Extraction and Socket Preservation Before Implant Placement Using Freezed Dried Allograft (FDBA) and Platelet-Rich Fibrin in Smokers. A Single Blinded Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- bone height after ridge preservation.
研究概览
简要总结
the investigators aim from this study to evaluate platelet rich fibrin potential to heal the periodontal tissue and to form new native bone in smokers that require socket augmentation following dental extraction and before implant placement.
Materials and Methods: 18 adult smoker patients with 40 extracted sockets were recruited for this study, and the extracted sockets were distributed into four different groups as follows; Group 1- A-PRF alone, Group 2- Factors-enriched bone graft matrix (commonly known as sticky bone) using autologous fibrin glue combined with an FDBA with CGF-Enriched Fibrin Membrane to covered it, Group 3- an FDBA with a crosslinked collagen membrane and Group 4-Resorbable collagen plug (RCP) alone serving as a negative control group.
The patients were randomly grouped into a previously mentioned group, and the socket dimensions were measured four times, immediately after the extraction (0 days), after 10, 21, and 28 days to assess epithelial layer healing.
After six months and before placing the implant fixture, both soft and hard tissue samples will be harvested to be evaluated and compared histologically, also standardized CBCT will be taken before and after extraction to evaluate the amount of mineral content and vital bone formation radiographically.
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
- Single (Participant)
入排标准
- 年龄范围
- 21 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Current smokers
- •have at least one tooth indicated for extraction due to extensive decay, tooth fracture or failed root canal treatment.
- •21 years of age or older.
- •give a written consent to participate in the trial.
- •have the desire to have an implant restoration for at least one non-restorable tooth
- •indicated for socket preservation procedures and generally healthy with no systematic disease
排除标准
- •subjects who unable to undergo oral surgery procedures due to a medical condition.
- •women who are pregnant or nursing a child.
- •subjects with dental infection of bone, active periodontal disease and ankylosed teeth.
- •Subjects with following systemic diseases and conditions: Chemotherapy or radiation for the treatment of cancer and arthritis, seriously impaired cardiovascular or pulmonary function, uncontrolled diabetes, auto-immune compromised diseases, kidney or liver disease and history of severe, multiple allergies.
结局指标
主要结局
bone height after ridge preservation.
时间窗: 6 months
two different measurements shall be taken at baseline and after 6 months using Cone-beam computed tomography to asess vertical resorption measured by mean difference in length of socket.
soft tissue healing and migration.
时间窗: 28 days
In all groups, the buccolingual and mesiodistal dimensions at the osseous crest of the extraction socket will be measured at the midpoints immediately after extraction with a University of Michigan O Probe with Williams marking (Hu-Friedy® Mfg Chicago, IL, USA) at 0, 10, 21, and 28 days.
bone width after ridge preservation.
时间窗: 6 months
two different measurements shall be taken at baseline and after 6 months using Cone-beam computed tomography to asess the mean width ridge difference between outer border of buccal and lingual cortical plate at Socket depth at 1, 3,5 mm.
次要结局
未报告次要终点
研究者
yasser fahad alrayyes
Doctor, PHD student
King Saud University