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Completed

NCT Number: NCT03719274

Vitamin C Depigmenattion Versus Conventional Technique

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

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

vitamin c depigementation

Dietary Supplement

locally injected vitamin c depigementation

Primary outcomes

  1. gingival color change

    Time frame: 6 months

    the degree of gingival color is determined by 2 different color indices

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Oct 25, 2018
Registry last updated
Oct 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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