Alveolar Ridge Augmentation Using Resorbable Bioactive Silica-calcium Phosphate Composite (SCPC): Clinical and Histology Evaluation
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Histological outcome
研究概览
简要总结
Ideal bone graft should possess osteogenic, osteoinductive, and osteoconductive properties. Unfortunately, all of these are solely found within the autogenous graft that is available only in limited quantities, and it is associated with substantial post-surgical morbidity, However in this study Silica-calcium phosphate composite (SCPC) confirmed clinically, radiographically, histomorphometricand immunohistochemically the vitality and functionality of the newly formed bone. Histology and immunohistochemistry demonstrated maturation of the newly formed bone as indicated by presence of osteocytes, Haversian systems, blood vessels, compact mineralized collagen type I and high immune staining for osteopontin.
详细描述
Alveolar ridge resorption following teeth extraction leads to 50% loss in bone width over one year period which corresponds to 5 -7 mm mainly from the buccal rather than palatal\lingual aspects. Several calcium phosphates from bovine and synthetics sources are used for preservation of extraction socket; however with variable degrees of success. The aim of the present study is to evaluate clinically, radiographically and histologically the effect of Silica-calcium phosphate composite (SCPC) granules on new bone formation qualitatively and quantitatively following socket augmentation. This case series study was performed in five (n = 5) participants (one male and four females), all participants underwent socket augmentation procedures and dental implant placement in a staged approach. All participants were fully informed about the procedures, including the surgery, bone substitute materials and implants. Each participant had one extraction socket to be grafted with silica-calcium phosphate SCPC dental bone graft granules and the contralateral socket served as ungrafted control. Clinical, radiographic and histological evaluation was assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients require extraction of bilateral non-restorable (premolar or anterior) tooth located in the maxillary arch and need implant restoration.
- •Teeth to be extracted are free from acute periapical infection or active periodontitis.
- •Buccal plate of bone is intact
- •Systemic free patients
- •Patients were able to swallow tablets.
排除标准
- •Patients with remaining root accompanied with acute periapical infection or sinus tract
- •Insulin dependent diabetes patients.
- •Thyroid disease patients.
- •Smoker´s patients
- •Patients with compromised health (ASA (III or IV) - according to the classification of American Society of Anaesthesiology including drug or alcohol abuse or any significant systemic disease.
研究组 & 干预措施
Silica-calcium phosphate composite Group
Participants underwent socket augmentation procedures and dental implant placement in a staged approach. Atraumatic extraction of badly decayed tooth was performed. The socket was debrided with curettes and alveolar spoons; the granulation tissue was carefully removed. Free gingival gingival graft (1.5 to 2 mm thick) was taken from the area between the first and second premolar, 5 mm from gingival margin. Bioactive porous SCPC dental bone graft granules in the size range 90-710 micron were mixed with saline and loosely packed in the extraction sockets as per the manufacturer. The grafted SCPC granules were covered with free gingival graft obtained from the palatal tissues and sutured to stabilize the grafting material in place.
干预措施: Socket Graft (Device)
Control Group
Participants underwent atraumatic extraction of badly decayed tooth was performed. The socket was debrided with curettes and alveolar spoons; the granulation tissue was carefully removed. The socket left to heal.
干预措施: Socket Graft (Device)
结局指标
主要结局
Histological outcome
时间窗: 7 months
histomorphometric measurement of amount of residual graft percent and amount of new vital bone formation in the newly formed bone. The sections were obtained from the core biopsy in 5µm thickness and were stained by Hematoxylin and Eosin.
Clinical outcome
时间窗: 5 months
Clinical parameters on the tooth to be extracted in both test and control groups were assessed. Buccal gingival thickness was measured using clinical reference points 4 mm away from the gingival margin by a graduated periodontal probe.
次要结局
- Immunohistochemical analysis(7 months)
研究者
Doaa Adel
Lecturer of Periodontology, Faculty of Dentistry
Ain Shams University