Bone Microarchitecture and Implant Stabilization in Atrophic Jaws Reconstructed With Bone Grafts Treated With Teriparatide
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Histology
研究概览
简要总结
The aim of this triple blind randomized controlled trial will be to analyze the effect of a dose of teriparatide combined with a xenograft on bone augmentation of the maxillary sinus, to observe the microarchitecture of the newly formed bone and the primary and late stability of implants placed on these grafts. The sample is composed of 42 participants who have a clinical indication for maxillary sinus floor augmentation with bone grafting due to residual bone height less than or equal to 5mm for the installation of dental implants. Each side will be grafted with Bio-Oss® or Bio-Oss® combined with 1 dose (20 µg) of teriparatide (Forteo®). Three months after grafting, at the time of placement of dental implants, bone biopsies will be obtained using a short 2mm trephine bur. These bone cores will be submitted to histological and histomorphometric analysis. The stability of the implants will be measured, at the time of their installation, through the insertion torque, and through the use of resonance frequency equipment (Ostell®) in three moments: immediately and at 3 and 6 months after the installation of the dental implants.
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, Investigator)
入排标准
- 年龄范围
- 25 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Pneumatization of a maxillary sinus with a residual ridge ≤ 5 mm in height (according to baseline conebeam tomograph).
- •Must sign an informed consent to participate in this study.
排除标准
- •Residual ridges less than 4 mm in height.
- •Uncontrolled systemic disease (ASA 3, 4, 5, and 6)
- •Presenting with osteoporosis or any disease of bone metabolism.
- •Having received radiotherapy.
- •Any systemic condition that affects calcium absorption.
- •Kidney disease.
- •Coagulation disorders.
- •History of sinusitis.
- •Maxillary sinus pathology.
- •Heavy smoking (> 1 pack per day).
- •Drug or alcohol users.
- •Pregnancy.
- •Treatment with drugs that affect bone metabolism.
- •Treatment with immunosuppressants.
- •Allergies.
- •Uncontrolled periodontal pathology.
- •Tooth extractions in the last three months.
研究组 & 干预措施
Teriparatide
Access to the maxillary sinus will be done through osteotomy, using a piezosurgery . Subsequently, the Schneider's membrane will be carefully lifted and, according to the randomization process, the graft material Bio-Oss® mixed with Forteo® will be delivered for placement on the sinus floor maxilla below Schneider's membrane.
Next, the access window to the maxillary sinus and Schneider's membrane will be protected. The mucoperiosteal flap will be repositioned and closed
干预措施: Teriparatide (Drug)
Teriparatide
Access to the maxillary sinus will be done through osteotomy, using a piezosurgery . Subsequently, the Schneider's membrane will be carefully lifted and, according to the randomization process, the graft material Bio-Oss® mixed with Forteo® will be delivered for placement on the sinus floor maxilla below Schneider's membrane.
Next, the access window to the maxillary sinus and Schneider's membrane will be protected. The mucoperiosteal flap will be repositioned and closed
干预措施: Maxillary Sinus Augmentation (Procedure)
Teriparatide
Access to the maxillary sinus will be done through osteotomy, using a piezosurgery . Subsequently, the Schneider's membrane will be carefully lifted and, according to the randomization process, the graft material Bio-Oss® mixed with Forteo® will be delivered for placement on the sinus floor maxilla below Schneider's membrane.
Next, the access window to the maxillary sinus and Schneider's membrane will be protected. The mucoperiosteal flap will be repositioned and closed
干预措施: Dental Implant Installation (Procedure)
Teriparatide
Access to the maxillary sinus will be done through osteotomy, using a piezosurgery . Subsequently, the Schneider's membrane will be carefully lifted and, according to the randomization process, the graft material Bio-Oss® mixed with Forteo® will be delivered for placement on the sinus floor maxilla below Schneider's membrane.
Next, the access window to the maxillary sinus and Schneider's membrane will be protected. The mucoperiosteal flap will be repositioned and closed
干预措施: Bone graft (Combination Product)
Placebo
Access to the maxillary sinus will be done through osteotomy, using a piezosurgery . Subsequently, the Schneider's membrane will be carefully lifted and, according to the randomization process, the graft material, Bio-Oss® mixed with saline solution, will be delivered for placement on the sinus floor maxilla below Schneider's membrane.
Next, the access window to the maxillary sinus and Schneider's membrane will be protected. The mucoperiosteal flap will be repositioned and closed
干预措施: Maxillary Sinus Augmentation (Procedure)
Placebo
Access to the maxillary sinus will be done through osteotomy, using a piezosurgery . Subsequently, the Schneider's membrane will be carefully lifted and, according to the randomization process, the graft material, Bio-Oss® mixed with saline solution, will be delivered for placement on the sinus floor maxilla below Schneider's membrane.
Next, the access window to the maxillary sinus and Schneider's membrane will be protected. The mucoperiosteal flap will be repositioned and closed
干预措施: Dental Implant Installation (Procedure)
Placebo
Access to the maxillary sinus will be done through osteotomy, using a piezosurgery . Subsequently, the Schneider's membrane will be carefully lifted and, according to the randomization process, the graft material, Bio-Oss® mixed with saline solution, will be delivered for placement on the sinus floor maxilla below Schneider's membrane.
Next, the access window to the maxillary sinus and Schneider's membrane will be protected. The mucoperiosteal flap will be repositioned and closed
干预措施: Bone graft (Combination Product)
结局指标
主要结局
Histology
时间窗: 3 months
osteoblasts/mm2
次要结局
- Histomorphometry(3 months)