Bone RegenerationNCT03391258
Guided Bone Regeneration With L-PRF in the Atrophic Maxilla - The GLAM Technique
A study testing Bone Regeneration with GLAM technique in people with Bone Regeneration, run by Implantology Institute at 1 site in Portugal.
Trial summary
16 patients with severe resorbed maxillae referred to Implantology Institute® will be submitted to full arch surgery, with simultaneous implant placement and regeneration in the aesthetic zone, with the GLAM technique. Informed consents and local ethical committee clearance will be obtained. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bone Regeneration
- What is being tested?
- Bone Regeneration with GLAM technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 sitePortugal
- Study dates
- Jan 2015to Mar 2018
- 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
- ≥18years of age, ASA I or ASA II patients
Who cannot join
- ASA III or ASA IV patients; uncontrolled diabetes, immunosuppressant medication, heavy smokers or pre-surgical infectious area next to the surgical site
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Guided Bone Regeneration With L-PRF in the Atrophic Maxilla - A Pilot Clinical Trial
16 patients with severe resorbed maxillae referred to Implantology Institute® will be submitted to full arch surgery, with simultaneous implant placement and regeneration in the aesthetic zone, with the GLAM technique.
Informed consents and local ethical committee clearance will be obtained. Pre, post and 12 months' follow-up CBCT scans will be performed and 2 independent, calibrated operators will analyze the CBCT scans and mean bone values calculated. The distance from the nasopalatine canal to the center of each implant will be determined (4 different locations per patient, corresponding to implants 14; 11; 21; 24) and it will be the reference to other CBCTs. Implant length will be measured, from the neck (site 1) to the top and then a middle point will be assessed (site 2). Post-Surgical Volume (mm) will be determined from the most palatal point of cortical bone until the most buccal regenerated bone in each CBCT. Regenerated bone gain (mm) at post-op and at 1-year CBCTs will be calculated by the difference between pre and post-op or pre-op and 1 year CBCT measures, respectively. Regenerated Bone stability (%), defined as the percentage of regenerated bone at 12 months, will be calculated as the comparison between CBCT immediately after surgery and the CBCT at 12 months. Results will be presented as mean, with 95% CI.
Read the detailed description
Patients with maxillary atrophy and loss of lip support are often a challenge in terms of prosthodontic rehabilitation and surgical approach due to the aesthetic changes and bone availability for implant placement.
In edentulous patients, with severe maxillary atrophy and an obvious loss of lip support, the anterior maxilla commonly exhibits a thin buccal bone plate which requires horizontal bone augmentation, since various authors have mentioned that a minimum 2mm of facial bone is required to prevent vertical bone resorption.
The scientific literature describes several techniques for these cases (such as collagen or titanium membranes, non-resorbable pins, use of xenografts, allografts or autogenous bone) but still, none is considered as the gold standard.
The simultaneous approach, where implant placement is coincident with graft procedures, is preferred by both patients and clinicians, since it reduces treatment time and cost. However, it can't be applied in every case, due to the need of proper implant stability.
A significant clinical interest has grown regarding the use of L-PRF for regeneration, solely or in combination with xenografts, given its ease of protocol preparation, economic advantages, less invasive technique (no need for donor sites) and biological properties. Also, L-PRF has been used around immediately placed implants to restore the anatomy loss and to speed up soft tissue wound healing. However, the use of enough L-PRF membranes seems to be crucial to obtain an optimal effect.
For this reason, the use of a Guided bone regeneration with L-PRF in the Atrophic Maxilla (GLAM) technique is suggested as a surgical approach in patients with maxillary atrophy and evident loss of lip support, where Guided bone regeneration is performed with the use of L-PRF membranes and xenograft to restore the buccal bone volume of the Atrophic Maxilla, simultaneously to implant placement.
Aim: The purpose of this clinical trial is to evaluate the dimensional changes in the aesthetic zone of resorbed maxillae (based on CBCT scans) occurred 12 months after implant placement and simultaneous regeneration with the GLAM technique.
SURGICAL PROTOCOL: At the beginning of each surgery, a venipuncture will be performed, and blood will be drawn into red topped tubes (BD Vacutainer ®, 10mL) and centrifuged at 2700 rpm (IntraSpin™ Centrifuge, Intra-Lock ®) for 12 minutes to obtain the L-PRF membranes. Also, two white topped tubes (BD Vacutainer ®, 9mL) will be centrifuged for 3 minutes to obtain PRP. Both L-PRF membranes and PRP will be prepared according to previously described protocols. After implant placement, achieving a primary stability of at least 45 Ncm, the stiff bone-block (L-PRF membranes and PRP combined with bovine xenograft) will be used in the buccal plate of the pre-maxilla, to enhance bone volume in the esthetic area. After handling and positioning the bone block, a minimum of 3 layers of L-PRF membranes will be placed over the graft, in order to enhance the soft tissue healing. In cases where primary closure is not achievable, the top layer of the membranes will be left exposed.
