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.
연구 개요
상태
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Porto, 포르투갈
- Faculty of Dental Medicine, university of Porto
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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.
|
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.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Vertical and Horizontal Maxillary Bone Dimensions
기간: Pre-surgery, immediately post-operative, 6-9 months, and 12 months
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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.
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Pre-surgery, immediately post-operative, 6-9 months, and 12 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Graft Resorption
기간: Immediately post-operative to 12 months
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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.
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Immediately post-operative to 12 months
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Number of Dental Implants Placed
기간: 6-9 months after augmentation
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Number of dental implants placed during delayed implant placement at re-entry following guided bone regeneration.
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6-9 months after augmentation
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Incidence of Surgical and Postoperative Complications
기간: From augmentation surgery to 12 months
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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.
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From augmentation surgery to 12 months
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 5/2022 FMDUP-PRGF
- 5/2022 (기타 식별자: Ethics Committee for Health of the Faculty of Dental Medicine, U. Porto)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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