Guided Bone Regeneration Combined With PRGF for Atrophic Edentulous Maxilla (NCT07654218) | Clinical Trial Compass
CompletedNot Applicable
Guided Bone Regeneration Combined With PRGF for Atrophic Edentulous Maxilla
Portugal11 participantsStarted 2023-03-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Vertical and Horizontal Maxillary Bone Dimensions
Timeframe: Pre-surgery, immediately post-operative, 6-9 months, and 12 months