CBCT ANALYSIS: Pre-op, post-op and 12 months' follow-up CBCT scans will be performed. Two independent, calibrated operators will analyze the CBCT scans and mean values will be calculated.
The distance from the nasopalatine canal to the center of each anterior implant will be determined in the post-op CBCT, in the panoramic perspective, and this will be the reference value to the other CBCTs. Four different locations will be determined per patient, in the anterior region of the maxilla, delimited by the anterior border of the maxillary sinus. These locations corresponded to the former lateral incisors and first pre-molars positions.
In sagittal cuts of the CBCT, the implant length will be measured, from the neck (site 1) to the top. Afterwards, a middle point will be assessed (site 2). These sites are the reference for measurements of bone volume in all the CBCT scans. Both sites correspond to the most grafted areas of the implants when restoring the lip support, thus more susceptible to dimensional changes. The apical third of the implant is responsible for the palatal bone anchorage.
Considering the CBCT scans, the following variables will be measured in both sites 1 and 2:
Post-Surgical Volume (mm): determined from the most palatal point of cortical bone until the most buccal point of regenerated bone, perpendicular to the implant's long axis.
Regenerated Bone Gain (mm): measured at the post-op and the 12 months CBCT scans from the most palatal point of cortical bone until the most buccal point of regenerated bone, perpendicular to the implant's long axis. Calculated by the difference between pre and post-op CBCTs (regenerated bone gain at post-op) and by the difference between pre-op and 12 months CBCT measures (regenerated bone gain at 12 months).
Regenerated Bone Stability (%): defined as the percentage of regenerated bone at 12 months, compared to immediately after surgery.
The results will be presented as mean, with 95% CI. Paired or independent Student's t-Test or ANOVA were used in this analysis. Post hoc tests will be used as appropriate, and Alpha will be set at 0.05.
- Conditions
- Bone Regeneration
- Being tested
- Bone Regeneration with GLAM technique
- Keywords
- Maxilary atrophy, Leucocyte-platelet-rich-fibrin, bone resorption, autologous growth factors, guided-bone-regeneration, lip support
- Medical subject headings
- Bone Resorption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone Regeneration with GLAM techniqueProcedure or surgery
Bone regeneration with GLAM technique in full arch implant supported rehabilitation
| Study group | Role | What they receive |
|---|---|---|
| Bone Regeneration with GLAM technique | Experimental | At the beginning of each surgery, a venipuncture will be performed, to obtain the L-PRF membranes. Also, two white topped tubes will be centrifuged for 3 minutes to obtain PRP. After implant placement, achieving a primary stability of at least 45 Ncm, the stiff bone-block (L-PRF membranes and PRP combined with bovine xenograft) will be used in the buccal plate of the pre-maxilla, to enhance bone volume in the esthetic area. Receives: Procedure: Bone Regeneration with GLAM technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Regenerated Bone Gain (mm)
Measured at the post-op and the 12 months CBCT scans from the most palatal point of cortical bone until the most buccal point of regenerated bone, perpendicular to the implant's long axis. Calculated by the difference between pre and post-op CBCTs (regenerated bone gain at post-op) and by the difference between pre-op and 12 months CBCT measures (regenerated bone gain at 12 months).
Measured: Pre-surgery, Baseline (0 days) and 12 month follow-up
Secondary outcomes (2)
Regenerated Bone Stability (%)
defined as the percentage of regenerated bone at 12 months, compared to immediately after surgery
Measured: Baseline (0 days) and 12 month follow-up
Post-Surgical Regenerated Bone Volume (mm)
determined from the most palatal point of cortical bone until the most buccal point of regenerated bone, perpendicular to the implant's long axis
Measured: Baseline (0 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2018
- Study startJan 2015
- Primary completionDec 2017
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone RegenerationStudies 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
- Model description
- To describe the dimensional changes (based on CBCT scans) occurred 12 months after implant placement and simultaneous regeneration with L-PRF and bovine bone graft in the aesthetic zone of atrophic maxillae in full arch implant supported rehabilitations
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Implantology Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Duarte Marques, DDS, PhD, Principal investigator, Implantology InstituteJoão Caramês, DDS, PhD, Study director, Implantology Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03391258
- Sponsor's protocol ID
- II2015-06
- Status last verified
- Aug 2018
- First submitted
- 22 Dec 2017
- Last updated
- 13 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Guided Bone Regeneration With L-PRF in the Atrophic Maxilla - A Pilot Clinical Trial
- ClinicalTrials.gov ID
- NCT03391258
- Acronym / sponsor ID
- II2015-06
- Conditions
- Bone Regeneration
- Keywords
- Maxilary atrophy, Leucocyte-platelet-rich-fibrin, bone resorption, autologous growth factors, guided-bone-regeneration, lip support
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Implantology InstituteUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 5 Jan 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.
