The Study on the Healing of Soft Tissue Augmentation by the Acellular Dermal Matrix and Autogenous Subepithelial Connective Tissue Graft
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- The histological analysis of the gingival biopsy tissue.
研究概览
简要总结
The study team proposes to prospectively compare the healing outcomes of autogenous soft tissue connective tissue graft (CTG) and Acellular dermis matrix (ADM) in a split-mouth design study for patients requiring modification of gingival soft tissue biotype. The researchers aim to investigate the earlier phase of graft healing after the grafting surgery by biopsy histology and by examining the alteration of gene profile during the healing of gingival tissue healing by molecular cell biological techniques.
详细描述
The investigators will perform a prospective clinical randomized controlled trial, and recruit 12 patients who need gingival soft tissue augmentation. It is a split-mouth design: CTG will be used in one side of soft tissue augmentation, and ADM will be used on the other side. 3 months after graft healing, clinical measurements including soft tissue thickness, transparency visualization, tissue profile record with impression cast study model, and digital photography of tissue will be performed. The gingival punch biopsies ( 2mm diameters) will be performed in both sides of grafting areas under the local oral anesthesia injection. The collected tissue will be split into two halves, one for histological examination, and another half for gene analysis.
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 (Investigator)
盲法说明
The biopsy sites will be coded alphanumerically. The investigator performing the gingival grafts will be different from the examiner performing the gingival biopsies. The examiner performing the gingival biopsies will be blinded to the grafting type source of the biopsy sites.The results from coded samples will be reported to the PI, who will summarize the data.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •general healthy
- •periodontal healthy (no PD >3mm, no BOP, no mobility at the test site and control site)
- •patients identified need gingival biotype modification (need for increased tissue thickness) during the periodontal exam or referred from orthodontics
排除标准
- •current smoker or smoking history
- •taking Antibiotics or medicines within the last 3 months
- •past history of gingival soft tissue augmentation/modification surgery
结局指标
主要结局
The histological analysis of the gingival biopsy tissue.
时间窗: Month 3---after the gingival biopsy procedures
Histological analysis with standard coloration will assess the epithelium and underneath connective tissue within the gingival biopsy tissue. Signs of inflammation (ulcerations, infiltration of neutrophil cells, vessel structure) will be noted.
次要结局
- The immunohistological analysis of the gingival biopsy.(Month 3---after the gingival biopsy procedures)
- RT-qPCR analysis of gingival biopsy.(Month 3---after the gingival biopsy procedures)