Alveolar Ridge AugmentationLPRF-GBRNCT04959513
GBR With L-PRF Bone Block in Early Healing Phase After Extraction
A study testing LPRF bone block in people with Alveolar Ridge Augmentation, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial summary
When the practitioners have to place an implant, it is necessary to have a sufficient amount of bone. This study propose to manage clinical situations by an approach using guided bone regeneration using an L-PRF bone block (composite graft composed of a xenograft, a membrane from the patient's blood and a collagenous… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alveolar Ridge Augmentation
- What is being tested?
- LPRF bone block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteBelgium
- Study dates
- 22 Jan 2021to Oct 2022
- 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
- To be over 18 years old.
- Be in good general health.
- Have at least one monoradicular tooth (premolar, canine or incisor) that must be extracted with the need for bone regeneration and one or more implants afterwards.
- Have a DPSI (Dutch Periodontal Screening Index) ≤ 2.
Who cannot join
- Being a smoker.
- Have "active" periodontal problems, have a DPSI > 2.
- Have a contraindication to the insertion of an implant and/or oral surgery.
- Have an active inflammatory and/or autoimmune disease of the oral cavity.
- Treatment with immunosuppressants, corticosteroids or biphosphonates.
- Have a history of cancer, radiotherapy or chemotherapy for cancer within the last 5 years.
- Have insulin-dependent diabetes.
- Have a blood disorder.
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Clinique Universitaires Saint-Luc
Brussels, 1200
Jérôme Lasserre, +3227645719, jerome.lasserre@uclouvain.be
About this study
Official title: Alveolar Ridge Augmentation Using GBR With L-PRF Bone Block in Early Healing Phase After Dental Extraction: a Consecutive Case Series
When the practitioners have to place an implant, it is necessary to have a sufficient amount of bone. This study propose to manage clinical situations by an approach using guided bone regeneration using an L-PRF bone block (composite graft composed of a xenograft, a membrane from the patient's blood and a collagenous membrane) after a short healing period of 6 to 8 weeks after tooth extraction. Alveolar ridge changes will be evaluated regarding soft and hard tissues up to 6 months.
Read the detailed description
When the practitioners have to place an implant, it is necessary to have a sufficient amount of bone. After a tooth extraction, a bone remodeling process leads to a resorption of the various sockets components. The spontaneous healing of an extraction may result in an unsuitable site for the implant placement. It is therefore sometimes necessary to perform an alveolar ridge preservation (ARP) at the time of extraction at the future implant site to compensate for this natural resorption. However, some clinical situations don't allow ARP (infection, significant bone loss, etc.) at the time of extraction. In these situations where alveolar preservation is not indicated and bone augmentation is required to recover or preserve correct bone anatomy for implant placement, other techniques must be used. Thus, in this study, the investigators propose to manage these clinical situations by an approach using guided bone regeneration using an L-PRF bone block (composite graft composed of a xenograft, a membrane from the patient's blood and a collagenous membrane) after a short healing period of 6 to 8 weeks after tooth extraction. This early approach allows soft tissue healing (easier primary closure to cover the graft), take advantage of the residual bone architecture of the socket (only at the beginning of its resorption) and allows infection resorption at the extraction site.
The outcomes are the volumetric changes of the soft and hard tissue. To evaluate this volumetric changes, 3 CBCTs and 3 digital impressions will be made at 3 different times: before extraction, before guided bone regeneration and before implant placement (5 to 8 months after regeneration).
Patients will be recruited at Cliniques Universitaires Saint-Luc, participation will be voluntary without any obligation. To be included in the experiment, patients will have to have at least one tooth from the antero-superior sector that must be extracted with the need for pre-implant bone regeneration. This need for guided bone regeneration will be based on a three-dimensional radiological examination.
The chronology of the experiment is :
- First consultation to make the diagnosis, explain the experiment and sign the informed consent.
- 1st CBCT (Cone Beam Computed Tomography) and 1st digital impression.
- Surgery: extraction of tooth(s).
- 2nd CBCT, digital impression and control of the healing of the extraction site 10 to 15 days after extraction.
- Surgery: Guided bone regeneration 6 to 8 weeks after extraction.
- Control of the healing of the site 10 to 14 days after regeneration.
- 3rd CBCT, 3rd digital impression 5 to 8 months after regeneration.
- Surgery: Implant placement. The data analysis will be done clinically with control visits after the different surgeries and volumetrically with CBCTs and optical impressions. The impressions and the radiographic images will be analysed used dedicated application (MeVisLab for the CBCTs and Gom Inspect for the impressions).
