Comparison of Diode and Er,Cr:YSGG Lasers in Gingival Depigmentation: a Split-mouth Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Change in gingival pigmentation measured by Dummett-Gupta Oral Pigmentation Index (DOPI)
研究概览
简要总结
Gingival hyperpigmentation is a common physiological condition caused by excessive melanin deposition in oral mucosa, negatively affecting smile esthetics. Laser therapy has become an effective treatment option due to advantages such as minimal bleeding, reduced postoperative discomfort, and faster healing.
This clinical study aims to evaluate clinical characteristics of gingival pigmentation and compare treatment outcomes between diode laser and Er,Cr:YSGG laser techniques. Outcomes include pigmentation reduction, postoperative pain, wound healing, bleeding, patient satisfaction, and recurrence rate.
详细描述
Gingival depigmentation is widely performed to improve smile esthetics in patients with excessive melanin pigmentation. Various treatment modalities have been proposed, including scalpel surgery, electrosurgery, cryotherapy, and laser therapy. Among these, diode laser and Er,Cr:YSGG laser have demonstrated promising results due to selective absorption by pigmented tissues and minimal tissue trauma.
This interventional clinical study compares two laser systems for treatment of gingival pigmentation. Clinical indices such as DOPI (Dummett-Gupta Oral Pigmentation Index), MPI (Melanin Pigmentation Index), postoperative pain (VAS scale), bleeding, wound healing (Landry index), and patient satisfaction will be evaluated at multiple follow-up time points including baseline, 1 day, 7 days, 1 month, and 3 months.
The study aims to determine the more effective laser modality in improving esthetic outcomes and minimizing complications.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •all patients exhibiting physiological melanin hyperpigmentation of score 1 or more according to the oral pigmentation index (DOPI) in the buccal maxillary gingiva
排除标准
- •history of systemic diseases related to pathology
- •participants with a systemic condition that could affect tissue healing (e.g., uncontrolled diabetes, autoimmune diseases, HIV, leukemia, etc.)
- •pregnancy and lactation
- •a history of smoking; previously used drugs (related to pigmentation) before the intervention within the last 6 months
- •contraindication for laser treatment.
研究组 & 干预措施
Er,Cr:YSGG
This group treated with an erbium chromium-doped: yttrium, scandium, gallium, garnet (Er,Cr:YSGG) laser at 2780 nm
干预措施: Er,Cr:YSGG laser (Device)
Diode
This group treated with 940 nm diode laser.
干预措施: Diode laser (Other)
结局指标
主要结局
Change in gingival pigmentation measured by Dummett-Gupta Oral Pigmentation Index (DOPI)
时间窗: Baseline, 7 days, 1 month, 3 months
Assessment of gingival pigmentation using the DOPI score.
Change in gingival pigmentation measured by Melanin Pigmentation Index (MPI)
时间窗: Baseline, 7 days, 1 month, 3 months
Assessment of gingival pigmentation using the MPI score.
次要结局
- Change in postoperative pain measured by Visual Analog Scale (VAS)(1 day, 7 days)
研究者
Assoc.Prof.Dr. Nguyen Ngoc Rang
Principal Investigator
Can Tho University of Medicine and Pharmacy