Alveolar Bone Loss, Alveolar Ridge Deficiency, Edentulous Maxilla, Atrophic, Jaw Atrophy
Conditions
Brief 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. 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.
Interventions
PROCEDUREGuided Bone Regeneration Combined With Plasma Rich in Growth Factors
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.
Sponsors
Universidade do Porto
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Vertical and Horizontal Maxillary Bone Dimensions | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Graft Resorption | 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. |
| Number of Dental Implants Placed | 6-9 months after augmentation | Number of dental implants placed during delayed implant placement at re-entry following guided bone regeneration. |
| Incidence of Surgical and Postoperative Complications | 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. |
Countries
Portugal
Outcome results
None listed