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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
研究概览
简要总结
split-mouth RCT. 12 patients. horizontal GBR performed. 2 grafts were compared: test was LPRF block, control was 50% autogenous bone and 50% DBBM. 25 months follow-up.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
patient was not aware which side received which grafting material Outcome assessor was not awara which side received which grafting material.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
- •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
研究者
Ana CASTRO SARDA
prof. dr.
Universitaire Ziekenhuizen KU Leuven