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临床试验/NCT02143375
NCT02143375已完成1 期

Efficacy of810 nm Diode Laser on Gingival Pigmentation

Shahid Beheshti University of Medical Sciences2 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2013年4月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
19
试验地点
2
主要终点
improvement of gingival pigmentation

研究概览

简要总结

Physiologic gingival pigmentation(PGP) is the most common type of gingival pigmentation and cosmetic concern particularly in gummy smile patients. Laser therapy is an effective and noninvasive treatment option. The aim of this study was to evaluate the efficacy of diod laser on the treatment of PGP in patients.

详细描述

Preoperative and postoperative photographic and clinical observations about the gingival melanin pigmentation were made according to Dummett-Gupta Oral Pigmentation Index scoring criteria given by Dummett C.O. in 1964 The investigators classified pigmented gingiva in patients as:

  1. Mild:Pink to slightly brown
  2. Moderate:Deep brown or black
  3. Severe:Mixed in color Score in each tooth was taken including one full inter dental papilla. Observations were made in natural light. The assessment of the scoring of the pigmentation index were done by all the three examiners, and the agreed upon score was assigned to prevent individual variations.

The investigators compared the intensity of pigmentation in each patient in recall sessions after 1month and 3mounth postoperative.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 19 adult patients who had been referred to oral medicine department of Shahid Beheshti dental school with the chief complaint of melanin pigmentation were selected for inclusion in this study.

排除标准

  • Hyperpigmentation that was associated with systemic disease or drug administration,disease that could compromise wound healing (uncontrolled diabetes, autoimmune disease)
  • Pregnancy or lactation
  • Evidence of relationship between hyperpigmentation and malignancy
  • History of previous treatment of hyperpigmentation
  • Periodontal problems

结局指标

主要结局

improvement of gingival pigmentation

时间窗: 1 month

standard digital photographs were taken preoperative,1 month after laser therapy.

次要结局

  • changes in pigmentation based on standard digital photographs and index of Dummett et al.(3month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Somayyeh Babaei

Dr

Shahid Beheshti University of Medical Sciences

研究点 (2)

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