Gingival Depigmentation Using Diode Laser 940nm Versus 980nm: A Split-mouth Comparative Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Intensity of pigmentation
研究概览
简要总结
is study aimed to evaluate the effectiveness of two diode lasers of different wave lengths 940nm and 980nm for the treatment of physiologic gingival melanin hyperpigmentation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of both sexes diagnosed clinically with physiologic gingival pigmentation.
- •Pigmentation extending from canine to canine in either upper or lower arch.
排除标准
- •Patients with uncontrolled metabolic disease.
- •Immuno-compromised patients.
- •Patients with renal disease.
- •Patients having coagulation disorders.
- •Pregnant and lactating women.
- •Evidence about the relation of pigmentation with malignancies.
- •History of previous treatment of gingival pigmentation.
研究组 & 干预措施
940nm wavelength Diode laser
干预措施: Biolase Epic X 940nm wavelength Diode laser (Device)
980nm wavelength Diode laser
干预措施: Doctor smile simpler 980nm wavelength Diode laser (Device)
结局指标
主要结局
Intensity of pigmentation
时间窗: up to 12 weeks
Intensity of pigmentation was assessed with Dummett Oral Pigmentation Index (DOPI 1971). DOPI was scored as: Score 1: No clinical pigmentation (pink gingiva) Score 2: Mild clinical pigmentation (mild light brown color) Score 3: Moderate clinical pigmentation (medium brown or mixed pink and brown) Score 4: Heavy clinical pigmentation (deep brown or bluish black).
Extension of pigmentation
时间窗: up to 12 weeks
Extension of pigmented area was assessed by, Hedin Melanin Index (HMI). It was scored as: Degree 1: Isolated-only 1 or 2 pigmented interdental papillae Degree 2: Numerous pigmented interdental papillae Degree 3: Short continuous ribbons Degree 4: Long continuous ribbon
次要结局
未报告次要终点
研究者
Nourhan M.Aly
Assistant Lecturer of Dental Public Health
University of Alexandria