Vitamin C Depigmenattion Versus Conventional Technique

Melanin Hyperpigmentation Clinical Trial

Official title:

Minimally Invasive Non-surgical Vitamin C Injection Versus the Conventional Surgical Depigmentation in Treatment of Gingival Hyperpigmentation of the Anterior Esthetic Zone: Prospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03719274
• Other study ID #: 1237
• Status: Completed
• Phase: N/A
• Start date: April 2016
• Est. completion date: October 2018

Study information

• Verified date: October 2018
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Although physiologic gingival hyperpigmentation is not a pathologic condition, it is considered one of the main esthetic problems in dentistry. It was found that the attached gingiva is the most frequently pigmented intraoral tissues followed by the papillary gingiva and the alveolar mucosa

Description:

In addition to all of the previously mentioned actions of vitamin C, it was found to be involved in depigmentation due to several factors that not only depend on its direct effect on melanin and melanocytes but also due to the overall effect on the applied tissues. Melanin is one of the main reservoir for ROS, copper and calcium in the tissue cells . Once vitamin C is introduced to the target tissue, it binds efficiently to melanin due to the ROS, calcium and copper content which causes intracellular deficiency of these items and the inability of the cells to produce melanin. Calcium deficiency causes failure of melanocytes to perform cellular adhesion to keratinocytes as calcium is essential to form cadherins . Adhesion to keratinocytes is important stimulator to melanocytes in order to produce melanin, format dendrites and transfer the produced melanin to neighboring cells . Shortage of the intercellular copper limits the formation of tyrosin, tyrosinase enzyme and peroxidase enzyme which in turn stops the melanin production .

Therefore, the aim of the present study is to compare the clinical efficiency of the non-surgical intraepidermal injection of vitamin C in comparison to the gold standard surgical technique (scalpel technique) for gingival depigmentation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• aged 18-50 y

• medically free;

• physiologic gingival hyperpigmentation related to esthetic region were selected.

Exclusion Criteria:

All the reasons that could provoke an inflammatory reaction were excluded such as:

• systemic diseases (especially auto-immune diseases and chemotherapy uptake);

• pregnant and lactating mothers;

• usage of chlorhexidine or povidone iodine;

• Local causes (smoking and periodontitis).

Related Conditions & MeSH terms

• Hyperpigmentation
• Melanin Hyperpigmentation
• Melanosis

Intervention

Dietary Supplement:
• vitamin c depigementation
locally injected vitamin c depigementation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	gingival color change	the degree of gingival color is determined by 2 different color indices	6 months