Treatment of Local Gingival Recession With an Enamel Matrix Protein Coated Collagen Matrix - a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 主要终点
- Gingival recession height
研究概览
简要总结
The clinical trial studies patients with gingival recession defects (receding gums).
The goal of the study is to test whether the additional use of enamel matrix derivatives (EMD), combined with the use of a coronally advance flap (CAF) and a CM (collagen matrix), shows a better outcome compared to a comparison group. The comparison group comprises patients receiving treatment with CAF and CM without the use of EMD.
详细描述
The study aims to evaluate the influence of the additional use of EMD in treatment of gingival recession defects using a coronally advance flap (CAF) and a CM (collagen matrix) by means of digital and clinical assessment methods. The reference group comprises patients receiving treatment with CAF and CM without the application of EMD.
In this prospective, randomized, controlled study, recession height and area, width and thickness of keratinized gingiva, pocket probing depth, and the clinical attachment level were measured at baseline and followed-up for one year.
15 patients with 24 gingival recession defects (Recession Type 1 after Cairo/Miller Class I or II) were recruited and were randomly assigned into the two treatment groups.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed Informed Consent
- •able to achieve good oral hygiene (full mouth plaque score < 20 %, full mouth bleeding score < 20%),
- •patients presenting with at least one gingival recession defect
排除标准
- •general contraindications to dental surgery under local anaesthesia (e.g., severe systemic diseases, tumours, severe cardiovascular diseases, uncontrolled diabetes mellitus);
- •ongoing or previous chemotherapy, radiotherapy, or bisphosphonate therapy;
- •self-reported heavy smokers (more than 10 cigarettes/day);
- •pregnancy and nursing mothers;
- •disorders or treatments that impair wound healing;
- •long-term treatment with high-dose steroids or anticoagulants;
- •bone metabolism disorders;
- •infections or vascular disorders in the region to be treated;
- •known hypersensitivity to porcine collagen;
- •patients with severe peripheral artery disease or autoimmune diseases;
- •extruded or malpositioned teeth.
结局指标
主要结局
Gingival recession height
时间窗: 12 months postoperatively
Gingival recession height in millimeters, measured as the distance from cementoenamel junction to gingival margin
次要结局
- pocket probing depth (PPD)(12 months postoperatively)
- Width of keratinized tissue (WKT)(12 months postoperatively)
- Clinical attachment loss (CAL)(12 months postoperatively)