss), Open sinus lift surgery lift using Platelet- and leukocyte-rich fibrin (L-PRF) mixed with a bone substitute (Bio-Oss®(Geistlich AG, Wolhusen, Switzerland)) - L-PRF Block
- Keywords
- Posterior maxillary atrophy; Dental implants; Sinus lift; Bone grafting; Platelet-rich fibrin; Alveolar ridge augmentation; Bone regeneration; Bone substitutes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sinus lift augmentation with bone substitute (Bio-Oss)Procedure or surgery
A maxillary sinus lift augmentation was performed with a lateral window approach that was filled with a bone substitute (Bio-Oss®) and covered with a collagen membrane (Bio-Guide®).At 4 months after sinus lift, a biopsy was taken and implants (Starumann®) were placed with submerged healing. After 6 months, the second surgical phase was performed and another biopsy was taken. The bone samples collected were analyzed histologically and histomorphometrically.
Open sinus lift surgery lift using Platelet- and leukocyte-rich fibrin (L-PRF) mixed with a bone substitute (Bio-Oss®(Geistlich AG, Wolhusen, Switzerland)) - L-PRF BlockProcedure or surgery
A maxillary sinus lift augmentation was performed with a lateral window approach that was filled using Platelet- and leukocyte-rich fibrin (L-PRF) mixed with a bone substitute (Bio-Oss®) and covered with a collagen membrane (Bio-Guide®) (L-PRF block).
L-PRF block will be performed as described by Cortellini et al. 2018. L-PRF membranes are cut into small pieces and mixed with Bio-Oss® at a ratio of 2 membranes / 0.5 g biomaterial. Pieces of the block will be removed and compacted in the sinus cavity until it is filled.
At 4 months after sinus lift, a biopsy was taken and implants (Starumann®) were placed with submerged healing. After 6 months, the second surgical phase was performed and another biopsy was taken. The bone samples collected were analyzed histologically and histomorphometrically.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Open sinus lift surgery using a bone substitute Bio-Oss®(Geistlich AG, Wolhusen, Switzerland) alone. Receives: Procedure: Sinus lift augmentation with bone substitute (Bio-Oss) |
| Test Group | Experimental | Open sinus lift surgery lift using Platelet- and leukocyte-rich fibrin (L-PRF) mixed with a bone substitute (Bio-Oss®(Geistlich AG, Wolhusen, Switzerland)) Receives: Procedure: Open sinus lift surgery lift using Platelet- and leukocyte-rich fibrin (L-PRF) mixed with a bone substitute (Bio-Oss®(Geistlich AG, Wolhusen, Switzerland)) - L-PRF Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of new bone formed
Measured by histological and histomorphometric analysis of biopsies at 4 and 6 months after sinus lift surgery
Measured: 4 and 6 months after treatment
Secondary outcomes (4)
Percentage of remaining material (%)
Measured by histology analysis at 4 and 6 months;
Measured: 4 and 6 months after treatment
Volumetric changes of regenerated bone
Measured in millimeters according to CBCT at 4 and 12 months after maxillary sinus lift in apico-coronal and bucco-lingual orientation
Measured: baseline, 4 and 12 months after treatment
Implant stability
Mesured ISQ (>65N) at the time of implant placement and in the second surgical phase before connecting the abutment to the implant).
Measured: 4 and 6 months after treatment
Implant success
According to the criteria described by Misch,2008
Measured: 12 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2024
- Study start22 Jun 2022
- Primary completion15 Sep 2023
- Study completion17 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients with Posterior Maxillary Atrophy and Need for Sinus Lift Surgery to Allow Implant PlacementStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study compared two groups: one receiving DBBM alone (control) and the other receiving a combination of DBBM and an L-PRF block (test group).
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Santiago de Compostela
- Sponsor type
- University, hospital or other
- Collaborators
- Straumanngroup, Geistlich Pharma AG
- Responsible party
- Principal investigator, Juan Blanco Carrión, University of Santiago de Compostela
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06686836
- Sponsor's protocol ID
- ECAELEV21
- Other IDs
- 2021-005374-26
- Status last verified
- Nov 2024
- First submitted
- 11 Nov 2024
- Last updated
- 13 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Platelet- and Leukocyte-rich Fibrin (L-PRF) in Reducing Healing Time in Sinus Lift Combined with Deproteinized Bovine Mineralized Bone (DBBM): Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT06686836
- Acronym / sponsor ID
- ECAELEV21
- Conditions
- Patients with Posterior Maxillary Atrophy and Need for Sinus Lift Surgery to Allow Implant Placement
- Keywords
- Posterior maxillary atrophy; Dental implants; Sinus lift; Bone grafting; Platelet-rich fibrin; Alveolar ridge augmentation; Bone regeneration; Bone substitutes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of Santiago de CompostelaUniversity, hospital or other
- Collaborators
- Straumanngroup, Geistlich Pharma AG
- Study start
- 22 Jun 2022 (actual)
- Primary completion
- 15 Sep 2023 (actual)
- Study completion
- 17 Apr 2024 (actual)
- First posted
- 13 Nov 2024 (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.
Objective: The main objective of this study is to evaluate whether the use of L-PRF combined with deproteinized bovine mineralized bone (DBBM; BioOss, Geistlich Pharma®) reduces healing time, through histomorphometric analysis using bone biopsies after maxillary sinus elevation versus the use of deproteinized bovine mineralized bone (DBBM) alone.
