Comparison of Two Different Surgical Approaches to Increase Peri-Implant Mucosa Thickness: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in Buccal Peri-implant Mucosa Thickness Between Baseline and 16 Weeks After Surgery
研究概览
简要总结
The purpose of this non-inferiority trial is to determine the clinical efficacy of acellular dermal matrix (ADM) in the augmentation of the gum around dental implants as compared to an autologous gum graft (sCTG) obtained from the palate (roof of the mouth) in human adults.
AlloDerm is regulated by the US Food and Drug Administration (FDA) as human tissue for transplantation. AlloDerm is processed and marketed in accordance with the FDA's requirements for banked human tissue (21 CFR, Part 1270 and Part 1271) and Standards for Tissue Banking of the American Association of Tissue Banks (AATB).
Twenty adult subjects will be recruited who are in need of dental implant placement with simultaneous gum grafting to increase the thickness of the facial mucosa. Half of the subjects will be randomized to the ADM group and half will be randomized to the sCTG group. The surgical intervention will be performed according to the protocol and subjects will return for follow-up 2, 4, 8, and 16 weeks post-surgery for follow-up measurements of healing, gum thickness, subject perception of pain, and esthetic photographs.
详细描述
Although little is known about the influence of peri-implant mucosa thickness (PMT) on long-term biologic outcomes, soft tissue thickness is a critical component to esthetic dental implant restorations. While the subepithelial connective tissue graft (sCTG) has been recognized as the gold standard for gingival augmentation, several studies have reported acellular dermal matrix (ADM) may produce similar outcomes. Healthy patients with a thin biotype were selected on the basis of an eligibility criteria and randomized to the control (sCTG) or test (ADM) group. Measurements were completed by a masked examiner at baseline and at implant uncovering. Patient reported outcomes were recorded, as well. A power analysis suggested 20 subjects be recruited. The gain in PMT at 1mm, 3mm and 5mm from the expected CEJ and recipient site wound dehiscence were measured and recorded in both groups at different time points by a calibrated, masked examiner. Patient-related outcome measures (PROMs), such as pain and level of satisfaction with final outcome, were also recorded for all study participants.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Control
Autologous subepithelial connective tissue graft
干预措施: Autologous subepithelial connective tissue graft (Procedure)
Experimental
Acellular Dermal Matrix
干预措施: Acellular Dermal Matrix (Drug)
结局指标
主要结局
Change in Buccal Peri-implant Mucosa Thickness Between Baseline and 16 Weeks After Surgery
时间窗: Baseline and 16 weeks after baseline
Buccal mucosa thickness measurements were obtained by a calibrated, masked examiner using a custom-made stent and an endo file for precision and reproducibility between different time points
次要结局
- Patient-perceived Discomfort, Measured by VAS(2 weeks)
- Wound Healing, Measured Using a Standardized Visual Wound Healing Index(2 weeks)
- Changes in Peri-implant Keratinized Mucosa Width (Apico-coronal) at 16 Weeks After Surgery(Baseline to 16 weeks after baseline)
研究者
Gustavo Avila-Ortiz
Associate Professor
University of Iowa