Microvascular Response to the Harvest of Free Gingival Grafts With or Without the Application of Hemostatic Sutures: a Randomized Controlled Clinical Trial Assessing Palatal Blood Flow by Laser Speckle Contrast Imaging
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Palatal microvascular healing
研究概览
简要总结
Randomized, single-center trial with 2 parallel arms and a 1:1 allocation ratio, with the aim of comparing clinical and microvascular healing and patients related outcomes, which follow the harvest of a free gingival graft, where hemostasis has been achieved with either compressive sutures and homeostatic sponges (control) or with a simplified suture-less approach (test).
详细描述
This randomized two parallel arms controlled clinical trial aims to establish the early microvascular healing, clinical healing, and patients related outcomes, which follow the harvest of a free gingival graft, where hemostasis has been achieved with either compressive sutures and homeostatic sponges (control) or with a simplified suture-less approach (test). The primary outcome is the microvascular healing of the palate14 days after surgery, assessed by measuring the palatal blood flow with a Laser Speckle Contrast Imaging (LSI), expressed in Laser Speckle Perfusion Units (LSPU). Secondary outcomes include the palatal blood flow at 3, 7 and 30 days after surgery, the clinical healing of the palate, the occurrence of postoperative bleeding and patients related outcome measures assessed 14 postoperative days. A figure of 16 subjects per group was obtained based on an expected difference of 7 LSPU, considering a SD of 6.3 SLPU, 80% power, alpha 0.05, and assuming a foreseen drop-out rate of 15%. Patients will be randomly allocated to two groups: test (simplified suture-less approach) and control (compressive sutures and homeostatic sponges). Cases will be the unit of analysis and T-student (normal distribution) or U Mann Whitney (non normal distribution or non parametric variables) will be performed setting the significance level at p < 0.05.
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 (Care Provider)
盲法说明
Allocation to the test or control group will be revealed to the surgeon only after completing the harvest of the free gingival graft.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any adult (≥ 18 year old), male or female patient from the University Complutense of Madrid, being able to sign an informed consent form, presenting any mucogingival condition requiring the placement of a free gingival graft or a connective tissue graft obtained through the extra oral de-epithelialization of a free gingival graft.
排除标准
- •Patients fitting to all the above inclusion criteria will be excluded from the study if unable to attend to the study-related procedures (including the follow-up visits) or if one or more of the following systemic or local exclusion criteria will be found at any time through the study:
- •Systemic primary exclusion criteria:
- •Compromised general health status contraindicating the study procedures (≥ASA IV);
- •Drug abuse, alcohol abuse, or smoking > 10 cigarettes a day;
- •Chronic use of corticosteroids, NSAIDs, or immune-modulators (any type, any dose);
- •Use of anti-aggregant or anti-coagulant drugs;
- •Pregnant or nursing women;
- •Hypersensitivity to ibuprofen.
- •Local primary exclusion criteria:
- •History of previous soft tissue surgeries in the area of the harvest;
- •Preoperative evidence of a palate thickness < 2mm in the area of interest;
- •Intraoperative evidence of active bleeding from the harvesting site at the end of surgery, which impedes the stabilisation of a good coagulum over the harvesting area;
- •Secondary exclusion criteria:
- •a. Non compliant patients: poor oral hygiene (FMPS >20%) at 2 consecutive visits.
结局指标
主要结局
Palatal microvascular healing
时间窗: before surgery, 3 days after surgery, 7 days after surgery, 14 days after surgery, 30 days after surgery
Changes in the palatal blood flow measured with Laser Speckle Contrast Imaging (LSI), expressed in Laser Speckle Perfusion Units (LSPU)
次要结局
- Postoperative bleeding(14 days after surgery)
- Wound healing VAS at the donor site(7 days after surgery, 14 days after surgery, 30 days after surgery)
- Patients related outcomes measures (PROMS)(14 days after surgery)
- Patients consumption of analgesic rescue medication(14 days after surgery)
- Wound healing index at the donor site(7 days after surgery, 14 days after surgery, 30 days after surgery)