Back to resultsVitamin C Depigmenattion Versus Conventional Technique
Primary Purpose
Melanin Hyperpigmentation
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
vitamin c depigementation
Sponsored by
About this trial
This is an interventional treatment trial for Melanin Hyperpigmentation
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).
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
non-surgical vitamin c depigmentation
surgical depigmentation
Arm Description
locally injected vitamin c is used to depigment the hyperpigmented gingival tissues
the conventional scalpel surgical technique is used to depigment the hyperpigmented gingival tissues
Outcomes
Primary Outcome Measures
gingival color change
the degree of gingival color is determined by 2 different color indices
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03719274
Brief Title
Vitamin C Depigmenattion Versus Conventional Technique
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
April 2016 (Actual)
Primary Completion Date
June 2018 (Actual)
Study Completion Date
October 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanin Hyperpigmentation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Non-Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
non-surgical vitamin c depigmentation
Arm Type
Experimental
Arm Description
locally injected vitamin c is used to depigment the hyperpigmented gingival tissues
Arm Title
surgical depigmentation
Arm Type
Active Comparator
Arm Description
the conventional scalpel surgical technique is used to depigment the hyperpigmented gingival tissues
Intervention Type
Dietary Supplement
Intervention Name(s)
vitamin c depigementation
Intervention Description
locally injected vitamin c depigementation
Primary Outcome Measure Information:
Title
gingival color change
Description
the degree of gingival color is determined by 2 different color indices
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
nermin yussif
Organizational Affiliation
msa university
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Vitamin C Depigmenattion Versus Conventional Technique
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