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临床试验/NCT04811144
NCT04811144已完成不适用

Clinical Application of Er:YAG Dental Laser System

Kaohsiung Medical University Chung-Ho Memorial Hospital2 个研究点 分布在 1 个国家目标入组 129 人开始时间: 2017年12月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
129
试验地点
2
主要终点
pain index

研究概览

简要总结

The study aim was to evaluate the effectiveness of Er:YAG dental laser treatment modality for cavity, sensitive teeth, abnormal frenum attachment and peri-implantitis.

详细描述

There are four indications will be included in this plan. They are Cavity, Sensitive Teeth, Abnormal Frenum Attachment and Peri-implantitis. Each indication has different procedures which are listed as below:

Cavity: history records, affected range check, X-ray&photo, treatment, pain index check, return visit check after two weeks. Sensitive Teeth: history records, sensitive check, X-ray&photo, treatment, pain index and effectiveness check, return visit check after two weeks. Abnormal Frenum Attachment: history records, abnormal position check, photo, cutting, pain index check, return visit check after three, five and seven days. Peri-implantitis: History records, measure periodontal pocket depth, anaerobes collect, X-ray, photo, CT, treatment, pain index check, return visit check after one week, two weeks, four weeks and three months, six months check the effectiveness and collect anaerobes during every return visit. In the last return visit, X-ray and CT would be included.

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
20 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Ages: 20 years and above。
  • Patients are available for multiple follow-up visits for the duration of the study.
  • Having the mental ability to express informed consent.
  • Patients clinically diagnosed as having Cavity, Sensitive Teeth, Abnormal Frenum Attachment or Peri-implantitis.

排除标准

  • Severe diabetes and chronic diseases are excluded.
  • CVA patients or the patients taking anti-rejection medicine and osteoporosis drugs for long-term should be excluded.
  • Patient who suffer from photodermatosis and photosensitive patients (photoallergic).
  • The health condition is not well after health education and physical therapy are excluded.
  • Surgery on patients with serious diseases of the hemopoietic system (such as haemophilia and leukaemia).
  • Malignant tumours, obligate precancerous tumours, hemangiomas.
  • Coronary heart disease and chronic obstructive pulmonary diseases are excluded.
  • Pregnant woman.

结局指标

主要结局

pain index

时间窗: two weeks

The Numeric Rating Scale (NRS-11) is an 11-point scale for patient self-reporting of pain. It is based solely on the ability to perform activities of daily living (ADLs) and can be used for adults and children 10 years old or older

sensitive check

时间窗: two weeks

The dentist asked participants few questions about dental status. Do you feel sudden discomfort in your teeth when you drink hot or cold beverages you once considered normal?

Abnormal Frenum Attachment

时间窗: a week

wound healing status

Probing depth

时间窗: six months

dentist measurement participant's probing depth the distance from the gingival margin to pocket base

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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