Alveolar Bone LossGBR-PRGF-MaxilNCT07654218
Guided Bone Regeneration Combined With PRGF for Atrophic Edentulous Maxilla
A study testing Guided Bone Regeneration Combined With Plasma Rich in Growth Factors in people with Alveolar Bone Loss and Edentulous Maxilla, Atrophic, run by Universidade do Porto at 1 site in Portugal.
Trial summary
This prospective interventional clinical study evaluated guided bone regeneration combined with plasma rich in growth factors for vertical and horizontal augmentation of the atrophic edentulous maxilla. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alveolar Bone Loss, Edentulous Maxilla, Atrophic, Alveolar Ridge Deficiency
- What is being tested?
- Guided Bone Regeneration Combined With Plasma Rich in Growth Factors
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Mar 2023to 31 Dec 2025
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Fully edentulous maxilla requiring implant-supported fixed oral rehabilitation
- Atrophic maxillary alveolar ridge requiring vertical and/or horizontal bone augmentation before implant placement
- Residual alveolar ridge width below 6 mm and/or residual bone height below 10 mm, as assessed by cone-beam computed tomography
- ASA physical status I or II
- Clinical indication for guided bone regeneration, with or without simultaneous maxillary sinus floor elevation
- Adequate oral hygiene and willingness to comply with postoperative instructions and follow-up visits
- Written informed consent provided.
Who cannot join
- ASA physical status III or higher
- Uncontrolled systemic disease contraindicating oral surgery or bone regenerative procedures
- Uncontrolled diabetes mellitus or other systemic condition expected to impair wound healing or bone regeneration
- History of radiotherapy to the head and neck region
- Current or previous intravenous antiresorptive or antiangiogenic therapy associated with risk of medication-related osteonecrosis of the jaw
- Active oral infection at the surgical site
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- Untreated periodontal disease or poor oral hygiene incompatible with regenerative surgery
- Heavy smoking or unwillingness to comply with perioperative smoking restrictions
- Pregnancy or breastfeeding
- Inability to understand the study procedures or provide informed consent
- Inability or unwillingness to attend scheduled follow-up visits
- Any medical, anatomical, or behavioural condition judged by the investigator to interfere with surgery, healing, follow-up, or interpretation of outcomes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Guided Bone Regeneration Combined With Plasma Rich in Growth Factors for Vertical and Horizontal Augmentation of the Atrophic Edentulous Maxilla: A Prospective Clinical Case Series With One-Year Follow-up
This prospective interventional clinical study evaluated guided bone regeneration combined with plasma rich in growth factors for vertical and horizontal augmentation of the atrophic edentulous maxilla.
Participants with severe maxillary ridge atrophy requiring bone augmentation before implant-supported rehabilitation underwent guided bone regeneration using a composite graft of autogenous bone and anorganic bovine bone mineral combined with plasma rich in growth factors. Barrier membranes were stabilised with titanium pins, and lateral-window sinus floor elevation was performed when indicated. Implants were placed using a delayed protocol at re-entry after 6-9 months.
Radiographic bone height and width were assessed by cone-beam computed tomography before surgery, immediately after surgery, at 6-9 months, and at 12 months. The study also recorded graft dimensional stability, implant placement, and surgical or postoperative complications.
Read the detailed description
Severe atrophy of the edentulous maxilla may limit fixed implant-supported rehabilitation because of insufficient residual alveolar ridge height and width. Guided bone regeneration is used to reconstruct deficient ridges before implant placement, while plasma rich in growth factors may provide an autologous fibrin matrix enriched with platelet-derived mediators.
This prospective clinical study assessed a guided bone regeneration protocol combined with plasma rich in growth factors for reconstruction of the atrophic edentulous maxilla. Eligible participants presented with an edentulous atrophic maxilla requiring vertical and/or horizontal ridge augmentation before implant placement. The surgical protocol included guided bone regeneration using a composite graft of autogenous bone and anorganic bovine bone mineral in a 60:40 ratio, combined with plasma rich in growth factors prepared from autologous blood. The grafted area was covered with a barrier membrane stabilised with titanium pins. Titanium-reinforced PTFE membranes were used for defects requiring vertical space maintenance, while collagen membranes were used for horizontal augmentations. Lateral-window sinus floor elevation was performed simultaneously when indicated by posterior maxillary anatomy.
Cone-beam computed tomography was obtained pre-surgically, immediately post-operatively, at 6-9 months, and at 12 months. Linear vertical and horizontal bone measurements were performed at three standardised maxillary reference sites: the lateral wall of the nasal cavity, the medial wall of the maxillary sinus, and the zygomatic apophysis. Bone gain was calculated in millimetres and as percentage change relative to the pre-surgical dimension. Graft resorption was calculated between the immediate post-operative and 12-month assessments. Implant placement and intraoperative or postoperative complications were also recorded.
