Double-blind Randomized Controlled Clinical Study of the Predictability of Using Plenum® Osshp in Maxillary Sinus Elevation Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- M3 Health
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Rate of the maintenance of volume in the maxillary sinus region.
研究概览
简要总结
The aim of this study is to qualitatively and quantitatively evaluate bone neoformation in maxillary sinus lift surgery filled with Plenum® Oss hp, compared to filling with autogenous bone, and to verify the association of Plenum® Osshp with i-PRF (i-PR - injectable platelet-rich fibrin). For this, forty (40) participants will be recruited, divided into 4 groups, which will have 10 participants each, namely: Group 1: Autogenous bone; Group 2: Plenum® Osshp; Group 3: Plenum® Osshp; + i-PRF and Group 4: Plenum® Osshp; + autogenous bone. To evaluate the primary outcome, volumetric analysis will be performed by obtaining computed tomography scans at 15 days (T1) and 6 months (T2) after graft surgery, with the aid of a volumetric tomography machine for dentofacial images. The values obtained at T2 will be subtracted from those obtained from T1 to obtain the volumetric stability value. After six months of repair, biopsies will be performed using a trephine drill, followed by the installation of implants and healers. Through microcomputed tomography analysis, the parameters of bone volume fraction (BV/TV), total porosity (Po.Tot), trabecular thickness (Tb.Th), number of trabeculae (Tb.N) and separation of trabeculae (Tb.Sp) will be evaluated. Histomorphometric analysis will be performed to obtain the areas of bone neoformation, connective tissue and remaining biomaterial that will be calculated for each area of the sample (cervical, intermediate, and apical) and later summed, obtaining the total representative area of the sample. Through immunohistochemical analysis, specific primary antibodies to Runx2, VEGF, Osteocalcin (OC) and Tartrate-Resistant Acid Phosphatase (TRAP) will be identified. The occurrence of adverse events will be collected through the analysis of pain, infection, and edema. The quantitative results of the histomorphometric, microtomographic, and volumetric stability analysis will be tabulated and submitted to the ANOVA test, and if they present a statistically significant difference, it will be followed by the Tukey test (post hoc). A significance level of p<0.05 will be adopted for all tests.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with alveolar ridge atrophy, with bone remnant less than 5 mm in height, with adequate bone volume in the ramus and/or symphysis region;
- •Over 18 years old;
- •And that they have signed the informed consent form.
排除标准
- •Patients with uncontrolled systemic diseases;
- •Patients with blood dyscrasias;
- •Patients with sinus pathologies;
- •Patients who take or have used medications that interfere with bone turnover;
- •Patients irradiated in the head and neck region;
- •Pregnant patients;
- •Patients with untreated periodontal disease.
结局指标
主要结局
Rate of the maintenance of volume in the maxillary sinus region.
时间窗: Fifteen days (T1) and six months (T2) from postoperative.
Computed tomography scans were performed and compared after graft surgery (T1) and after 6 months of repair (T2). The maintenance of the volume will be defined by the difference in the area of T2-T1.
次要结局
- Rate of the bone neoformation of the synthetic graft in comparison with the autogenous graft and in association with i-PRF.(Six months from postoperative.)
- Rate of influence of the use of synthetic grafts on newly formed bone tissue, in comparison with autogenous grafts and in association with i-PRF.(Six months from postoperative.)
- Rate of the areas of bone neoformation, connective tissue and remnant synthetic graft.(Six months from postoperative.)