Comparison of Gingival Depigmentation Using Microneedling and Microneedling With Glutathione Gel - A Split Mouth Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Assessment of Gingival pigmentation using SEMPI index
研究概览
简要总结
The colour of gingiva is important determinant of smile esthetics.Owing to increasing awareness and demand for cosmetic procedures over the past decade, gingival depigmentation has gained popularity among periodontal plastic surgical procedures.
详细描述
various treatment modalities for depigmentation has been used over the decades. Microneedling is a minimally invasive procedure that creates micro pores on the gingiva which stimulates the natural healing process and improve penetration of topical agents.Glutathione when used has shown promising results in reducing pigmentation which is a major concern with the treatment. In this study 15 patients meeting the eligibility criteria has been randomly assigned to either of the arms.
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
- Double (Participant, 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
- 否
入选标准
- •Patients between the age group of 18 to 45 years
- •Systemically healthy subjects
- •Maxillary or mandibular keratinised gingiva with minimum mean SEMPI score of 1(light grey / brown pigmentation) and above.
排除标准
- •Patients with thin gingival phenotype(<1mm)
- •Patients on drugs that cause oral pigmentation like antimalarials,minocycline, oral contraceptives etc.,
- •Systemic disorders that cause oral pigmentation ,Pregnant and lactating women
- •Subjects with history of smoking.
研究组 & 干预措施
Microneedling using Dermapen device
干预措施: Microneedling using Dermapen device (Device)
Microneedling with 0.5% Glutathione gel
In this arm dermapen device is used to reduce pigmentation
干预措施: Microneedling using Dermapen device (Device)
Microneedling with 0.5% Glutathione gel
In this arm dermapen device is used to reduce pigmentation
干预措施: Microneedling with 0.5 % Glutathione gel (Other)
结局指标
主要结局
Assessment of Gingival pigmentation using SEMPI index
时间窗: baseline, 1 month, 3 months, 6 months
Severity and Extension of Gingival Melanotic Pigmentation Index is used for assessing the gingival pigmentation
Assessment of pigment surface area using Image J analysis software
时间窗: baseline, 1 month, 3 months, 6 months
次要结局
- Rate of repigmentation(6 months)
- patient reported pain or discomfort(at the time of treatment , 1 month)
研究者
Dr Prabhuji MLV
Head of Department of Periodontology
Krishnadevaraya College of Dental Sciences & Hospital