Expression of Angiogenic Biomarkers During Healing of Intra-Oral Soft Tissue Engineered Grafts
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Differences in Angiogenic Biomarkers
研究概览
简要总结
The purpose of this observational research study is to understand more about wound healing of gum tissue. This study was the biomarker study of a small cohort of study participants derived from NCT01547962 (completed). Two surgical sites of each patient were randomly selected to receive CelTx™ as a donor material in one site and conventional autograft using keratinized tissue from the palate as the donor material at the contralateral (opposite side) site. Fluids collected from between a tooth and the gum and directly from wounds contain proteins that occur in different levels as the wound healing process proceeds. In this research study wound fluid will be collected from the donor palate site (roof of your mouth) and the treated sites on your gum before and after placement of CelTx and conventional treatment (tissue from the roof of your mouth) to measure which proteins and how much of each are present during the first 4 weeks of wound healing.
详细描述
In a clinical trial designed to evaluate the safety and effectiveness of rhPDGF-BB to promote soft and hard tissue engineering of the periodontium, the subjects provided gingival crevicular fluid (GCF) or periodontal wound fluid (WF) and the results demonstrated contrasting inducible expression patterns of PDGF-AB, VEGF, and ICTP during periodontal healing [17, 24, 25]. However, little is known regarding the release of these molecules into local periodontal wound fluid during tissue-engineered grafts.
The aim of this study is to determine the presence and influence of angiogenic biomarkers, such as PDGF, VEGF, and FGF, involved in the wound healing process of tissue engineered grafts in the treatment of subjects (with recession-type defects) who have an insufficient zone of attached gingival associated with at least two nonadjacent teeth.
STUDY OBJECTIVES The purpose of this pilot study is to compare the expression of angiogenic biomarkers involved in the wound healing process of 2 different periodontal surgical approaches: 1) CelTx™ (living bilayered cell therapy product) and 2) free gingival grafts
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
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
- •Subject has signed informed consent to participate in Organogenesis Clinical Protocol 06-PER-002-CTX.
- •Subject has signed informed consent to participate in this adjunct bio-marker study.
- •Subject is willing to comply with the additional study visits at weeks 2 and 3 as required by this study.
排除标准
- •Subject requires antibiotic prophylaxis for routine dental procedures.
结局指标
主要结局
Differences in Angiogenic Biomarkers
时间窗: 5 time-points: pre-surgical, week(s) 1, 2, 3 and 4
Within-subject difference between the concentrations at the CelTX and Free Gingival Graft areas
Differences in Angiogenic Biomarkers: PDGF-BB
时间窗: 5 time-points: pre-surgical, week(s) 1, 2, 3 and 4
Within-subject difference between the concentrations at the CelTX and Free Gingival Graft areas
次要结局
未报告次要终点
研究者
William Giannobile
Chair, Department of Periodontics & Oral Medicine Najjar Endowed Professor of Dentistry and Biomedical Engineering
University of Michigan