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Completed

NCT Number: NCT07654218

Guided Bone Regeneration Combined With PRGF for Atrophic Edentulous Maxilla

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dental Medicine, University of Porto

Porto, Portugal

About this study

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.

Who can participate

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.

Treatment and study plan

Guided Bone Regeneration Combined With Plasma Rich in Growth Factors

Procedure

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Graft Resorption

    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.

  2. Number of Dental Implants Placed

    Time frame: 6-9 months after augmentation

    Number of dental implants placed during delayed implant placement at re-entry following guided bone regeneration.

  3. Incidence of Surgical and Postoperative Complications

    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.

Sponsors and collaborators

Lead sponsor

Universidade do Porto

Other

Registry information

Official study 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

Acronym: GBR-PRGF-Maxil

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jun 17, 2026
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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