Vitamin C Depigmenattion Versus Conventional Technique

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

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

Study Overview

• Status: Completed
• Conditions: Melanin Hyperpigmentation
• Intervention / Treatment: Dietary supplement: vitamin c depigementation

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 46 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: non-surgical vitamin c depigmentation; locally injected vitamin c is used to depigment the hyperpigmented gingival tissues	Dietary supplement: vitamin c depigementation; locally injected vitamin c depigementation
Active Comparator: surgical depigmentation; the conventional scalpel surgical technique is used to depigment the hyperpigmented gingival tissues	Dietary supplement: vitamin c depigementation; locally injected vitamin c depigementation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
gingival color change	the degree of gingival color is determined by 2 different color indices	6 months

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Director: nermin yussif, MSA University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2016
• Primary Completion (Actual): June 1, 2018
• Study Completion (Actual): October 1, 2018

Study Registration Dates

• First Submitted: October 22, 2018
• First Submitted That Met QC Criteria: October 23, 2018
• First Posted (Actual): October 25, 2018

Study Record Updates

• Last Update Posted (Actual): October 25, 2018
• Last Update Submitted That Met QC Criteria: October 23, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Pigmentation Disorders; Hyperpigmentation; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Micronutrients; Vitamins; Antioxidants; Ascorbic Acid
• Other Study ID Numbers: 1237

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No