Vitamin C Depigmenattion Versus Conventional Technique

NCT ID: NCT03719274

Last Updated: 2018-10-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2018-10-31

Brief 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

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.

Conditions

Melanin Hyperpigmentation

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

non-surgical vitamin c depigmentation

locally injected vitamin c is used to depigment the hyperpigmented gingival tissues

Group Type: EXPERIMENTAL

vitamin c depigementation

Intervention Type: DIETARY_SUPPLEMENT

locally injected vitamin c depigementation

surgical depigmentation

the conventional scalpel surgical technique is used to depigment the hyperpigmented gingival tissues

Group Type: ACTIVE_COMPARATOR

vitamin c depigementation

Intervention Type: DIETARY_SUPPLEMENT

locally injected vitamin c depigementation

Interventions

vitamin c depigementation

locally injected vitamin c depigementation

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

nermin mohammed ahmed yussif

assistant lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

nermin yussif

Role: STUDY_DIRECTOR

msa university

Other Identifiers

1237

Identifier Type: -

Identifier Source: org_study_id