Blood Flow Analysis of the Human Mucosa After Vestibuloplasty Procedures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Postoperative blood flow changes of the oral mucosa
研究概览
简要总结
Apply the LSCI for follow-up the postoperative microcirculation after surgical procedures to enlarge keratinized gingiva in order to characterize the kinetics of the blood flow changes during wound healing in human subjects.
详细描述
Vestibuloplasty is the common name of those procedures designed to widen the zone of attached gingiva. The apically repositioned split thickness flap with a xenogeneic collagen matrix or with a combination of strip gingival graft and a xenogeneic collagen matrix are frequently used surgical techniques, however no data are available, how these graft tissues affect the microcirculation of the healing gingiva.
LSCI is a non-invasive, two dimensional method to evaluate microcirculation of different tissues. This new method let us monitor the entire surgical area real-time during the healing period.
The aim of the present study is to define blood flow patterns, which might characterize the wound healing of such surgical procedures during the first 6 months of healing in order to facilitate treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •clinical diagnosis of inadequate width of keratinized gingiva at the mandibular front region
排除标准
- •pregnancy
- •heavy smoking
- •general diseases
- •taking medications or having treatments which have an effect on mucosal healing in general (e.g. steroids, anti-inflammatory drugs)
- •taking any other medications in the last three months (except contraceptives)
结局指标
主要结局
Postoperative blood flow changes of the oral mucosa
时间窗: 6 months after surgery
Blood flow changes are measured by Laser Speckle Contrast Imager (LSCI) after mandibular vestibuloplasty. The scale is an arbitrary unit (0-3000 LSPU) and the relative changes to the surgically unaffected surrounding mucosa measurements are calculated. Postoperative follow-up time-points are: 1, 2, 3, 4, 5, 6, 7, 9, 11, 14, 21, 28 days, and 2, 3, 4, 5, 6 months. The apically repositioned split thickness flap is combined either with a Mucograft alone, or with a combination of autologous strip gingival graft and Mucograft. The differences in postoperative blood flow changes are compared between the two surgical techniques.
次要结局
- Wound fluid volume measurement(14 days after surgery)
- Evaluation of the periodontal parameters at teeth at the surgical site: a composite outcome measure consisting of multiple measures.(Pre- and six month postoperative)
- Quantitative determination of Vascular Endothelial Growth Factor (VEGF) of the wound fluid(4 days after surgery)
研究者
Dr. Vag Janos
associate professor
Semmelweis University