跳至主要内容
临床试验/CTRI/2025/07/091201
CTRI/2025/07/091201尚未招募Phase 3 4

Evaluation of Mesotherapy and Diode Laser for Gingival Depigmentation: An Ambispective Study

Center for Dental Education and Research1 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2025年7月20日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
19
试验地点
1
主要终点
Reduction in gingival pigmentation, measured using the Dummett Oral Pigmentation Index (DOPI)

研究概览

简要总结

Non-surgical approaches as well as surgical intervention have been proposed for the management of melanin pigmentation. The surgical approaches depend mainly on the de-epithelization of the target region. It could be performed utilizing various techniques as free gingival grafts, gingivectomy or de-epithelialization using bur abrasion, surgical blade, laser and cryosurgery. Laser especially diode laser was the most frequently used technique and showed better esthetic outcomes, less pain, faster healing and most important patients’ preference and satisfaction after treatment. However, lasers were associated with more recurrence at 6-month follow-up. Therefore, there is a need to other

minimally invasive non-surgical therapeutic option in order to depigment such conditions.

研究设计

研究类型
Interventional
分配方式
Na
盲法
Outcome Assessor Blinded

入排标准

年龄范围
20.00 Year(s) 至 40.00 Year(s)(—)
性别
All

入选标准

  • Subjects of either gender between the age range of 20-40 years
  • Physiological gingival pigmentation in anterior maxillary and mandibular region
  • DOPI score between 1-3
  • ASA grade 1 individuals.

排除标准

  • 未提供

结局指标

主要结局

Reduction in gingival pigmentation, measured using the Dummett Oral Pigmentation Index (DOPI)

时间窗: Absence of re-pigmentation at 3-month follow-up

Absence of repigmentation, assessed through clinical examination

时间窗: Absence of re-pigmentation at 3-month follow-up

次要结局

未报告次要终点

研究者

发起方
Center for Dental Education and Research
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Nirav Vyas

All India Institute of Medical Sciences, New Delhi

研究点 (1)

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