Platelet Rich Fibrin in the Treatment of Palatal Wounds After Epithelialized Free Gingival Grafts Harvesting. A Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- The primary outcome is to assess the time needed to obtain a complete re epithelialization of the palatal wound
研究概览
简要总结
In this study it will be investigated the usefulness of Platelet-Rich Fibrin (PRF) on in the epithelialized connective tissue graft palatal donor site healing acceleration and in the patient's morbidity reduction. Forty patients, with at least one gingival recession will be treated by a coronally advanced flap (CAF) with connective tissue graft(CTG) resulting from the de-epithelialization of a free gingival graft. In the test group (20 patients) a quadruple layer of PRF membrane will be placed over the palatal wounds; conversely, the control group patients will be treated by an absorbable gelatin sponge. Patients will be monitored at 1, 2, 3 and 4 weeks after surgery for the complete re-epithelialization of the palatal wound (CWE), the alteration of sensibility (AS) around the wound area, the post-operative discomfort (D), and the changes of feeding habits (CFH) by a visual analogic scale (VAS) evaluation. Furthermore, the analgesics consumption and the existence of delayed bleeding from the palatal wound (DWB) during the first post-operative week will be assessed.
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 (Participant)
入排标准
- 年龄范围
- — 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •are as follows:
- •to have a single gingival recession to be treated by a mucogingival surgery intervention
- •to be in good systemic health
- •to have a good oral hygiene
排除标准
- •no systemic diseases; no coagulation disorders; no medications affecting periodontal status in the previous 6 months; no pregnancy or lactation;
- •no smoking habits;
- •no periodontal surgery on the experimental sites;
- •no inadequate endodontic treatment
- •no tooth mobility at the site of surgery
结局指标
主要结局
The primary outcome is to assess the time needed to obtain a complete re epithelialization of the palatal wound
时间窗: four weeks
次要结局
未报告次要终点
研究者
Michele Paolantonio
Full time professor
G. d'Annunzio University