Free Gingival Grafts for Implants Exhibiting Lack of Keratinized Gingiva: a Prospective Controlled Randomized Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Changes in the width of Keratinized Gingiva from baseline to 6, 12, 18 months
研究概览
简要总结
This prospective controlled randomized blind clinical study investigated 44 implants displaying lack of KG in 29 subjects. Fourteen subjects received FGGs followed by oral prophylaxis. Fifteen subjects in the control group did not receive FGGs. The width of KG, gingival recession (GR), pocket depths (PD), plaque index (PI) and gingival index (GI) were assessed at baseline, 6, 12, and 18 months. Changes in crestal bone levels, from baseline, were assessed at 18 months.
详细描述
The purpose of this study was to evaluate clinical and radiographic outcomes following free gingival grafts (FGGs) around implants with limited keratinized gingiva (KG) compared to oral prophylaxis without gingival augmentation.
This prospective controlled randomized blind clinical study investigated 44 implants displaying lack of KG in 29 subjects. Fourteen subjects received FGGs followed by oral prophylaxis. Fifteen subjects in the control group did not receive FGGs. The width of KG, gingival recession (GR), pocket depths (PD), plaque index (PI) and gingival index (GI) were assessed at baseline, 6, 12, and 18 months.
There was a significant gain in KG with a reduction in GR in the FGG group compared to controls at 6, 12, and 18 months. The mean PI and GI were significantly lower for the FGG group at 12 and 18 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •less than 2 mm KG present on the facial side of implant
- •implant restoration is single unsplinted unit, and has been in function for at least 6 months with an opposing dentition.
排除标准
- •uncontrolled hypertension
- •diabetes mellitus (DM),
- •subjects with a history of a long-term (>6 months) use of corticosteroid
- •subjects currently taking bisphosphonates, or with a history of taking bisphosphonates regardless of route of administration
- •subjects on medications that cause gingival hyperplasia
- •pregnant women.
研究组 & 干预措施
Control
Oral prophylaxis
干预措施: Oral prophylaxis (Procedure)
Experimental
Free gingival grafts
干预措施: Free gingival graft (Procedure)
结局指标
主要结局
Changes in the width of Keratinized Gingiva from baseline to 6, 12, 18 months
时间窗: 6, 12, 18 months
次要结局
未报告次要终点
研究者
Se-Lim Oh
Assistant Professor
University of Maryland, Baltimore