Sinus Lift Grafting With Anorganic Bovine Bone vs 50% Autologous + 50% Bovine Bone. One Year Results From a Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- IMPLANT SURVIVAL
研究概览
简要总结
Background: Maxillary sinus floor augmentation is a standard surgical procedure to increase bone height in the atrophic posterior maxilla for dental implant placement. In bone reconstructive surgery, in general, autogenous bone is considered as the gold standard, primarily due to its osteogenic potential and remodelling capacity. Bone substitutes are available that can overcome the limitations of autologous bone due to their osteoconductive properties and biocompatibility. Several studies seem to validate these concepts, but further comparative trials are needed.
Aim: To compare the outcome of implants inserted in maxillary sinuses augmented with bovine bone grafts vs 50% bovine bone graft and 50% autologous bone according to a lateral approach.
Material and Methods: This study was designed as a randomised, controlled, clinical trial. Sixteen partially or fully edentulous patients, 20 sinuses, (four patients have been bilaterally treated) having 1 to 4 mm of residual crestal height below the maxillary sinuses were randomised according to a parallel group design. Sinuses were grafted according to a lateral approach. Group A (10 sinuses) was grafted with 50% anorganic bovine bone (Bio-Oss) and 50% autogenous bone, group B (10 sinuses) was grafted with 100% anorganic bovine bone (Bio-Oss). According with a two stages approach, after 7 months a total of 32 implants (Nobel Replace tapered groovy) were inserted with an insertion torque between 35 and 45 Ncm. At same surgical procedure a sample of bone was harvested for histomorphometric analysis . All implants were delayed loaded with screw retained temporary crowns 3 months after implants insertion and with screw retained definitive crowns 4 months later. Outcome measures were implant survival, biological and prosthetic complications, radiographic marginal bone-level changes, PPD and BOP. Clinical data were collected at baseline 6,12 months. Statistical significance was tested at the 0.05 probability level, and all values were presented as mean and standard deviation.
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Need for implant-supported prosthesis in maxillary posterior area.
- •Need to insert implant in atrophic posterior maxilla, with a residual alveolar bone height 1 4 mm.
- •≥ 18 years of age.
- •Provided written informed consent.
- •Smokers of fewer than 10 cigarettes per day.
- •Absence of sinus cyst or active sinusitis.
排除标准
- •General contraindications to implant surgery.
- •Occluding dentition in the area intended for implant installation
- •Periodontitis.
- •Immunosuppression.
- •Previous history of irradiation of the head and neck area.
- •Uncontrolled diabetes.
- •Heavy smoker (>10 cigarettes/day).
- •Poor oral hygiene.
- •Current or past treatment with bisphosphonates.
- •Substance abuse.
- •Psychiatric disorder.
- •Inability to complete follow-up ≥1 year.
- •Lactation.
结局指标
主要结局
IMPLANT SURVIVAL
时间窗: up to 12 months
The removal of implants was dictated by instability, progressive marginal bone loss, infection, or implant fracture. The stability of individual implants was measured by the prosthodontist at the time of definitive crown delivery (5 months after implant placement) by applying 35 Ncm of removal torque. After 1 year, implant stability was tested manually with two dental mirror handles.
次要结局
- MARGINAL BONE LEVELS(Baseline, 12 months)
研究者
Silvio Mario Meloni
DDS, Phd, MS
Università degli Studi di Sassari