Healing After Connective Tissue Graft Harvesting in the Palatal Area With and Without Suture: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Early healing index
研究概览
简要总结
This study evaluated the outcomes in the early healing of palatal wounds after harvesting a subepithelial connective tissue graft (SCTG) using the single incision technique with placement of a collagen haemostatic sponge (CHS) without suturing the palate. The primary outcome of this study was to evaluate the early wound healing index (EHI).
详细描述
The aim of this study was to compare the outcomes in the early wound healing after harvesting a subepithelial connective tissue graft (SCTG) using the single incision technique and collagen haemostatic sponge (CHS) placement, with and without suturing the palate. 36 subjects were randomized to receive (n=18, Suture group-SG) or not a suture (n=18, no Suture group-nSG). Outcomes variables were: Early healing index (EHI) at 7, 14 and 30 days, self-reported pain using a visual analogue scale (VAS) at 7 and 14 days, immediate (iB) and delayed bleeding (dB). Data obtained were compared by Fisher's exact test, T test for independent sample, Mann-Whitney test (U test) and Wilcoxon sign test as appropriate. The level of significance was set at p < 0.05. Statistical analysis was performed with Infostat version 2015.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects with an indication of mucogingival surgery for single gingival recession treatment that required harvesting a subepithelial connective tissue graft
- •Age >18 years ≤ 60 years.
- •Periodontally and systemically healthy.
- •Palatal fibromucosa width ≥ 2mm evaluated with a North Carolina probe placed perpendicular to the hard palate, prior to surgery.
排除标准
- •Contraindications for periodontal surgery.
- •Subjects presenting coagulation disorders (history of Haemophilia, von Willebrand disease or anticoagulant therapy).
- •Subjects taking medications known to interfere with periodontal tissue health or healing.
- •Subjects that had been operated on the palate (connective tissue removed) previously from that same donor area.
结局指标
主要结局
Early healing index
时间窗: Day 30 post surgery
1\. Complete flap closure without fibrin line at the palate; 2. Complete flap closure with fibrin line at the palate; 3. Complete flap closure with small fibrin clot(s) at the palate; 4. Incomplete flap closure with partial necrosis of the palatal tissue; 5. Incomplete flap closure with complete necrosis of the palatal tissue.
次要结局
- Pain level / discomfort(second week after surgery,)
- Number of participants with immediate bleeding(immediately postsurgery)
- Number of participants with delayed bleeding(7 days post surgery)
研究者
Mariel Viviana Gómez
Associate Professor. Department of Postgraduate Periodontics.
Maimonides University