A Comparative Randomized Clinical Study on the Recurrence Rate of Gingival Pyogenic Granuloma Treated with Sclerotherapy Versus Diode Laser Therapy.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 主要终点
- Postoperative pain was evaluated (NRS)
研究概览
简要总结
Pyogenic granuloma is a common tumor-like growth of the oral cavity considered to be non-neoplastic in nature. They usually present as a reactive lesion occur in response to chronic and recurring tissue injury, in which capillaries are very prominent commonly seen arising from interdental gingiva. Pyogenic granuloma may occur in all ages, with a peak age of incidence in the second decade of life, more common in young adult females, possibly because of vascular effects of female hormones.
详细描述
Oral PG can be treated by conservative excision. Local irritants or the source of trauma must be eliminated to minimize the risk of recurrence. Although, surgical excision is considered a simple procedure, it might be complicated by several complications such as intraoperative bleeding, and postoperative infection that might delay the healing of the wound. Other treatment modalities such as laser, injection of sclerosing agents have been used.
Laser has proven to be an effective therapy for oral soft tissue pathologies. Moreover, its ability to perform precise incisions, better hemostasias, and less invasive procedures with less discomfort to patients have made it a preferred treatment option for several soft tissue lesions.
Sclerotherapy has been proposed as an effective method of treatment for pyogenic granuloma. Their mechanism of action is endothelial injury, inflammation, thrombosis, fibrosis, and final lesion destruction. Polidocanol is a widely used nonionic detergent sclerosant that was first developed as an anesthetic. It acts through endothelial overhydration, vascular injury, and closure.
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
- •All the subjects were principally diagnosed based on history and clinical features such as oral pyogenic granuloma are selected for this study. Radiographic evaluation was also done to rule out any bony involvement.
- •The sizes of participants' lesions were not less than 5 mm. • Age > 18 years
排除标准
- •Patients were excluded if they had uncontrolled diabetes, renal diseases, coagulation disorders or were allergic to any of the sclerosing drug constituents. Immune-compromised patients and pregnant and lactating women were also excluded from the study.
研究组 & 干预措施
Group 1: Laser-treated group
10 patients will be treated by laser surgery to remove oral granuloma
干预措施: laser therapy (Device)
Sclerotherapy-treated group (group 2)
This group was made up of ten patients who were treated with injections of sclerosing agent to remove pyogenic granuloma
干预措施: Sclerotherapy (Drug)
结局指标
主要结局
Postoperative pain was evaluated (NRS)
时间窗: 3 months
Postoperative pain intensity will be perceived on the 2nd and 7th days using the ten-point Numeric Rating Scale (NRS) interpreted as 0 grade (No pain), 1-3 grade (mild pain), 4-6 grade (moderate pain) and 7-10 grade (severe pain)
Recurrence rate
时间窗: 3 months
Patients will be recalled monthly for 3 months after the end of treatment to evaluate if recurrent occur or not.
Patient compliance (VAS).
时间窗: 3 months
compliance of patients will be assessed on a scale from 1 to 10
次要结局
- Details of side effects(1 week)
研究者
Nashwa Helaly Mohamed
lecturer, Oral medicine, Periodontology and Oral diagnosis
Assiut University