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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Portugal1 site
  • Instituto de Implantologia

    Lisbon, 1070-064

Other trials in Portugal

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.

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 groups in NCT03391258
Study groupRoleWhat they receive
Bone Regeneration with GLAM techniqueExperimentalAt 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.

  1. 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)
  1. 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

  2. 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.

  1. First posted5 Jan 2018
  2. Study startJan 2015
  3. Primary completionDec 2017
  4. Study completionMar 2018

Resources

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)
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

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.

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