Clinical, Radiological and Histological Comparison of the Use of Bovine Bone Graft and Titanium-Platelet Rich Fibrin in Maxillary Sinus Augmentation: Split-Mouth Randomized Controlled Trials
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Histomorphometric bone changes
研究概览
简要总结
Before placement of the dental implant in the posterior maxilla where the maxillary sinus is pneumatized, it is necessary to elevate of the sinus mucosa from the sinus floor (sinus lift) and to provide new bone formation by using bone-forming graft materials (maxillary sinus augmentation) in the space obtained. In the bilateral maxillary posterior region with insufficient bone height with tooth deficiency, two-stage sinus lift and placement of platelet-rich fibrin prepared with titanium on one side and bovine bone graft on the other side in the implant surgery will affect the primary stability of the implant, the obtained bone histology, volume, height and density is the evaluation of its effect on it. Ten patients who required a maxillary sinus augmentation procedure for implant placement in the bilateral atrophic maxilla were included. Bio-Oss bovine bone graft was made on one side of the patients and randomly assigned to the control group, and the other side was randomly assigned to the test group using platelet-rich fibrin prepared with titanium.
详细描述
In addition to insufficient bone height with bone resorption of the posterior maxilla after tooth loss, the pneumatization of the maxillary sinus is one of the factors that prevent implant placement in the posterior maxilla. For this, it is necessary to raise the sinus mucosa from the sinus floor (sinus lift) and to provide new bone formation by using bone graft materials (maxillary sinus augmentation) in the resulting sinüs cavity. Two-stage sinus augmentation and implant placement have been recognized as a good clinical model for evaluating the performance of graft materials. Because bone formation takes place in a closed area and with minimal intervention of external factors. Platelet-rich fibrin (T-PRF) prepared with titanium from autologous thrombocyte concentrates showed a tighter polymerized fibrin structure and a long dissolution process, and it was reported that new bone formation started on the 15th day with the placed T-PRF and was effective in 30 days. In a study, comparing the use of allograft and T-PRF in maxillary sinus augmentation, the group in which only T-PRF was applied showed successful clinical and histological results, and new bone formation was accelerated up to 4 months compared to allografts. The primary stability of the implants placed was similar in both groups.
The primary stability of the implant, the bone histology, volume, height and density of the two-stage sinus lift in the bilateral maxillary posterior region with insufficient bone height with tooth deficiency, and the placement of platelet-rich fibrin prepared with titanium on one side and bovine bone graft on the other side in implant surgery, evaluation of its effect.
Bilateral atrophic maxilla dental implant placement and who needed maxillary sinus augmentation, and who did not smoke or smoked at most 10 cigarettes will be included in the study. Before the operation, systemic and dental anamnesis will be taken from the patient and clinical measurements and radiographic images will be recorded.
Inclusion criteria
- be over 18 years old
- The patient does not have any systemic disease
- Patients who do not smoke or smoke less than 10 times a day
- Patients who need fixed implant supported prosthesis in the bilateral maxillary posterior region
- Bilateral posterior maxilla residual bone height <5 mm on current radiographs
- Full mouth plaque insertion and bleeding score ≤15%
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 (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •>18 years old
- •The patient does not have any systemic disease
- •Patients who need fixed implant-supported prosthesis in the bilateral maxillary posterior region
- •Bilateral posterior maxilla residual bone height <5 mm
- •Full mouth plaque and bleeding score ≤15%
排除标准
- •Patients who smoke more than 10 cigarettes a day
- •History of acute infection or chronic sinusitis in the Schneiderian membrane
- •Having allergies involving the respiratory system
- •Any contraindication for systematic periodontal surgery (Patients with bleeding platelet disorders, bisphosphonate therapy, uncontrolled diabetes (HbA1c > 6%, blood glucose level > 110 mg/dl)),
- •Bilateral posterior maxilla residual bone height >5 mm
结局指标
主要结局
Histomorphometric bone changes
时间窗: Postoperatively 6th month
Following at 6th month from sinus augmentation, histological samples will be evaluated new bone formation.
Bone gain change radiologically
时间窗: Postoperatively 6th month
Change of the distance from the top of the alveolar crest to the floor of the maxillary sinus in the cone beam computerized tomography at between baseline and postoperatively 6th month.
次要结局
- Bone density changes(Postoperatively 6th month)
- Secondary Implant Stabilization(At healing cap session, following dental implant placement 3rd month)
- Primary Stabilization Value(Immediately after dental implant placement,)
研究者
Berceste Guler
Assoc. Prof.
Kutahya Health Sciences University