Clinical Evaluation of Microneedling Technique With Topical Application of Silymarin on Gingival Hyperpigmentation in Comparison With Diode Laser and Scalpel Methods. A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Gingival Pigmentation Recurrence
研究概览
简要总结
The present study will be carried to evaluate the efficacy of MN technique with topical Silymarin application in treating gingival hyperpigmentation in comparison with Laser and scalpel methods. This evaluation will be done clinically. The questions to be answered:
- Is there a statistical difference between the microneedling (MN) technique with topical silymarin application, the scalpel technique, and the diode laser in providing clinical and aesthetic advantages in the treatment of gingival pigmentation?
- What medical problems do participants have when using of Silymarin topically?
Participants will be:
Group 1 : The gingiva of the facial surfaces of the selected area will be de-epithelized by conventional method through blades no 15c.
Group 2 : The gingiva of the facial surfaces of the selected area will be de-epithelized by A Diode laser Device (serolaser).
Group 3 : The gingiva of the facial surfaces of the selected area will be treated by repetitive punctures with Dr.Pen ULTIMA - A6 needle tip. Silymarin is applied topically for ten minutes.
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 (Investigator, Outcomes Assessor)
盲法说明
Masking Description
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
- •Patients will be free from any systemic diseases according to criteria of Modified Cornell Medical Index
- •Patient with physiologic pigmentation
- •Patient agree to sign the written consent
- •Both genders
排除标准
- •Pregnant and lactating women
- •Systemic conditions affect melanin production
- •Medications induce pigmentation or enlargement
- •Those with known allergies to silymarin.
研究组 & 干预措施
Conventional Surgical method
depigmentation done using scalpel blade NO15 c
干预措施: Gingival Depigmentation with Conventional Method (Procedure)
Diode Laser
diode lase with wave length 980 and laser tip 320 micron
干预措施: Gingival Depigmentation with Diode Laser (Procedure)
MN with Silymarin application
micro needling device Dr.Pen ULTIMA- M8 needle tip. The needle tip features six speed settings,ranging from 412 to 700 cycles per minute, with 12-24 needles arranged in rows. Healthcare professionals can treat areas in back and forth motion for 30 40 seconds. with topical application. Silymarin is applied topically for ten minutes at concentration 7mg/ml.
干预措施: Gingival Depigmentation with Microneedling and Silymarin Application (Procedure)
结局指标
主要结局
Gingival Pigmentation Recurrence
时间窗: From the enrollment till 6 months
Visual assessment will be the way to measure how the gingiva is depigmented through DOPI score from 1 ( no pigments ) to 4 ( maximum pigments )
次要结局
- post-operative pain(pain will recoreded at 1,3,5,7days after the treatment ( from intervention till 1 week ))
研究者
Tarek Taha Amin Abdeltawab
Operator
Fayoum University