Ridge Preservation With the Use of a Xenogenic Bone Graft Material (Symbios Xenograft Granules) and a Pre-hydrated Collagen Membrane Symbios Pre-hydrated Collagen Resorbable Membrane): A Pilot Multicenter Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 45
- 试验地点
- 10
- 主要终点
- Composition of new-formed hard tissue into the post-extractive socket
研究概览
简要总结
This pilot multicentric randomized controlled clinical trial is aimed at evaluating the composition of the new-formed tissue into the dental socket after 6 months from tooth extraction and the application of a combination of xenograft bone granules and collagen membrane. Extraction sites will be either grafted with Dentsply Symbios Xenograft Granules and covered with Dentsply Symbios pre-hydrated Collagen Resorbable Membrane or grafted with Geistlich Bio-Oss Collagen and covered with Geistlich Bio-Gide membrane. Results will be compared to spontaneous socket healing.
详细描述
Rational
Socket preservation techniques are effective in mitigating the dimensional changes of the alveolar socket that spontaneously occur after tooth extraction (Avila-Ortiz G, et al. 2019). However, there is insufficient information regarding the type and quality of the newly formed tissue at the extraction site before implant positioning.
Study design
This study is a three-arm multicentric randomized trial that will evaluate the bone healing following ridge preservation of extraction sockets using two different combinations of commercially available xenograft bone granules and collagen membranes available in the market. Results will be compared to tissues obtained from spontaneous healing. A total of 45 participants (15 in each arm) is expected.
Study protocol
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •have at least one tooth (from the central incisor to the second permanent molar) to be extracted and replaced with an endosseous implant;
- •no need of a temporary prosthesis;
- •availability to participate to the follow-up;
- •sign the study informed consent and consent to data treatment;
排除标准
- •less than 20 years;
- •known allergy to collagen or bone graft material;
- •contraindications to implant therapy;
- •ongoing bisphosphonate-based therapy;
- •ongoing high-dose corticosteroid therapy;
- •relevant co-morbidities of the maxillary bones that interfere with bone remodeling (degenerative bone diseases, osteomyelitis at the extraction site or surrounding areas, subacute mandibular osteitis, local microvascular disorders);
- •pregnancy;
- •metabolic diseases (diabetes, hyperparathyroidism);
- •systemic bone diseases;
结局指标
主要结局
Composition of new-formed hard tissue into the post-extractive socket
时间窗: Six months after surgery
Amount of mineralized bone, residual biomaterial, fibrous tissue
Composition of new-formed soft tissue over the post-extractive socket
时间窗: Six months after surgery
Amount of epithelial tissue, connective tissue, of neovascularization, inflammatory cells, residual collagenic biomaterial
次要结局
- Implant torque at insertion(Six months after surgery, at implant insertion.)
- Width of keratinized mucosa(Six months after surgery, at implant insertion.)