Evaluation of the Three-dimensional Changes in Free Gingival Grafts Around Dental Implants
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- The three-dimensional changes of free gingival graft
研究概览
简要总结
The purpose of this study is to evaluate the stability of the free gingival graft dimensions around dental implants and to compare three-dimensional changes according to smoking status. Its primary goal is to provide an answer to:
Is this grafting procedure stable around dental implants? Are there any differences in tissue stability between smoker and non-smoker patients?
Our study consists of 2 groups:
The first group includes smoker patients who need free gingival grafts around their dental implants (n=16).
The second group includes non-smoker patients who need free gingival grafts around their dental implants (n=16).
Clinical measurements will be recorded at the baseline, 1st month, 3rd month, and 6th month of the study. An intraoral digital scanner will be used to measure the dimension changes of the graft at the baseline, after the surgery, 1st month, 3rd month, and 6th month of the study. Wound healing will be evaluated on postoperative days 10, 1 month, 3 months, and 6 months. Visual Analog Scale will be used to measure postoperative pain, and the number of painkillers taken will be recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- 是
入选标准
- •Periodontal and peri-implant tissue health
- •Good oral hygiene (plaque accumulation <20%)
- •Either around the functioning implant or in patients scheduled for second-stage surgery following implant surgery <2 mm keratinized gingiva on the vestibular side of the implant
- •No systemic disease and medication use that may affect soft tissue healing.
- •Volunteering to participate in the study
排除标准
- •Systemic disease that is a contraindication to the surgical procedure,
- •Uncontrolled diabetes (HbA1c > 7),
- •Being pregnant or breastfeeding,
- •Autoimmune and/or inflammatory diseases of the oral cavity,
- •Active periodontal disease,
- •Incorrectly positioned implants
结局指标
主要结局
The three-dimensional changes of free gingival graft
时间窗: 6th month
An intraoral digital scanner will be used to assess the graft's dimensions alterations.
The three-dimensional changes of free gingival graft.
时间窗: 1st month
An intraoral digital scanner will be used to assess the graft's dimensions alterations.
次要结局
- Bleeding on probing(6th month)
- Keratinized mucosa width(6th month)
- Wound healing(6th month)
- Gingival Index(6th month)
- Probing depth(6th month)
- Patient reported outcomes(10th day)
- Plaque index(6th month)
研究者
Ayse Ege SELMAN
Principle Investigator
Biruni University