Materials and methods: 24 patients with posterior maxillary atrophy (residual bone height <5mm without need for vertical regeneration) and need for sinus lift surgery to allow implant placement were treated ,12 DBBM (control group) 12 L-PRF block (Test group). At 4 months after sinus lift, a biopsy was taken and implants were placed with submerged healing. After 6 months, the second surgical phase was performed and another biopsy was taken. The bone samples collected were analyzed histologically and histomorphometrically. Patients received prosthetic restorations after 9 months and were followed up at 12 months. Volumetric changes were analyzed at 4 and 12 months.
Detailed description
The study was a double-blind randomized controlled clinical trial (RCT), with a parallel design. Patients requiring an open sinus lift procedure before implant placement.
For the procedure it was use two types of filler, L-PRF block (test group) and DBBM alone (control group).
All patients were randomized and assigned to each of the study groups through a computer-generated randomization.
The primary outcome was percentage of new bone formed after treatment by histological and histomorphometric measurement of biopsies (%NeoformedBone=(Regenerated bone/total area)x100) at 4 and 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The study compared two groups: one receiving DBBM alone (control) and the other receiving a combination of DBBM and an L-PRF block (test group).
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Procedure: Sinus lift augmentation with bone substitute (Bio-Oss)Open sinus lift surgery using a bone substitute Bio-Oss®(Geistlich AG, Wolhusen, Switzerland) alone. |
| Test Group | Experimental | Procedure: Open sinus lift surgery lift using Platelet- and leukocyte-rich fibrin (L-PRF) mixed with a bone substitute (Bio-Oss®(Geistlich AG, Wolhusen, Switzerland)) - L-PRF BlockOpen sinus lift surgery lift using Platelet- and leukocyte-rich fibrin (L-PRF) mixed with a bone substitute (Bio-Oss®(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)
- Patients >18 years
- Presence of oral health (periodontally healthy or periodontitis treated), with a BoP <20% and PI <20%.
- Systemically healthy, with no disease that might contraindicate oral surgery.
- Non-smokers or smokers of <10 cig/day.
- Need to place implants in postero-superior sector with a residual bone height of < 5mm (no need for vertical regeneration).
Key exclusion criteria (4 listed)
- Patients who, due to systemic conditions, blood extraction is not possible.
- Medication that may interfere with bone metabolism (e.g. corticosteroids, bisphosphonates).
- History of radiotherapy.
- Pregnant and/or breastfeeding women.
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 |
|---|---|---|
| Sinus lift augmentation with bone substitute (Bio-Oss)A maxillary sinus lift augmentation was performed with a lateral window approach that was filled with a bone substitute (Bio-Oss®) and covered with a collagen membrane (Bio-Guide®).At 4 months after sinus lift, a biopsy was taken and implants (Starumann®) were placed with submerged healing. After 6 months, the second surgical phase was performed and another biopsy was taken. The bone samples collected were analyzed histologically and histomorphometrically. | Procedure or surgery | Control Group |
| Open sinus lift surgery lift using Platelet- and leukocyte-rich fibrin (L-PRF) mixed with a bone substitute (Bio-Oss®(Geistlich AG, Wolhusen, Switzerland)) - L-PRF BlockA maxillary sinus lift augmentation was performed with a lateral window approach that was filled using Platelet- and leukocyte-rich fibrin (L-PRF) mixed with a bone substitute (Bio-Oss®) and covered with a collagen membrane (Bio-Guide®) (L-PRF block). L-PRF block will be performed as described by Cortellini et al. 2018. L-PRF membranes are cut into small pieces and mixed with Bio-Oss® at a ratio of 2 membranes / 0.5 g biomaterial. Pieces of the block will be removed and compacted in the sinus cavity until it is filled. At 4 months after sinus lift, a biopsy was taken and implants (Starumann®) were placed with submerged healing. After 6 months, the second surgical phase was performed and another biopsy was taken. The bone samples collected were analyzed histologically and histomorphometrically. | Procedure or surgery | Test Group |
Primary outcome
Percentage of new bone formed
Time frame: 4 and 6 months after treatment
Measured by histological and histomorphometric analysis of biopsies at 4 and 6 months after sinus lift surgery
4 secondary outcomes
Percentage of remaining material (%)
Time frame: 4 and 6 months after treatment
Volumetric changes of regenerated bone
Time frame: baseline, 4 and 12 months after treatment
Implant stability
Time frame: 4 and 6 months after treatment
Implant success
Time frame: 12 months after treatment
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 13 Nov 2024.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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 Phase 4 study testing Sinus lift augmentation with bone substitute (Bio-Oss) and Open sinus lift surgery lift using Platelet- and leukocyte-rich fibrin (L-PRF) mixed with a bone substitute (Bio-Oss®(Geistlich AG, Wolhusen, Switzerland)) - L-PRF Block in people with Patients with Posterior Maxillary Atrophy and Need for Sinus Lift Surgery to Allow Implant Placement, run by University of Santiago de Compostela at 1 site in Spain.
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 4 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 13 Nov 2024. 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 Spain. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Percentage of new bone formed (time frame: 4 and 6 months after treatment). 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 13 Nov 2024.