Histomorphometric and Cone Beam Computed Tomography Assessments on the Influence a Collagen Membrane Placed Subjacent the Sinus Mucosa 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
- New bone-to-implant contact
研究概览
简要总结
the purpose of the study is to look for differences in dimensional variations of augmented maxillary sinuses with or without the placement of a collagen membrane subjacent the sinus mucosa.
详细描述
Material and Methods
After the elevation of the maxillary sinus mucosa, a collagen membrane with standard dimensions will be placed at the test sites subjacent the sinus mucosa and the elevated space will be filled with a xenograft, both test and control groups. A collagen membrane will be placed to cover the antrostomy at both groups and sutures will be provided to close the wound. After six months of healing, mini-implants will be installed. After 9 months, biopsies containing the mini-implants will be harvested for histomorphometric analyses. 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). Osseointegration of the mini-implants and dimensional changes over time of soft and hard tissues will be evaluated on the CBCTs.
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 (Care Provider, Investigator)
盲法说明
An author not involved in the surgeries will perform the randomization process. The assignments will be sealed within opaque envelopes that will be opened after the completion of the elevation of the sinus mucosa.
入排标准
- 年龄范围
- 21 Years 至 —（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
- •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
New bone-to-implant contact
时间窗: Mini-implants will be installed six months after sinus lifting and retrieved after three months of healing.
Measurements will be assessed between the most coronal (B) and the most apical (A) contacts of new bone to the implant surface.
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.
Measurements will be assessed in the medial, middle and lateral regions of the elevated zone using the cone beam computerized tomographies (CBCTs) taken in various periods.
次要结局
- Changing in mucosa thickness(The CBCTs will be taken before surgery (T0) and 1-week (T1) and 9 months (T2) after surgery.)
- New bone density around the mini-implant, from B to A and up to a distance of 400 µm from the implant surface.(Mini-implants will be installed six months after sinus lifting and retrieved after three months of healing)