- Being tested
- Guided Bone Regeneration Combined With Plasma Rich in Growth Factors
- Medical subject headings
- Alveolar Bone Loss, Atrophic Maxilla
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided Bone Regeneration Combined With Plasma Rich in Growth FactorsProcedure or surgery
Also called GBR + PRGF, Plasma Rich in Growth Factors, Vertical Ridge Augmentation, Horizontal Ridge Augmentation
Guided bone regeneration was performed for reconstruction of the atrophic edentulous maxilla. Autogenous bone harvested intra-orally was combined with anorganic bovine bone mineral in a 60:40 ratio and mixed with autologous plasma rich in growth factors. The grafted area was covered with a barrier membrane stabilised with titanium pins. Titanium-reinforced PTFE membranes were used for defects requiring vertical space maintenance, while collagen membranes were used for horizontal augmentations. Lateral-window sinus floor elevation was performed simultaneously when indicated. Implants were placed using a delayed protocol at re-entry after 6-9 months.
| Study group | Role | What they receive |
|---|---|---|
| GBR Combined With PRGF | Experimental | Participants with an atrophic edentulous maxilla requiring vertical and/or horizontal bone augmentation before implant-supported rehabilitation underwent guided bone regeneration combined with plasma rich in growth factors. The procedure used a composite graft of autogenous bone and anorganic bovine bone mineral combined with PRGF. Barrier membranes were stabilised with titanium pins, and simultaneous lateral-window sinus floor elevation was performed when clinically indicated. Receives: Procedure: Guided Bone Regeneration Combined With Plasma Rich in Growth Factors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Vertical and Horizontal Maxillary Bone Dimensions
Vertical and horizontal bone dimensions were measured using standardized cone-beam computed tomography at three maxillary reference sites: the lateral wall of the nasal cavity, the medial wall of the maxillary sinus, and the zygomatic apophysis. Bone gain was calculated in millimeters and as percentage change relative to the pre-surgical dimension.
Measured: Pre-surgery, immediately post-operative, 6-9 months, and 12 months
Secondary outcomes (3)
Graft Resorption
Graft resorption was calculated as the percentage change in vertical and horizontal bone dimensions between the immediate post-operative CBCT and the 12-month CBCT assessment.
Measured: Immediately post-operative to 12 months
Number of Dental Implants Placed
Number of dental implants placed during delayed implant placement at re-entry following guided bone regeneration.
Measured: 6-9 months after augmentation
Incidence of Surgical and Postoperative Complications
Intraoperative and postoperative complications were recorded, including infection, graft loss, membrane-related complications, and other adverse events. Complications were classified according to severity and whether they affected graft integrity.
Measured: From augmentation surgery to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study start1 Mar 2023
- Primary completion30 Nov 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar Bone LossStudies 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
- All participants were assigned to a single intervention group and underwent guided bone regeneration combined with plasma rich in growth factors for vertical and/or horizontal augmentation of the atrophic edentulous maxilla. Simultaneous lateral-window sinus floor elevation was performed when clinically indicated by posterior maxillary anatomy. No comparator or control group was included.
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade do Porto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07654218
- Sponsor's protocol ID
- 5/2022 FMDUP-PRGF
- Other IDs
- 5/2022
- Acronym
- GBR-PRGF-Maxil
- Status last verified
- Jun 2026
- First submitted
- 12 Jun 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be publicly shared because of the small sample size, the single-centre nature of the study, and the potential risk of participant re-identification from clinical, radiographic, and surgical data.
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Guided Bone Regeneration Combined With Plasma Rich in Growth Factors for Vertical and Horizontal Augmentation of the Atrophic Edentulous Maxilla: A Prospective Clinical Case Series With One-Year Follow-up
- ClinicalTrials.gov ID
- NCT07654218
- Acronym / sponsor ID
- GBR-PRGF-Maxil / 5/2022 FMDUP-PRGF
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Universidade do PortoUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 17 Jun 2026 (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.
This prospective interventional clinical study evaluated guided bone regeneration combined with plasma rich in growth factors for vertical and horizontal augmentation of the atrophic edentulous maxilla.
Participants with severe maxillary ridge atrophy requiring bone augmentation before implant-supported rehabilitation underwent guided bone regeneration using a composite graft of autogenous bone and anorganic bovine bone mineral combined with plasma rich in growth factors. Barrier membranes were stabilised with titanium pins, and lateral-window sinus floor elevation was performed when indicated. Implants were placed using a delayed protocol at re-entry after 6-9 months.
Radiographic bone height and width were assessed by cone-beam computed tomography before surgery, immediately after surgery, at 6-9 months, and at 12 months. The study also recorded graft dimensional stability, implant placement, and surgical or postoperative complications.
Detailed description
Severe atrophy of the edentulous maxilla may limit fixed implant-supported rehabilitation because of insufficient residual alveolar ridge height and width. Guided bone regeneration is used to reconstruct deficient ridges before implant placement, while plasma rich in growth factors may provide an autologous fibrin matrix enriched with platelet-derived mediators.