16 patients with severe resorbed maxillae referred to Implantology Institute® will be submitted to full arch surgery, with simultaneous implant placement and regeneration in the aesthetic zone, with the GLAM technique.
Informed consents and local ethical committee clearance will be obtained. Pre, post and 12 months' follow-up CBCT scans will be performed and 2 independent, calibrated operators will analyze the CBCT scans and mean bone values calculated. The distance from the nasopalatine canal to the center of each implant will be determined (4 different locations per patient, corresponding to implants 14; 11; 21; 24) and it will be the reference to other CBCTs. Implant length will be measured, from the neck (site 1) to the top and then a middle point will be assessed (site 2). Post-Surgical Volume (mm) will be determined from the most palatal point of cortical bone until the most buccal regenerated bone in each CBCT. Regenerated bone gain (mm) at post-op and at 1-year CBCTs will be calculated by the difference between pre and post-op or pre-op and 1 year CBCT measures, respectively. Regenerated Bone stability (%), defined as the percentage of regenerated bone at 12 months, will be calculated as the comparison between CBCT immediately after surgery and the CBCT at 12 months. Results will be presented as mean, with 95% CI.
Detailed description
Patients with maxillary atrophy and loss of lip support are often a challenge in terms of prosthodontic rehabilitation and surgical approach due to the aesthetic changes and bone availability for implant placement.
In edentulous patients, with severe maxillary atrophy and an obvious loss of lip support, the anterior maxilla commonly exhibits a thin buccal bone plate which requires horizontal bone augmentation, since various authors have mentioned that a minimum 2mm of facial bone is required to prevent vertical bone resorption.
The scientific literature describes several techniques for these cases (such as collagen or titanium membranes, non-resorbable pins, use of xenografts, allografts or autogenous bone) but still, none is considered as the gold standard.
The simultaneous approach, where implant placement is coincident with graft procedures, is preferred by both patients and clinicians, since it reduces treatment time and cost. However, it can't be applied in every case, due to the need of proper implant stability.
A significant clinical interest has grown regarding the use of L-PRF for regeneration, solely or in combination with xenografts, given its ease of protocol preparation, economic advantages, less invasive technique (no need for donor sites) and biological properties. Also, L-PRF has been used around immediately placed implants to restore the anatomy loss and to speed up soft tissue wound healing. However, the use of enough L-PRF membranes seems to be crucial to obtain an optimal effect.
For this reason, the use of a Guided bone regeneration with L-PRF in the Atrophic Maxilla (GLAM) technique is suggested as a surgical approach in patients with maxillary atrophy and evident loss of lip support, where Guided bone regeneration is performed with the use of L-PRF membranes and xenograft to restore the buccal bone volume of the Atrophic Maxilla, simultaneously to implant placement.
Aim: The purpose of this clinical trial is to evaluate the dimensional changes in the aesthetic zone of resorbed maxillae (based on CBCT scans) occurred 12 months after implant placement and simultaneous regeneration with the GLAM technique.
SURGICAL PROTOCOL: At the beginning of each surgery, a venipuncture will be performed, and blood will be drawn into red topped tubes (BD Vacutainer ®, 10mL) and centrifuged at 2700 rpm (IntraSpin™ Centrifuge, Intra-Lock ®) for 12 minutes to obtain the L-PRF membranes. Also, two white topped tubes (BD Vacutainer ®, 9mL) will be centrifuged for 3 minutes to obtain PRP. Both L-PRF membranes and PRP will be prepared according to previously described protocols. After implant placement, achieving a primary stability of at least 45 Ncm, the stiff bone-block (L-PRF membranes and PRP combined with bovine xenograft) will be used in the buccal plate of the pre-maxilla, to enhance bone volume in the esthetic area. After handling and positioning the bone block, a minimum of 3 layers of L-PRF membranes will be placed over the graft, in order to enhance the soft tissue healing. In cases where primary closure is not achievable, the top layer of the membranes will be left exposed.
