Guided Bone Regeneration Combined With PRGF for Atrophic Edentulous Maxilla

NCT07654218 | Completed DMC

• 2 other identifiers: 5/2022 FMDUP-PRGF5/2022
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Alveolar Bone Loss; Edentulous Maxilla, Atrophic; Alveolar Ridge Deficiency; Jaw Atrophy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Graft Resorption

  Immediately post-operative to 12 months

• Number of Dental Implants Placed

  6-9 months after augmentation

• Incidence of Surgical and Postoperative Complications

  From augmentation surgery to 12 months

Study Arms (1)

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.

Procedure: Guided Bone Regeneration Combined With Plasma Rich in Growth Factors

Interventions

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.

Also known as: GBR + PRGF, Plasma Rich in Growth Factors, Vertical Ridge Augmentation, Horizontal Ridge Augmentation, Alveolar Ridge Augmentation, Sinus Floor Elevation

GBR Combined With PRGF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade do Porto: lead

Study Sites (1)

Faculty of Dental Medicine, University of Porto

Porto, Portugal

Location

MeSH Terms

Conditions

Alveolar Bone Loss; Atrophic Maxilla

Interventions

Intercellular Signaling Peptides and Proteins; Alveolar Ridge Augmentation

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Maxillary Diseases; Jaw Diseases

Intervention Hierarchy (Ancestors)

Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Oral Surgical Procedures, Preprosthetic; Oral Surgical Procedures; Surgical Procedures, Operative; Dentistry

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 12, 2026
• First Posted: June 17, 2026
• Study Start: March 1, 2023
• Primary Completion: November 30, 2025
• Study Completion: December 31, 2025
• Last Updated: June 17, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)