Guided Bone Regeneration Combined With PRGF for Atrophic Edentulous Maxilla (GBR-PRGF-Maxil)

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.

Study Overview

• Status: Completed
• Conditions: Alveolar Bone Loss; Alveolar Ridge Deficiency; Edentulous Maxilla, Atrophic; Jaw Atrophy
• Intervention / Treatment: Procedure: Guided Bone Regeneration Combined With Plasma Rich in Growth Factors

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 Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Portugal
  • Porto, Portugal
    • Faculty of Dental Medicine, University of Porto

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: GBR Combined With PRGF; 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.

Procedure: Guided 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.; Other Names: GBR + PRGF; Plasma Rich in Growth Factors; Vertical Ridge Augmentation; Horizontal Ridge Augmentation; Alveolar Ridge Augmentation; Sinus Floor Elevation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Pre-surgery, immediately post-operative, 6-9 months, and 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	From augmentation surgery to 12 months

Collaborators and Investigators

• Sponsor: Universidade do Porto

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Actual): November 30, 2025
• Study Completion (Actual): December 31, 2025

Study Registration Dates

• First Submitted: June 12, 2026
• First Submitted That Met QC Criteria: June 12, 2026
• First Posted (Actual): June 17, 2026

Study Record Updates

• Last Update Posted (Actual): June 17, 2026
• Last Update Submitted That Met QC Criteria: June 12, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Jaw Diseases; Maxillary Diseases; Alveolar Bone Loss; Atrophic Maxilla; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Surgical Procedures, Operative; Biological Factors; Dentistry; Oral Surgical Procedures; Oral Surgical Procedures, Preprosthetic; Intercellular Signaling Peptides and Proteins; Alveolar Ridge Augmentation
• Other Study ID Numbers: 5/2022 FMDUP-PRGF; 5/2022 (Other Identifier: Ethics Committee for Health of the Faculty of Dental Medicine, U. Porto)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No