Microneedling With Platelet Rich Plasma Versus Microneedling Alone For Gingival Depigmentation: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 32
研究概览
简要总结
To evaluate the usage of microneedling with platelet rich plasma as a gingival depigmentation method in comparison to microneedling alone for pigment intensity reduction.
Pre-operative preparation phase includes ultrasonic scaling and oral hygiene instructions for all patients. Eligible patients will be randomly allocated into two groups.
Clinical photographs: Clinical photographs will be taken at baseline, 1 and 6 months postoperatively.
Intervention Group (Group A): Microneedling will be done with application of Platelet Rich Plasma for depigmentation.
Control Group (Group B): microneedling will be done alone for depigmentation.
详细描述
In both groups:
Local anesthesia (Articaine with 1:100,000 Epinephrine( will be administered by infiltration technique).
A Dermapen device will be used to microneedle the gingival tissue (model M8) with 24 microneedles arranged in rows, which is adjusted according to the gingival thickness at the 6th mode speed of 700 cycles/min.
It will be laid perpendicular to gingival surface and MN will be carried out in horizontal, vertical and diagonal directions about four to five times for the whole hyperpigmented gingiva until mild microbleeding and mild erythema was clearly visible.
Once bleeding points are observed on all areas of the pigmented gingiva, it will be irrigated using saline solution and dried using sterile gauze.
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
- 否
入选标准
- •• Patients exhibiting melanin hyperpigmentation in the anterior region of the upper or lower gingiva.
- •Age ≥ 18 year old.
- •Patients should be free from any systemic diseases according to modified Cornell Medical index (Abramson 1966).
- •Non- smokers
排除标准
- •• Fully edentulous patients.
- •Patients with endocrine disorders causing hyperpigmentation or drug induced gingival pigmentation. (Sreeja, Ramakrishnan et al. 2015)
- •Pregnant or lactating females.
研究者
Abdelrahman Sameer Abdullah
principal investigator
Cairo University