The Effects of Cyanoacrylate on Self-reported Outcomes and Healing Following Free Gingival Graft Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Oral health impact profile (OHIP-14)
研究概览
简要总结
Present study aims to reveal the effects of cyanoacrylate application at the recipient bed and the donor site in free gingival graft surgery on the healing parameters and patient-based outcomes.
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
- 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
- •Single-tooth gingival recession in the anterior mandibular region
- •Pain with chewing or oral hygiene practice
- •Ongoing recession
排除标准
- •Systemic disease
- •Pregnancy / lactation
研究组 & 干预措施
Cyanoacrylate
The graft is stabilized and the donor site is coated with cyanoacrylate.
干预措施: Free gingival graft (Procedure)
Cyanoacrylate
The graft is stabilized and the donor site is coated with cyanoacrylate.
干预措施: Cyanoacrylate (Procedure)
Suture
6/0 polyvinylidene fluoride sutures are used for stabilization, while the donor site is left untreated.
干预措施: Free gingival graft (Procedure)
Suture
6/0 polyvinylidene fluoride sutures are used for stabilization, while the donor site is left untreated.
干预措施: Suture (Procedure)
结局指标
主要结局
Oral health impact profile (OHIP-14)
时间窗: 1st month
The patients are asked to fill provided OHIP-14 forms Questionnaire about satisfaction related to oral health, scored as 0-4 (never - always) 14 questions in total 0 (min.) - 56 (max.) Lower scores represent higher oral health related life quality
Re-epithelization
时间窗: three weeks after the surgery
Donor site re-epithelization: hydrogen-peroxide is applied to the donor area with the help of an injector, and it is recorded as complete when no foaming occurs
Post-operative pain
时间窗: 4th week
Visual analogue scale (VAS) (0-10), self-reported outcome 0 - no pain (min.) 10 - unbearable (max.)
Graft dimensions
时间窗: 6th month
Mesio-distal (horizontal) and apico-coronal (vertical) width of the graft is measured with a periodontal probe, rounding to the nearest mm
Re-epithelization
时间窗: one week after the surgery
Donor site re-epithelization: hydrogen-peroxide is applied to the donor area with the help of an injector, and it is recorded as complete when no foaming occurs
Re-epithelization
时间窗: two weeks after the surgery
Donor site re-epithelization: hydrogen-peroxide is applied to the donor area with the help of an injector, and it is recorded as complete when no foaming occurs
Post-operative pain
时间窗: 1st week
Visual analogue scale (VAS) (0-10), self-reported outcome 0 - no pain (min.) 10 - unbearable (max.)
Post-operative pain
时间窗: 2nd week
Visual analogue scale (VAS) (0-10), self-reported outcome 0 - no pain (min.) 10 - unbearable (max.)
Post-operative pain
时间窗: 3rd week
Visual analogue scale (VAS) (0-10), self-reported outcome 0 - no pain (min.) 10 - unbearable (max.)
Oral health impact profile (OHIP-14)
时间窗: Baseline
The patients are asked to fill provided OHIP-14 forms Questionnaire about satisfaction related to oral health, scored as 0-4 (never - always) 14 questions in total 0 (min.) - 56 (max.) Lower scores represent higher oral health related life quality
Oral health impact profile (OHIP-14)
时间窗: 3rd day
The patients are asked to fill provided OHIP-14 forms Questionnaire about satisfaction related to oral health, scored as 0-4 (never - always) 14 questions in total 0 (min.) - 56 (max.) Lower scores represent higher oral health related life quality
Oral health impact profile (OHIP-14)
时间窗: 1st week
The patients are asked to fill provided OHIP-14 forms Questionnaire about satisfaction related to oral health, scored as 0-4 (never - always) 14 questions in total 0 (min.) - 56 (max.) Lower scores represent higher oral health related life quality
Graft dimensions
时间窗: 1st month
Mesio-distal (horizontal) and apico-coronal (vertical) width of the graft is measured with a periodontal probe, rounding to the nearest mm
Graft dimensions
时间窗: 3rd month
Mesio-distal (horizontal) and apico-coronal (vertical) width of the graft is measured with a periodontal probe, rounding to the nearest mm
次要结局
- Mucosal thickness(In the beginning of the surgery (baseline))
- Paresthesia / hyperesthesia in the donor site(1st month)
- Color harmony(6th month)
- Color harmony(1st week)
- Color harmony(2nd week)
- Color harmony(1st month)
- Color harmony(3rd month)
研究者
Mustafa YILMAZ
Assistant Professor
Biruni University