Tunnel Technique With Emdogain® in Addition to Connective Tissue Graft Compared With Connective Tissue Graft Alone for the Treatment of Gingival (Periodontal?) Recessions: a Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Clinical attachment level (CAL)
研究概览
简要总结
Microsurgical tunneling flap procedures using connective tissue grafts (CTG) are predictable for treating teeth with gingival recessions. Enamel matrix derivatives (EMD) can be used as an alternative to the aforementioned gold standard. The aim of this study is to evaluate clinically the use of tunnel technique with EMD applied group in addition to CTG and the same technique with CTG group for the treatment of multiple gingival recessions.
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 (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Bilateral multiple gingival recessions in homologous teeth
排除标准
- •Full-mouth plaque index ≥ 20% (Ainamo & Bay 1975)
- •Full-mouth sulcus bleeding index ≥ 15% (Mühlemann & Son 1971)
- •Systemic diseases with compromised healing potential of infectious diseases
- •Drugs affecting periodontal health / healing
- •Pregnant and lactating females
- •Previous periodontal surgery in the area
研究组 & 干预措施
Recession coverage with connective tissue graft + Emdogain®
A modified microsurgical tunnel technique by Zuhr et al. (2007). Initial sulcular incisions with a microsurgical blade are followed by a split-thickness buccal flap preparations using the tunneling knives. The preparation is extended into the mucosal tissue to gain sufficient flap mobility. The papillary regions are detached in their buccal aspects with the periosteum. The root surfaces are applied with 24% EDTA (PrefGel®, Straumann, Basel, Switzerland) for 2 minutes and then washed with saline. Subsequently, EMD (Emdogain®, Straumann, Basel, Switzerland) is applied on root surfaces. The graft is inserted into the tunnel and stabilized with absorbable suspensory sutures. The buccal flap is advanced coronally and stabilized with non-absorbable suspensory sutures.
干预措施: The tunnel technique for root coverage with Emdogain (Device)
Recession coverage with connective tissue graft
Procedure: A modified microsurgical tunnel technique by Zuhr et al. (2007). Initial sulcular incisions with a microsurgical blade are followed by a split-thickness buccal flap preparations using the tunneling knives. The preparation is extended into the mucosal tissue to gain sufficient flap mobility. The papillary regions are detached in their buccal aspects with the periosteum. The graft is inserted into the tunnel and stabilized with absorbable suspensory sutures. The buccal flap is advanced coronally and stabilized with non-absorbable suspensory sutures.
干预措施: The tunnel technique for root coverage without Emdogain (Device)
结局指标
主要结局
Clinical attachment level (CAL)
时间窗: 6 months after surgery
Distance from the cementoenamel junction to the bottom of the gingival sulcus
次要结局
- Recession height (RH)(6 months after surgery)
- Recession width (RW)(6 months after surgery)
- Width of keratinized tissue (WKT)(6 months after surgery)
- Thickness of keratinized tissue (TKT)(6 months after surgery)
- Average recession coverage (ARC)(6 months after surgery)
- Complete recession coverage(6 months after surgery)