Faculty of Dental Medicine, University of Porto
Porto, Portugal
NCT Number: NCT07654218
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Porto, Portugal
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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.
Exclusion criteria
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. 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.
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.
Other names: GBR + PRGF, Plasma Rich in Growth Factors, Vertical Ridge Augmentation, Horizontal Ridge Augmentation, Alveolar Ridge Augmentation, Sinus Floor Elevation
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.
Time frame: Immediately post-operative to 12 months
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.
Time frame: 6-9 months after augmentation
Number of dental implants placed during delayed implant placement at re-entry following guided bone regeneration.
Time frame: From augmentation surgery to 12 months
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.
Universidade do Porto
Other
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
Acronym: GBR-PRGF-Maxil
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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