This prospective clinical study assessed a guided bone regeneration protocol combined with plasma rich in growth factors for reconstruction of the atrophic edentulous maxilla. Eligible participants presented with an edentulous atrophic maxilla requiring vertical and/or horizontal ridge augmentation before implant placement. The surgical protocol included guided bone regeneration using a composite graft of autogenous bone and anorganic bovine bone mineral in a 60:40 ratio, combined with plasma rich in growth factors prepared from autologous blood. The grafted area was covered with a barrier membrane stabilised with titanium pins. Titanium-reinforced PTFE membranes were used for defects requiring vertical space maintenance, while collagen membranes were used for horizontal augmentations. Lateral-window sinus floor elevation was performed simultaneously when indicated by posterior maxillary anatomy.
Cone-beam computed tomography was obtained pre-surgically, immediately post-operatively, at 6-9 months, and at 12 months. Linear vertical and horizontal bone measurements were performed at three standardised maxillary reference sites: the lateral wall of the nasal cavity, the medial wall of the maxillary sinus, and the zygomatic apophysis. Bone gain was calculated in millimetres and as percentage change relative to the pre-surgical dimension. Graft resorption was calculated between the immediate post-operative and 12-month assessments. Implant placement and intraoperative or postoperative complications were also recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants were assigned to a single intervention group and underwent guided bone regeneration combined with plasma rich in growth factors for vertical and/or horizontal augmentation of the atrophic edentulous maxilla. Simultaneous lateral-window sinus floor elevation was performed when clinically indicated by posterior maxillary anatomy. No comparator or control group was included.
| Arm | Type | Receives |
|---|---|---|
| GBR Combined With PRGF | Experimental | Procedure: Guided Bone Regeneration Combined With Plasma Rich in Growth FactorsParticipants with an atrophic edentulous maxilla requiring vertical and/or horizontal bone augmentation before implant-supported rehabilitation underwent guided bone regeneration combined with plasma rich in growth factors. The procedure used a composite graft of autogenous bone and anorganic bovine bone mineral combined with PRGF. Barrier membranes were stabilised with titanium pins, and simultaneous lateral-window sinus floor elevation was performed when clinically indicated. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18 years or older
- Fully edentulous maxilla requiring implant-supported fixed oral rehabilitation
- Atrophic maxillary alveolar ridge requiring vertical and/or horizontal bone augmentation before implant placement
- Residual alveolar ridge width below 6 mm and/or residual bone height below 10 mm, as assessed by cone-beam computed tomography
- ASA physical status I or II
Key exclusion criteria (12 listed)
- ASA physical status III or higher
- Uncontrolled systemic disease contraindicating oral surgery or bone regenerative procedures
- Uncontrolled diabetes mellitus or other systemic condition expected to impair wound healing or bone regeneration
- History of radiotherapy to the head and neck region
- Current or previous intravenous antiresorptive or antiangiogenic therapy associated with risk of medication-related osteonecrosis of the jaw
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 |
|---|---|---|
| Guided Bone Regeneration Combined With Plasma Rich in Growth FactorsAlso: GBR + PRGF, Plasma Rich in Growth Factors, Vertical Ridge Augmentation, Horizontal Ridge AugmentationGuided bone regeneration was performed for reconstruction of the atrophic edentulous maxilla. Autogenous bone harvested intra-orally was combined with anorganic bovine bone mineral in a 60:40 ratio and mixed with autologous plasma rich in growth factors. The grafted area was covered with a barrier membrane stabilised with titanium pins. Titanium-reinforced PTFE membranes were used for defects requiring vertical space maintenance, while collagen membranes were used for horizontal augmentations. Lateral-window sinus floor elevation was performed simultaneously when indicated. Implants were placed using a delayed protocol at re-entry after 6-9 months. | Procedure or surgery | GBR Combined With PRGF |
Primary outcome
Change in Vertical and Horizontal Maxillary Bone Dimensions
Time frame: Pre-surgery, immediately post-operative, 6-9 months, and 12 months
Vertical and horizontal bone dimensions were measured using standardized cone-beam computed tomography at three maxillary reference sites: the lateral wall of the nasal cavity, the medial wall of the maxillary sinus, and the zygomatic apophysis. Bone gain was calculated in millimeters and as percentage change relative to the pre-surgical dimension.
3 secondary outcomes
Graft Resorption
Time frame: Immediately post-operative to 12 months
Number of Dental Implants Placed
Time frame: 6-9 months after augmentation
Incidence of Surgical and Postoperative Complications
Time frame: From augmentation surgery to 12 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 9 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be publicly shared because of the small sample size, the single-centre nature of the study, and the potential risk of participant re-identification from clinical, radiographic, and surgical data.
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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 Guided Bone Regeneration Combined With Plasma Rich in Growth Factors in people with Alveolar Bone Loss and Edentulous Maxilla, Atrophic, run by Universidade do Porto 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 8 inclusion and 12 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 9 Sep 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 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?
Change in Vertical and Horizontal Maxillary Bone Dimensions (time frame: Pre-surgery, immediately post-operative, 6-9 months, and 12 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 9 Sep 2026.