跳至主要内容
临床试验/NCT05786885
NCT05786885尚未招募不适用

Microneedling With Vitamin C Versus Injectable Vitamin C for Depigmentation in Physiological Gingival Melanin Hyperpigmentation: A Randomized Controlled Clinical Trial

Cairo University0 个研究点目标入组 22 人开始时间: 2023年4月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
22
主要终点
Surface area of pigmentation

研究概览

简要总结

The study is a randomized controlled clinical trial comparing the use of microneedling with vitamin C against injecting vitamin C for depigmentation in physiological gingival melanin hyperpigmentation in a group of patients attending the outpatient clinic of the department of Oral Medicine and Periodontology-Cairo University.

详细描述

Melanin hyperpigmentation has been linked to a number of etiological and pathological causes, including smoking, heavy metal toxicity, heredity, endocrine disorders, UV exposure, inflammation, benign and malignant lesions, and intentional cultural tattooing. In order to determine whether the reason is physiological or pathological, a thorough medical history of the patient is essential.

With the introduction of gingival depigmentation as a periodontal surgical procedure, the hyperpigmented gingival tissues are removed utilizing a variety of surgical treatment methods, such as scalpel excision, bur abrasion, free gingival grafts, ADMA, lasers, cryosurgery, electro surgery.

The surgical approaches, albeit the most popular, are associated by anxiety, bleeding, a significant postoperative wound, and recurrence. Those methods could also have negative consequences include chemical burns, delayed healing, extreme pain and suffering, bone loss, and trouble controlling the depth of de-epithelization.

Vitamin C has been developed as a treatment for melanin pigmentation, due to its suppression of tyrosine activity, which directly downregulates dopaquinone synthesis, a precursor in the manufacture of melanin, as well as its epigenetic inhibitory effect on genes involved in melanocyte function. In vivo studies showed its impact on melanocyte function and quantitative productivity as well as how it affected melanocyte and keratinocyte cell-to-cell contact in a dose-dependent manner.

Local application of vitamin C to the gingiva as an adjunct to surgical depigmentation techniques has been shown in several case studies to depigment the gingiva or delay the repigmentation of the gingiva, supporting the possibility of using Vitamin C alone as a treatment modality for melanin-related gingival hyperpigmentation. In a study comparing the use of vitamin C injections versus the conventional surgical method, a statistical significant difference between both groups was found at one month regarding the mean values of changes in pigmentation index.

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
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients exhibiting physiological melanin hyperpigmentation in the anterior region of the upper or lower gingiva.
  • Patients should be free from any systemic diseases according to modified Cornell Medical index.
  • Non- smokers.

排除标准

  • Patients with periodontal disease.
  • Patients with endocrine disorders causing hyperpigmentation or drug induced gingival pigmentation.
  • Pregnant or lactating females.
  • Patients with known hypersensitivity to vitamin C.

结局指标

主要结局

Surface area of pigmentation

时间窗: Measured at 3 months after the intervention.

an intraoral picture (labial view) showing the hyperpigmented gingiva of the patient, is uploaded to ImageJ software. the length of central incisor is measured intra orally from the incisal edge to the CEJ and used as a reference to adjust the image scale of the software. On ImageJ software, a line is drawn surrounding the pigmented area and the software automatically measures the surface area of the selected pigmented area

次要结局

  • Patient Satisfaction(Measured 3 months after the intervention.)
  • Pain (patient related outcome)(7 days after the intervention.)
  • Dummett-Gupta Oral Pigmentation Index(Measured at baseline and 3 months after the intervention.)
  • Gingival thickness(Measured at baseline and 3 months after the intervention.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mostafa Gamil

Principal investigator

Cairo University

相似试验