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临床试验/NCT05304624
NCT05304624已完成不适用

Comparison of Er,Cr:YSGG Laser and Diode Laser in the Treatment of Gingival Melanin Pigmentation: Randomised Clinical Trial

Okan University2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2020年12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
22
试验地点
2
主要终点
depigmentation with two different laser devices

研究概览

简要总结

The main aim of this paper is to explore the efficiancy on the extention and density of pigmentation between diode and Er,Cr:YSGG lasers. The second aim of this study was to investigate the lasers effects of patient pain and comfort.

详细描述

Recently, soft tissue aesthetics has become an important issue in dentistry. The normal physiological color of the gingiva is coral pink or pale pink. The color of gingiva is determined by several factors, including thickness of ephitelium, degree of keratinization, the number and size of underlying blood vessels and pigments within the epithelium. Gingival hyperpigmentation is caused by excessive deposition of melanin located in the basal and suprabasal cell layers of the epithelium. Many etiological factors such as smoking can stimulate melanin pigmentation. It has been reported that polycyclic amines such as nicotine and benzopyrene, which are known to penetrate melanocytes and bind to melanin, in cigarettes cause stimulation of melanocytes and as a result increase melanin production. Smoker melanocyte pigmentation was described first time by Hedin in 1977 as 'a local benign melanin pigmentation often seen in the attached gingiva'. Although physiologic melanin pigmentation and smoker melanosis are not medical problems, patients seek treatment for esthetic purposes. Various depigmentation techniques are employed to address the aesthetic concerns of individuals. Methods used for depigmentation: Chemical treatment, electrosurgery, abrasion with diamond tools, scalpel technique, gingivectomy, gingival graft, cryosurgery and lasers. Which method to choose depends on clinical experience and individual preferences. However, most researchers consider laser ablation to be more effective, convenient, and safer for gingival depigmentation. Many laser systems such as CO2 laser, Diyot laser, Neodymium Doped:Yttrium Aluminum Garnet(Nd:YAG) laser, Erbium Doped:Yttrium Aluminum Garnet(Er:YAG) laser and Erbium Chromium-Doped:Yttrium, Scandium, Gallium, Garnet(Er,Cr:YSGG) are used for this purpose. In melanin depigmentation with laser, the ability melanocytes which containing melanin to absorb the laser beam depends on the wavelength and water. The wavelength of the Er,Cr:YSGG laser is 2780nm, while the wavelength of the diode laser is 810-980nm.10 While diode laser is used for soft tissue surgery, Er,Cr:YSGG laser is used for soft and hard tissue surgery. Although there are more case reports regarding the use of diode lasers in gingival depigmentation, only a few focus on the use of Er, Cr:YSGG laser. In this study; in the treatment of gingival depigmentation by use of Er, Cr: YSGG laser and Diode laser to patients, it was aimed to evaluate the satisfaction of the patients during and after the operation, to evaluate the change in gingival tissue thickness and to evaluate the rate of repigmentation.

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)

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with systemic healthy or not taking any medication
  • Patients who are not pregnant or breastfeeding
  • Patients between 18-40 years old
  • Physiologic gingival hyperpigmentation on the facial aspect of maxillary first right premolar to first left premolar region
  • Patients with esthetic concerns
  • Patients who have smoked at least 10 cigarettes per day for at least 5 years
  • Periodontally healthy patients

排除标准

  • Patients with any systemic diseases or taking any medication
  • Pregnant and lactating women
  • Patients under 18 years
  • Patients without gingival melanin pigmentation on the facial aspect of maxillary first right premolar to first left premolar region
  • Patients who smoke less than 5 years and/or less than 10 cigarettes per day
  • Non-smokers
  • Patients with any metallic restoration or undergoing orthodontic treatment

结局指标

主要结局

depigmentation with two different laser devices

时间窗: 1 year

Dummett Oral Pigmentasyon Indeks (DOPI) tehat identifies pigmentation as score 1- no clinical pigmentation (pink tissue), score 2-mild clinical pigmentation (light brown), score 3-moderate clinical pigmentation (mixed brown and pink), and score 4-heavy clinical pigmentation (deep brown to bluish black). Photographic Image Assesment: All photographs were taken in a standardized environment by using a Canon EOS 700D with Macro Lens EF 100 mm with automatic focusing. All photographs were taken at a standard distance which was 30 cm as recorded from the patient's cental teeth to the edge of the camera lens. The periodontal probe was used for the calibration of intraoral photographs. Photographs were analyzed with ImageJ Software version10.2. The pigmented areas on the photograph will be calculated in mm2.

次要结局

  • Patient Esthetic Satisfaction(1 year)
  • Pain Perception(1 year)

研究者

发起方
Okan University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ekin Besiroglu

assistant profesor

Okan University

研究点 (2)

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