LPRF Block vs. DBBM in Horizontal Bone Reconstruction
Horizontal Guided Bone Regeneration: LPRF Block vs. a Mixture of Autogenous Bone With Deproteinized Bovine Bone Mineral. A Split-mouth RCT Study With 25 Months Follow-up
연구 개요
상세 설명
12 patients were included in this split-mouth RCT. In test sites a horizontal GBR procedure was performed using a collagen membrane with a graft consisting of 50% autogenous bone and 50% DBBM. In control sites a collagen membrane was used, with a graft consisting of an LPRF block. This was left to heal for 9 months. Subsequently an implant was placed. At time of implant placement a bone biopsy was taken. After 4 months of osseointegration the abutment connection was performed. 1 year after loading of the implants a final check was done. CBCT scans were taken at intake, immediately after reconstruction, 9 months after reconstruction, before implant placement and 1 year after loading of the implants.
Primary outcome measure is the bone volume as measured on the CBCT scans. Secondary outcome measures are bone quality in the biopsy, buccal bone thickness around the oral implant, number and type of complications, cumulative survival rates of the implants 1 year after loading.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
Vlaams-Brabant
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Leuven, Vlaams-Brabant, 벨기에, 3000
- UZ Leuven
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Males or females, with ASA I or II, between 18 and 80 years old
- 2 implant sites requiring vertical bone augmentation prior to implant placement
- Both sites in the same jaw
- Good general health as documented by self-assessment
Exclusion Criteria:
- Any systemic medical condition that could interfere with the surgical procedure, planned treatment or healing of the patient
- Immunosuppression, Diabetes, Anticoagulation or Antiaggregatory medication.
- Current pregnancy or breast feeding/ lactating at the time of recruitment.
- Radiotherapy or Chemotherapy in head and neck area.
- Intravenous and oral bisphosphonate therapy.
- Smoking
- Unwillingness to return for the follow-up examination.
- Conditions or circumstances, in the opinion of the investigator, which could represent a general contra-indication for surgical procedure or would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance, or unrealistic expectations
- Presence of osseous pathologies, that might interfere with normal wound healing
- Presence of oral lesions (such as ulceration, malignancy)
- Local inflammation, including untreated periodontitis
- Patients with inadequate oral hygiene or unmotivated for adequate home care
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: LPRF block group
LPRF block covered by collagen membrane
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Bone grafting procedure using a particulated bone graft, covered by a resorbable membrane
다른 이름들:
|
|
실험적: Compound graft group
50% autogenous bone with 50% DBBM covered by collagen membrane.
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Bone grafting procedure using a particulated bone graft, covered by a resorbable membrane
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
bone volume changes
기간: at intake, immediately after surgery, 9 months postoperative, 13 months postoperative, 25 months postoperative
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bone volume is measured on CBCT scans of the jaw
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at intake, immediately after surgery, 9 months postoperative, 13 months postoperative, 25 months postoperative
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
buccal bone thickness on CBCT scan
기간: measured at placement of the implant and 1 year later
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thickness of the buccal bone plate of the oral implant
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measured at placement of the implant and 1 year later
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|
Cumulative survival rate of the implants
기간: measured at the 1 year loading follow-up
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survival of the implants over the follow-up time
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measured at the 1 year loading follow-up
|
|
Rates of complications
기간: from the gbr surgery to 25 months follow-up
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all possible complications were registered and monitored
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from the gbr surgery to 25 months follow-up
|
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
기타 연구 ID 번호
- S59813-1
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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