Comparative Clinical Performance of Biphasic Calcium Sulfate Cement Matrix With Hydroxyapatite Granules in a Socket Preservation Model: a Pilot Clinical Trial Parallel Group Assignment
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 主要终点
- Histologic Examination Histomorphometric Analysis
研究概览
简要总结
When a dental extraction is performed, sequential cascade of events happens that lead to a modeling and remodeling of the area.
This phenomenon leads to bone resorption and consequential volume loss atrophy. In literature several biomaterials (Autogenous, alloplastic, allografts and xenografts) were tested as alveolar fillers with the aim of controlling this physiologic event.
Socket preservation is today a very widely spread dental technic to preserve the alveolar dimensions, that uses a wide range of biomaterials.
Alloplastic materials have a fair evidence to work in several regenerative procedures in the oral and maxillofacial region.
This pilot trial aims to characterize Histologic bone healing pattern in a human socket preservation model of 2/3 biphasic calcium sulfate cement matrix's and Hydroxyapatite (HA granules).
Alterations in Volumetric alveolar socket changes in a socket preservation clinical model will also be studied.
详细描述
Aim : To evaluate histologic performance and volumetric outcome of a bone substitute used in dentistry for guided bone regeneration procedures.
Model : Human Socket preservation surgery with a control group of spontaneous alveolar healing.
Inclusion criteria includes a class 2 or 3 (loss of at least 1/3 of the buccal bone of the alveolar socket) post-extraction sockets.
Clinical Experimental Methodology :
Atraumatic extraction of the hopeless tooth without flap retraction, after socket mechanical debridement , fill with 2/3 biphasic calcium sulfate cement matrix's with Hydroxyapatite (HA granules) and covered with a resorbable membrane.
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
- Single (Outcomes Assessor)
盲法说明
Person who does the volumetric analysis is blinded, Person who makes data treatment is blinded
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 18 or over
- •requiring extraction of teeth in the premolar region and anterior maxilla (15-25), presence of intact 2/3 or less, buccal bone plate
- •ASA (Physical Status Classification System, American Society of Anesthesiologist) I or II.
排除标准
- •patients with uncompensated systemic diseases, metabolic and healing disorders, i.e. diabetes mellitus, hyperparathyroidism, cancer, HIV,
- •heavy smokers (>5 cigarettes/ day),
- •bone metabolic diseases,
- •severe renal dysfunction or liver disease,
- •had received systemic corticosteroids or other immunosuppressive agents, radiation therapy and/or chemotherapy for the past 2 months,
- •active infections in the surgical site
- •patients with periodontal or/and endodontic disease
结局指标
主要结局
Histologic Examination Histomorphometric Analysis
时间窗: 3 month after tooth extraction
Histologic measure, percentage of Vital Bone formation, Fibrous/connective tissue, and material remnant present in the sample.
次要结局
- Primary and Secondary stability(at implant placement and at dental crown insertion up to 1 year)
- Incidence of Implant Success rate(at final treatment (crown insertion) up to 1 year)
- Radiographic CBCT - Bone evaluation(at pre-extraction and at final crown insertion up to 1 year)
- Implant probing depth(At implant insertion and At final treatment (crown insertion) up to 1 year)
- Implant marginal bone loss.(at implant placement and at final crown insertion (up to 1 year))
- Incidence of Survival rate(at dental crown placement (final treatment) up to 1 year)
- Volumetric Changes Clinical(at pre-extraction and at final crown insertion up to 1 year)