CBCT ANALYSIS: Pre-op, post-op and 12 months' follow-up CBCT scans will be performed. Two independent, calibrated operators will analyze the CBCT scans and mean values will be calculated.
The distance from the nasopalatine canal to the center of each anterior implant will be determined in the post-op CBCT, in the panoramic perspective, and this will be the reference value to the other CBCTs. Four different locations will be determined per patient, in the anterior region of the maxilla, delimited by the anterior border of the maxillary sinus. These locations corresponded to the former lateral incisors and first pre-molars positions.
In sagittal cuts of the CBCT, the implant length will be measured, from the neck (site 1) to the top. Afterwards, a middle point will be assessed (site 2). These sites are the reference for measurements of bone volume in all the CBCT scans. Both sites correspond to the most grafted areas of the implants when restoring the lip support, thus more susceptible to dimensional changes. The apical third of the implant is responsible for the palatal bone anchorage.
Considering the CBCT scans, the following variables will be measured in both sites 1 and 2:
Post-Surgical Volume (mm): determined from the most palatal point of cortical bone until the most buccal point of regenerated bone, perpendicular to the implant's long axis.
Regenerated Bone Gain (mm): measured at the post-op and the 12 months CBCT scans from the most palatal point of cortical bone until the most buccal point of regenerated bone, perpendicular to the implant's long axis. Calculated by the difference between pre and post-op CBCTs (regenerated bone gain at post-op) and by the difference between pre-op and 12 months CBCT measures (regenerated bone gain at 12 months).
Regenerated Bone Stability (%): defined as the percentage of regenerated bone at 12 months, compared to immediately after surgery.
The results will be presented as mean, with 95% CI. Paired or independent Student's t-Test or ANOVA were used in this analysis. Post hoc tests will be used as appropriate, and Alpha will be set at 0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- To describe the dimensional changes (based on CBCT scans) occurred 12 months after implant placement and simultaneous regeneration with L-PRF and bovine bone graft in the aesthetic zone of atrophic maxillae in full arch implant supported rehabilitations
| Arm | Type | Receives |
|---|---|---|
| Bone Regeneration with GLAM technique | Experimental | Procedure: Bone Regeneration with GLAM techniqueAt the beginning of each surgery, a venipuncture will be performed, to obtain the L-PRF membranes. Also, two white topped tubes will be centrifuged for 3 minutes to obtain PRP. After implant placement, achieving a primary stability of at least 45 Ncm, the stiff bone-block (L-PRF membranes and PRP combined with bovine xenograft) will be used in the buccal plate of the pre-maxilla, to enhance bone volume in the esthetic area. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ≥18years of age, ASA I or ASA II patients
Key exclusion criteria (1 listed)
- ASA III or ASA IV patients; uncontrolled diabetes, immunosuppressant medication, heavy smokers or pre-surgical infectious area next to the surgical site
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 |
|---|---|---|
| Bone Regeneration with GLAM techniqueBone regeneration with GLAM technique in full arch implant supported rehabilitation | Procedure or surgery | Bone Regeneration with GLAM technique |
Primary outcome
Changes in Regenerated Bone Gain (mm)
Time frame: Pre-surgery, Baseline (0 days) and 12 month follow-up
Measured at the post-op and the 12 months CBCT scans from the most palatal point of cortical bone until the most buccal point of regenerated bone, perpendicular to the implant's long axis. Calculated by the difference between pre and post-op CBCTs (regenerated bone gain at post-op) and by the difference between pre-op and 12 months CBCT measures (regenerated bone gain at 12 months).
2 secondary outcomes
Regenerated Bone Stability (%)
Time frame: Baseline (0 days) and 12 month follow-up
Post-Surgical Regenerated Bone Volume (mm)
Time frame: Baseline (0 days)
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 Aug 2018.
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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.
Duarte Marques, DDS, PhD principal investigator
Implantology Institute
João Caramês, DDS, PhD study director
Implantology Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bone Regeneration with GLAM technique in people with Bone Regeneration, run by Implantology Institute at 1 site in Portugal.
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 1 inclusion and 1 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 Aug 2018. 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 Portugal. 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?
Changes in Regenerated Bone Gain (mm) (time frame: Pre-surgery, Baseline (0 days) and 12 month follow-up). 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 Aug 2018.