Cone Beam Computed Tomography and Histomorphometric Assessments on the Influence a Collagen Membrane Placed on the Antrostomy After Maxillary Sinus Floor Augmentation. A Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Changing in height of the elevated zone.
研究概览
简要总结
the aim of the present study was to evaluate the dimensional variation and osseointegration of mini-implants at augmented sinus with the antrostomy left unprotected or protected with a collagen membrane.
详细描述
The Schneiderian mucosa will be elevated and the created space will be filled with a natural bovine bone grafting material (Cerabone® 1-2 mm, Botiss Biomaterials GmbH). In ten patients randomly selected (control sties), a native collagen membrane made of porcine dermis (Collprotect®, Botiss Biomaterials GmbH) will be placed on the antrostomy. In another ten patients of the test group, the antrostomy will be left without the membrane. The flaps will be sutured and anti-inflammatory drugs and antibiotics will be administrated to the patients. The sutures will be removed after 7 days. After 6 months of healing, two mini-implants with different surface will be installed and retrieved after further 3 months for histomorphometric evaluations.
CBCTs will be taken for all patients before surgery (T0), after 1 week from sinus floor augmentation (T1) and after 9 months of healing (T2) and evaluation of dimensional variations over time of soft and hard tissues will be performed.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
the surgeon will be blinded until the maxillary sinus augmentation is filled with the biomaterial.
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Presence of an edentulous atrophic zone in the posterior segment of the maxilla
- •Height of the sinus floor ≤4 mm.
- •Desiring a prosthetic restoration of the zone using a fix prosthesis supported by implants
- •≥ 21 years of age
- •Good general health
- •No contraindication for oral surgical procedures
- •Not being pregnant.
排除标准
- •The patients will be excluded if they present:
- •A systemic disordered.
- •Had a chemotherapic or radiotherapeutic treatment.
- •Are smokers >10 cigarettes per day
- •Have an acute or a chronic sinusitis.
- •Had a previous bone augmentation procedures in the zone of interest.
结局指标
主要结局
Changing in height of the elevated zone.
时间窗: The CBCTs will be taken before surgery (T0) and 1-week (T1) and 9 months (T2) after surgery
will be assessed in the medial, middle and lateral regions of the elevated zone using the cone beam computerized tomographies
Bone-to-implant contact between the different surfaces and between membrane / no membrane groups
时间窗: three months of healing
Measurements of new bone formation will be assessed on the histological images taken from the slides and performed between the most coronal bone contact to the surface and the apex of the mini-implant. Comparisons among test and control (without or with a collagen membrane of the access window) and between the two different surface conformations will be performed
次要结局
- Changing in area of the elevated zone(The CBCTs will be taken before surgery (T0) and 1-week (T1) and 9 months (T2) after surgery)
- Bone density(three months of healing)