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临床试验/NCT03104764
NCT03104764已完成不适用

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

Public Dental Health in Uppsala Region2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2014年8月1日最近更新:
适应症

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

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)

研究者

发起方
Public Dental Health in Uppsala Region
申办方类型
Other
责任方
Sponsor

研究点 (2)

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