Evaluation of Wound Healing and Patients´Experiences of Labial Frenulum Surgery - a Randomized, Controlled Comparative Study of Conventional Scalpel Technique and Er-Yag Laser Technique
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Wound healing
研究概览
简要总结
The aim of the study was to compare the outcome in terms of wound healing time, surgery time, bleeding and patient experience of the ectomy of frenulum when performed with laser technology versus conventional scalpel technique. A prospective, single-blind, randomized and controlled study was performed. Wound healing was assessed five and ten days after after surgery. The long-term outcome were assessed blinded by a dentist not earlier involved in the study.
详细描述
Children referred to a pediatric clinic to surgically remove a labial frenulum were randomized to treatment with conventional scalpel or laser treatment technology after parents and children had given consent to participate. During the surgery the time required for the procedure and the amount of bleeding the different techniques caused were measured. Wound healing was assessed five and ten days after surgery by a clinical judgement and by analysing photos. Three months after surgery an independent dentist assessed the long-term outcome by a clinical examination. The patients´ view of the treatment were assessed directly after the surgery and five days, ten days and three months after the surgery.
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 (Outcomes Assessor)
盲法说明
The outcome assessor have not met the patient before assessing the outcome. The assessor has no information about which surgical technique that is used.
入排标准
- 年龄范围
- 7 Years 至 15 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients in need of frenulum labials surgery
排除标准
- •patients with severe general diseases (ASA>2)
- •patients who required general anaesthesia for treatment
结局指标
主要结局
Wound healing
时间窗: 0-3 months
Time period until reepithelialized measured clinically and on photos
次要结局
- Patient experience(0-3 months)
- Time required for surgery(Intervention day)
- Scar tissue formation(3 months)
