The "One-piece" Autologous Tuberosity Graft : a Novel Concept in Ridge Preservation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Change of Horizontal dimension of the ridge from baseline to 4 months post-op
研究概览
简要总结
A prospective study investigating clinically and radiologically the effectiveness of the use of a combined hard and soft tissue graft retrieved from the maxillary tuberosity and designed for alveolar ridge preservation following tooth extraction.
详细描述
Patients scheduled for a single mono-rooted tooth extraction are included in the study. After atraumatic extraction, sockets are filled with a "one-piece" dual tissue graft harvested from the tuberosity using an adjusted trephine. CBCTs are performed before the extraction and 4 months after ridge preservation, to analyze the vertical and horizontal alterations of the ridge, using 'ITK-Snap' software.
Clinical measurements of both soft and hard tissues are also assessed during the extraction and implant placement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Healthy patient
- •Patient with at least one single-rooted tooth to be extracted and be replaced with an implant
- •No signs of acute infection : edema, suppuration, abscess, spontaneous bleeding
- •Non-smoker or Light Smoker < 10 cigarettes/day
排除标准
- •Pregnant or lactating females
- •Non-controlled periodontal disease
- •Medical conditions that contraindicate implant surgery
- •Metabolic bone disorders such as osteoporosis,..
- •Severe psychiatric conditions
- •Heavy smoker > 10 cigarettes/day
研究组 & 干预措施
Socket preservation group
Extraction sockets filled with a "one-piece" dual tissue graft harvested from the tuberosity using an adjusted trephine.
干预措施: Socket preservation (Procedure)
结局指标
主要结局
Change of Horizontal dimension of the ridge from baseline to 4 months post-op
时间窗: 4 months
Linear Horizontal variation of the ridge at 3 different levels, measured on superimposed images of CBCT.
Change of volume of the ridge from baseline to 4 months post-op
时间窗: 4 months
Volumetric variation of the ridge, measured on superimposed images of CBCT.
Change of Vertical dimension of the ridge from baseline to 4 months post-op
时间窗: 4 months
Linear Vertical variation of the ridge, measured on superimposed images of CBCT.
Change in Soft tissue from baseline to 4 months post-op
时间窗: 4 months
Variation of the thickness of the buccal keratinized mucosa at 2 different levels, measured on superimposed images of CBCT.
次要结局
- Change in crestal Soft tissue from baseline to 4 months post-op (clinical measurements)(4 months)
- Change in buccal Soft tissue from baseline to 4 months post-op (clinical measurements)(4 months)
- Change in Hard tissue from baseline to 4 months post-op (clinical measurements)(4 months)