Aesthetic Evaluation of Free Gingival Graft Applied by Partial De-epithelialization and Free Gingival Graft Applied by Conventional Method: a Randomized Controlled Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- aesthetic evaluation of both surgical methods
研究概览
简要总结
In this study, the conventional SDG method applied to increase the adherent gingival band and partial de-epithelialized SDG methods were evaluated in terms of aesthetics and color compatibility of the recipient area with adjacent tissues.
This study is a controlled double-blind clinical trial randomized by split-mouth, envelope method.Clinical parameters and aesthetic harmony were compared at postoperative 1st, 3rd and 6th months after surgical procedures.Color harmony evaluation was made in 2 different ways, both by photo analysis of a blind researcher using computer software and by visual evaluation of the same blind researcher.
详细描述
The primary aim of this split mouth randomized controlled clinical trial is to compare the partial de-epithelialized free gingival grafting technique with the conventional free gingival grafting technique from an aesthetic point of view. The secondary aim of the study is to evaluate both techniques in terms of periodontal clinical parameters.
This study is a controlled double-blind clinical trial randomized by split-mouth, envelope method. Fifteen patients with attached gingiva width ≤2 mm in the lower jaw bilateral canine and premolar regions were included in the study. De-epithelialized free gingival grafts were applied to the region determined by envelope randomization, and conventional free gingival grafts were applied to the other region. The areas of the patients with insufficient attached gingiva were photographed before the operation, post-op 1st, 3rd, and 6th months, and visual aesthetic evaluations were made with photo analyzes. Clinical parameters such as keratinized gingival width, probing pocket depth, and recession depths were recorded at baseline and at 6 months. Results were represented as mean ± standard deviation and median, and a p value of <0,05 was considered statistically significant.
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
- Double (Participant, 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
- •Absence of known systemic disease
- •Not using any medication that may affect the periodontal tissues or prolong the bleeding time
- •Having not previously operated on the palate area, which is both the receiving area and the donor area.
- •The depth of the probing sulcus of all teeth is <3 mm
- •Whole mouth plaque index and gingival index scores <1
- •The teeth in the operation area are vital
- •Absence of caries and / or restoration on the root surfaces of the teeth in the operation area
- •Lack of attached gingiva in opposite jaws
排除标准
- •Pregnant or lactating women,
- •Smoking individuals,
- •Individuals under the age of 18
结局指标
主要结局
aesthetic evaluation of both surgical methods
时间窗: change in post-op 6 months
Aesthetic evaluation of both surgical methods was done by a blinded researcher by photo analysis. For photo analysis, photographs of the recipient area were taken at the beginning and 6 months after the operation with the help of Adobe Photoshop program and evaluated on these photographs.
次要结局
- clinical parameters(change in post-op 6 months)
研究者
Yonca Naziker
Principal investigator Yonca Naziker
Izmir Katip Celebi University