NCT03713073已完成不适用
Clinical and Histological Outcomes of Allogenic Amnion Chorion Membrane in the Healing of Free Gingival Graft Donor Site
The University of Texas Health Science Center, Houston2 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2016年10月3日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Size of Wound Area
研究概览
简要总结
The purpose of this study is to compare an allogenic amnion chorion membrane to a collagen dressing in palatal wound healing after harvesting free gingival graft (FGG).
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients attending the Clinic for Graduate Periodontics at The University of Texas health Science Center at Houston School of Dentistry who are in need of a Free Gingival Graft procedure to augment keratinized gingiva, augment ridge, or cover recession defects.
- •systemically healthy or with controlled common systemic conditions, such as hypertension, that will not affect wound healing.
排除标准
- •size of the FGG that the patient needs bigger than the size of FGGs that have to be harvested in this study (two 8mm (width) x 10mm (length) x ≈1.5mm (thickness) FGG).
- •current heavy smokers(>10 cigarettes/day) (patients who stop smoking more than one year are eligible)
- •have diabetes or other systemic diseases that may comprise healing
- •take antibiotics and/or analgesics within one week before the procedure and have loss of sensation on the palate
结局指标
主要结局
Size of Wound Area
时间窗: 60 days
The wound area will be assessed by means of a clinical picture. The picture will be taken with an angulation perpendicular to the wound. A periodontal probe will be placed by the wound as a reference scale. Wound area is defined as the area without epithelization. The wound area on the picture will be measured by ImageJ.
次要结局
- Number of Neutrophil Cells as Assessed by Light Microscopy of Haematoxylin and Eosin (H&E)-Stained Biopsy Sections(10 days)
- Pain as Assessed by a Visual Analogue Scale (VAS)(60 days)
- Number of Participants Stratified as Per the Degree of Epithelialization of Wound(60 days)
- Clinician's Feedback on the Wound Dressing Material as Assessed by a Questionnaire(at the time of placement of the wound dressing material)
- Change in Percentage of Collagen Density in Wound Area as Assessed by Light Microscopy of Masson's Trichrome-stained Biopsy Sections(baseline, 10 days)
- Number of Participants With Haemostasis of Wound Area(60 days)
- Relative Difference in Color of Wound Site Compared to Adjacent Gingiva(60 days)
- Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS)(60 days)
- Volume of Wound(60 days)
- Thickness of the Epithelium as Assessed by Light Microscopy of Haematoxylin and Eosin (H&E)-Stained Biopsy Sections(10 days)
- Angiogenesis as Indicated by Number of Blood Vessels as Assessed by Light Microscopy of Biopsy Sections Immunohistochemically Stained to Detect Factor VIII (Von Willebrandt Factor)(10 days)
研究者
Chun-Teh Lee
Assistant Professor
The University of Texas Health Science Center, Houston
研究点 (2)
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