- Conditions
- Alveolar Ridge Augmentation
- Being tested
- LPRF bone block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LPRF bone blockProcedure or surgery
Guided bone regeneration using an L-PRF bone block (composite graft composed of a xenograft, a membrane from the patient's blood and a collagenous membrane) after a short healing period of 6 to 8 weeks after tooth extraction
| Study group | Role | What they receive |
|---|---|---|
| GBR with L-PRF bone block | Experimental | Guided bone regeneration using Leukocyte and platelet-rich fibrin Receives: Procedure: LPRF bone block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gain in ridge width in millimeters
Volumetric analysis of hard tissue using CBCT. They will be performed before extraction (T0), before guided bone regeneration (T1) and 6 months after regeneration before implant placement (T2). The CBCT done at T0 will be used as a reference for comparison with the CBCT T1 and T2. A high-resolution scanning protocol will be used with fixed exposure parameters and the CBCT will be adjusted to the target area to allow a significant reduction in irradiation dose. The DICOMs (Digital Imaging and Communication in Medicine) will be analysed using a dedicated application. The images taken at different times will be superimposed with an automatic algorithm and compared by 2D and 3D volumetric measurements.
Measured: 5 to 8 month after guided bone regeneration
Secondary outcomes (5)
Volumetric changes of the soft tissue in millimeters
Volumetric analysis of soft tissue using digital impressions. They will be made before extraction (T0), before guided bone regeneration (T1) and 6 months after regeneration before implant placement (T2). The impressions taken at the different times will be compared in analysis software. Oral-lingual or oral-palatal measurements will be taken in the center of the edentulous site at 1mm, 3mm and 5mm from the gingiva.
Measured: 5 to 8 month after guided bone regeneration
Need or not of an additional grafting procedure (yes or no)
Analyse of the need for further regeneration before the implant is placed.
Measured: 5 to 8 month after guided bone regeneration
Analysis of the implant's osseointegration (ISQ)
An analysis of the osseointegration of the implant using a dedicated device (Osstell IDx, Osstell AB, Göteborg, Sweden).
Measured: up to 12 months
Patient reported outcomes mesures (VAS Scale)
Analysis of the patient's feeling thanks to a "Visual Analog Scale" scale carried out 1 week after the regeneration surgery.
Measured: through study completion, an average of 1 year
Occurrence of an adverse effect
Analysis of the infection rate after regeneration.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2021
- Study start22 Jan 2021
- Primary completionApr 2022 (estimated)
- Study completionOct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar Ridge 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Collaborators
- Geistlich Pharma AG
- Responsible party
- Principal investigator, Lasserre, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- Investigators
- Jérôme Lasserre, Principal investigator, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04959513
- Sponsor's protocol ID
- 2020/19OCT/516
- Acronym
- LPRF-GBR
- Status last verified
- Jul 2021
- First submitted
- 11 Jun 2021
- Last updated
- 13 Jul 2021
- 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 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alveolar Ridge Augmentation Using GBR With L-PRF Bone Block in Early Healing Phase After Dental Extraction: a Consecutive Case Series
- ClinicalTrials.gov ID
- NCT04959513
- Acronym / sponsor ID
- LPRF-GBR / 2020/19OCT/516
- Conditions
- Alveolar Ridge Augmentation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Collaborators
- Geistlich Pharma AG
- Study start
- 22 Jan 2021 (actual)
- Primary completion
- Apr 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 13 Jul 2021 (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.
When the practitioners have to place an implant, it is necessary to have a sufficient amount of bone. This study propose to manage clinical situations by an approach using guided bone regeneration using an L-PRF bone block (composite graft composed of a xenograft, a membrane from the patient's blood and a collagenous membrane) after a short healing period of 6 to 8 weeks after tooth extraction. Alveolar ridge changes will be evaluated regarding soft and hard tissues up to 6 months.
Detailed description
When the practitioners have to place an implant, it is necessary to have a sufficient amount of bone. After a tooth extraction, a bone remodeling process leads to a resorption of the various sockets components. The spontaneous healing of an extraction may result in an unsuitable site for the implant placement. It is therefore sometimes necessary to perform an alveolar ridge preservation (ARP) at the time of extraction at the future implant site to compensate for this natural resorption. However, some clinical situations don't allow ARP (infection, significant bone loss, etc.) at the time of extraction. In these situations where alveolar preservation is not indicated and bone augmentation is required to recover or preserve correct bone anatomy for implant placement, other techniques must be used. Thus, in this study, the investigators propose to manage these clinical situations by an approach using guided bone regeneration using an L-PRF bone block (composite graft composed of a xenograft, a membrane from the patient's blood and a collagenous membrane) after a short healing period of 6 to 8 weeks after tooth extraction. This early approach allows soft tissue healing (easier primary closure to cover the graft), take advantage of the residual bone architecture of the socket (only at the beginning of its resorption) and allows infection resorption at the extraction site.
