Microneedling With Vitamin C Versus Injectable Vitamin C for Depigmentation in Gingival Melanin Hyperpigmentation

Gingival Pigmentation Clinical Trial

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

Status Not yet recruiting

Clinical Trial Summary

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.

Clinical Trial Description

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.

Needle-based delivery systems are designed to deliver medications by rupturing the skin or mucosal barrier, making the medication easily accessible to the targeted tissues. The collagen induction therapy method known as microneedling approach involves puncturing the skin repeatedly. Microneedling has been widely used in dermatology recently since it is a method that is efficient, straightforward, affordable, well-tolerated, and advantageous from both a cosmetic and therapeutic standpoint.

Instead of cutting through the cells, the used microneedles create microconduits that increase the skin's permeability and blood flow into the epidermis. This procedure makes it easier for topical drugs to cross the stratum corneum layer. Additionally, growth factors that support the regeneration of collagen and elastin are created.

The microneedling principle is suggested to be used in the treatment of gingival hyperpigmentation, compared to the currently employed techniques such as scalpel surgery, laser ablation, bur abrasion, and electrocautery which frequently result in complications, microneedling could be a promising minimally invasive, straightforward, painless, and cost-effective treatment modality for gingival depigmentation. Subsequent randomized controlled clinical trials are required to validate the findings for the case report that mentioned the use of Dermapen with vitamin C topical paste as a novel technique for gingival depigmentation.

Vitamin C has the ability to suppress 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. Thus, Vitamin C injections can be used as a minimal invasive technique for physiological gingival melanin hyperpigmentation.

Microneedling has been widely used in dermatology due to its ability to create microconduits that increase the skin's permeability and blood flow into the epidermis. Thus, Dermapen together with vitamin C topical paste has been used as a novel technique for gingival depigmentation in a case report. ;

Related Conditions & MeSH terms

• Gingival Pigmentation
• Hyperpigmentation
• Hypopigmentation

• NCT number: NCT05786885
• Study type: Interventional
• Source: Cairo University
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2023
• Completion date: July 2024