Proof of Concept: Intra-oral Soft Tissue Preservation of Extraction Sockets in Anterior Upper Jaw
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Soft tissue volume
研究概览
简要总结
It is planned to evaluate if a porcine collagen matrix (Mucograft Seal) is offering comparable results to free gingival grafts (FGG) in post-extraction tissue preservation. If so, this would provide a substantial benefit to the patient as the second intervention on the palate and the subsequent morbidity of the donor site is omitted.
详细描述
In a proof of concept 5 groups are compared in preserving soft- and hard tissue after tooth extraction in the esthetic zone:
- Mucograft® Seal + Bio-Oss®
- Free Gingival Graft (FGG) + Bio-Oss®
- Free Gingival Graft + Gelatine sponge (Spongostan®)
- Spongostan®+ Mucograft® Seal
- Spongostan®
Volumetric changes of hard and soft tissues are recorded , 2/4/8 weeks and 3/6/12 months after extraction.
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
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Planned extraction in the upper front or premolar region
排除标准
- •General risk situation (antiresorptive therapy, antiangiogenic therapy, history of local radiation therapy, heavy coagulation disorder, relevant allergies, dysregulated Diabetes mellitus, malignant diseases)
- •Acute gingivitis
- •Deep pockets (>5.5mm)
- •Apical periodontitis on neighboring teeth
- •Heavy smoker (>10/d)
研究组 & 干预措施
5. Spongostan®
1. Mucograft® Seal + Bio-Oss®
干预措施: BioOss® + Mucograft Seal® (Device)
2. FGG + Bio-Oss®
干预措施: FGG + Bio-Oss® (Other)
3. FGG + Gelatine sponge (Spongostan®)
干预措施: FGG + Gelatine sponge (Spongostan®) (Other)
4. Spongostan®+ Mucograft® Seal
干预措施: Spongostan®+ Mucograft® Seal (Device)
结局指标
主要结局
Soft tissue volume
时间窗: 8 weeks
次要结局
- Bone volume(12 months)