The outcomes are the volumetric changes of the soft and hard tissue. To evaluate this volumetric changes, 3 CBCTs and 3 digital impressions will be made at 3 different times: before extraction, before guided bone regeneration and before implant placement (5 to 8 months after regeneration).
Patients will be recruited at Cliniques Universitaires Saint-Luc, participation will be voluntary without any obligation. To be included in the experiment, patients will have to have at least one tooth from the antero-superior sector that must be extracted with the need for pre-implant bone regeneration. This need for guided bone regeneration will be based on a three-dimensional radiological examination.
The chronology of the experiment is :
- First consultation to make the diagnosis, explain the experiment and sign the informed consent.
- 1st CBCT (Cone Beam Computed Tomography) and 1st digital impression.
- Surgery: extraction of tooth(s).
- 2nd CBCT, digital impression and control of the healing of the extraction site 10 to 15 days after extraction.
- Surgery: Guided bone regeneration 6 to 8 weeks after extraction.
- Control of the healing of the site 10 to 14 days after regeneration.
- 3rd CBCT, 3rd digital impression 5 to 8 months after regeneration.
- Surgery: Implant placement. The data analysis will be done clinically with control visits after the different surgeries and volumetrically with CBCTs and optical impressions. The impressions and the radiographic images will be analysed used dedicated application (MeVisLab for the CBCTs and Gom Inspect for the impressions).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GBR with L-PRF bone block | Experimental | Procedure: LPRF bone blockGuided bone regeneration using Leukocyte and platelet-rich fibrin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- To be over 18 years old.
- Be in good general health.
- Have at least one monoradicular tooth (premolar, canine or incisor) that must be extracted with the need for bone regeneration and one or more implants afterwards.
- Have a DPSI (Dutch Periodontal Screening Index) ≤ 2.
Key exclusion criteria (8 listed)
- Being a smoker.
- Have "active" periodontal problems, have a DPSI > 2.
- Have a contraindication to the insertion of an implant and/or oral surgery.
- Have an active inflammatory and/or autoimmune disease of the oral cavity.
- Treatment with immunosuppressants, corticosteroids or biphosphonates.
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 |
|---|---|---|
| LPRF bone blockGuided bone regeneration using an L-PRF bone block (composite graft composed of a xenograft, a membrane from the patient's blood and a collagenous membrane) after a short healing period of 6 to 8 weeks after tooth extraction | Procedure or surgery | GBR with L-PRF bone block |
Primary outcome
Gain in ridge width in millimeters
Time frame: 5 to 8 month after guided bone regeneration
Volumetric analysis of hard tissue using CBCT. They will be performed before extraction (T0), before guided bone regeneration (T1) and 6 months after regeneration before implant placement (T2). The CBCT done at T0 will be used as a reference for comparison with the CBCT T1 and T2. A high-resolution scanning protocol will be used with fixed exposure parameters and the CBCT will be adjusted to the target area to allow a significant reduction in irradiation dose. The DICOMs (Digital Imaging and Communication in Medicine) will be analysed using a dedicated application. The images taken at different times will be superimposed with an automatic algorithm and compared by 2D and 3D volumetric measurements.
5 secondary outcomes
Volumetric changes of the soft tissue in millimeters
Time frame: 5 to 8 month after guided bone regeneration
Need or not of an additional grafting procedure (yes or no)
Time frame: 5 to 8 month after guided bone regeneration
Analysis of the implant's osseointegration (ISQ)
Time frame: up to 12 months
Patient reported outcomes mesures (VAS Scale)
Time frame: through study completion, an average of 1 year
Occurrence of an adverse effect
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2021.
- Individual participant dataSharing planned: No
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Comparison of Three Autogenous Bone and Xenograft Ratios for Horizontal Ridge Augmentation
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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.
Jérôme Lasserre principal investigator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LPRF bone block in people with Alveolar Ridge Augmentation, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain 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 4 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: status not confirmed, as of the sponsor's last update on 13 Jul 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jérôme Lasserre (+3227645719, jerome.lasserre@uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gain in ridge width in millimeters (time frame: 5 to 8 month after guided bone regeneration). 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 Jul 2021.