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临床试验/NCT05608057
NCT05608057已完成不适用

Vitamin C Mesotherapy Versus Diode Laser for the Management of Physiologic Gingival Pigmentation (Randomized Controlled Clinical Trial)

Hams Hamed Abdelrahman1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2022年10月22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
26
试验地点
1
主要终点
Change in gingival pigmentation score

研究概览

简要总结

Physiologic pigmentation affects the gingival esthetics. Laser ablation has been recently used as the most effective and reliable technique for gingival depigmentation. However, the high cost of laser technology limits its use in dental practice. Vitamin C/Ascorbic acid mesotherapy has been proposed as a minimally invasive, safe, cost-effective new modality of treatment.

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 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Adults between 18 and 45 years old with physiologic melanin pigmentation in the anterior esthetic portion of the maxillary or mandibular gingiva.
  • Systemically free

排除标准

  • Drugs intake, which associates with gingival melanin pigmentation.
  • Pregnant and lactating women.
  • Patients with known hypersensitivity to ascorbic acid.
  • Patients with bad oral hygiene.
  • Pigmentation of the gingiva due to heavy metal ingestion

结局指标

主要结局

Change in gingival pigmentation score

时间窗: baseline, 1 month, 2 months

Score 0: Absence of pigmentation Score 1: Spots of brown to black color or pigments. Score 2: Brown to black patches but not diffuse pigmentation Score 3: Diffuse brown to black pigmentation, marginal, and attached gingiva

次要结局

  • Change in pain score(up to 1 week)
  • Patient satisfaction(after 2 months)

研究者

发起方
Hams Hamed Abdelrahman
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Hams Hamed Abdelrahman

Assistant lecturer of DPH and Clinical statistician

Alexandria University

研究点 (1)

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