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Microneedling With Vitamin C Versus Injectable Vitamin C for Depigmentation in Gingival Melanin Hyperpigmentation

Primary Purpose

Gingival Pigmentation

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Microneedling will be done with application of topical vitamin C paste for depigmentation
Vitamin C injection
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingival Pigmentation

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients exhibiting physiological melanin hyperpigmentation in the anterior region of the upper or lower gingiva. Patients should be free from any systemic diseases according to modified Cornell Medical index. Non- smokers. Exclusion Criteria: Patients with periodontal disease. Patients with endocrine disorders causing hyperpigmentation or drug induced gingival pigmentation. Pregnant or lactating females. Patients with known hypersensitivity to vitamin C.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Intervention Group

    Control Group

    Arm Description

    Microneedling will be done with application of topical vitamin C paste for depigmentation

    Gingival depigmentation will be done by vitamin C injection only.

    Outcomes

    Primary Outcome Measures

    Surface area of pigmentation
    an intraoral picture (labial view) showing the hyperpigmented gingiva of the patient, is uploaded to ImageJ software. the length of central incisor is measured intra orally from the incisal edge to the CEJ and used as a reference to adjust the image scale of the software. On ImageJ software, a line is drawn surrounding the pigmented area and the software automatically measures the surface area of the selected pigmented area
    Surface area of pigmentation
    an intraoral picture (labial view) showing the hyperpigmented gingiva of the patient, is uploaded to ImageJ software. the length of central incisor is measured intra orally from the incisal edge to the CEJ and used as a reference to adjust the image scale of the software. On ImageJ software, a line is drawn surrounding the pigmented area and the software automatically measures the surface area of the selected pigmented area

    Secondary Outcome Measures

    Dummett-Gupta Oral Pigmentation Index
    The degree of gingival pigmentation is scored as 0, pink tissue [no clinical pigmentation]; 1 = mild light brown tissue [mild clinical pigmentation]; 2, medium brown or mixed brown and pink tissue [moderate clinical pigmentation]; or 3, deep brown/blue-black tissue [heavy clinical pigmentation].
    Gingival thickness
    Using a standard no. 35 endodontic finger spreader with a rubber stop. The gingival biotype will be considered thin if the measurement is ≤1.0 mm and thick if it measured >1.0 mm.
    Pain (patient related outcome)
    Using Visual analogue score questionnaire, score is from 0-10, where 0 is the minimum value representing no pain and 10 is the maximum value representing the highest level of pain felt.
    Pain (patient related outcome)
    The rate of analgesic consumption will be recorded.
    Patient Satisfaction
    Using questionnaire to score the degree of patient satisfaction with the cosmetic results of the procedure. It will be documented depending on the patient's opinion, measured on a five-point scale 0: Very dissatisfied 1: Dissatisfied 2: Neither satisfied nor dissatisfied 3: Satisfied 4: Very satisfied

    Full Information

    First Posted
    March 5, 2023
    Last Updated
    March 15, 2023
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05786885
    Brief Title
    Microneedling With Vitamin C Versus Injectable Vitamin C for Depigmentation in Gingival Melanin Hyperpigmentation
    Official Title
    Microneedling With Vitamin C Versus Injectable Vitamin C for Depigmentation in Physiological Gingival Melanin Hyperpigmentation: A Randomized Controlled Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 2023 (Anticipated)
    Primary Completion Date
    July 2023 (Anticipated)
    Study Completion Date
    July 2024 (Anticipated)

    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

    5. Study Description

    Brief Summary
    The study is a randomized controlled clinical trial comparing the use of microneedling with vitamin C against injecting vitamin C for depigmentation in physiological gingival melanin hyperpigmentation in a group of patients attending the outpatient clinic of the department of Oral Medicine and Periodontology-Cairo University.
    Detailed Description
    Melanin hyperpigmentation has been linked to a number of etiological and pathological causes, including smoking, heavy metal toxicity, heredity, endocrine disorders, UV exposure, inflammation, benign and malignant lesions, and intentional cultural tattooing. In order to determine whether the reason is physiological or pathological, a thorough medical history of the patient is essential. With the introduction of gingival depigmentation as a periodontal surgical procedure, the hyperpigmented gingival tissues are removed utilizing a variety of surgical treatment methods, such as scalpel excision, bur abrasion, free gingival grafts, ADMA, lasers, cryosurgery, electro surgery. The surgical approaches, albeit the most popular, are associated by anxiety, bleeding, a significant postoperative wound, and recurrence. Those methods could also have negative consequences include chemical burns, delayed healing, extreme pain and suffering, bone loss, and trouble controlling the depth of de-epithelization. Vitamin C has been developed as a treatment for melanin pigmentation, due to its suppression of tyrosine activity, which directly downregulates dopaquinone synthesis, a precursor in the manufacture of melanin, as well as its epigenetic inhibitory effect on genes involved in melanocyte function. In vivo studies showed its impact on melanocyte function and quantitative productivity as well as how it affected melanocyte and keratinocyte cell-to-cell contact in a dose-dependent manner. Local application of vitamin C to the gingiva as an adjunct to surgical depigmentation techniques has been shown in several case studies to depigment the gingiva or delay the repigmentation of the gingiva, supporting the possibility of using Vitamin C alone as a treatment modality for melanin-related gingival hyperpigmentation. In a study comparing the use of vitamin C injections versus the conventional surgical method, a statistical significant difference between both groups was found at one month regarding the mean values of changes in pigmentation index. Needle-based delivery systems are designed to deliver medications by rupturing the skin or mucosal barrier, making the medication easily accessible to the targeted tissues. The collagen induction therapy method known as microneedling approach involves puncturing the skin repeatedly. Microneedling has been widely used in dermatology recently since it is a method that is efficient, straightforward, affordable, well-tolerated, and advantageous from both a cosmetic and therapeutic standpoint. Instead of cutting through the cells, the used microneedles create microconduits that increase the skin's permeability and blood flow into the epidermis. This procedure makes it easier for topical drugs to cross the stratum corneum layer. Additionally, growth factors that support the regeneration of collagen and elastin are created. The microneedling principle is suggested to be used in the treatment of gingival hyperpigmentation, compared to the currently employed techniques such as scalpel surgery, laser ablation, bur abrasion, and electrocautery which frequently result in complications, microneedling could be a promising minimally invasive, straightforward, painless, and cost-effective treatment modality for gingival depigmentation. Subsequent randomized controlled clinical trials are required to validate the findings for the case report that mentioned the use of Dermapen with vitamin C topical paste as a novel technique for gingival depigmentation. Vitamin C has the ability to suppress tyrosine activity, which directly downregulates dopaquinone synthesis, a precursor in the manufacture of melanin, as well as its epigenetic inhibitory effect on genes involved in melanocyte function. Thus, Vitamin C injections can be used as a minimal invasive technique for physiological gingival melanin hyperpigmentation. Microneedling has been widely used in dermatology due to its ability to create microconduits that increase the skin's permeability and blood flow into the epidermis. Thus, Dermapen together with vitamin C topical paste has been used as a novel technique for gingival depigmentation in a case report.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gingival Pigmentation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    22 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention Group
    Arm Type
    Experimental
    Arm Description
    Microneedling will be done with application of topical vitamin C paste for depigmentation
    Arm Title
    Control Group
    Arm Type
    Active Comparator
    Arm Description
    Gingival depigmentation will be done by vitamin C injection only.
    Intervention Type
    Procedure
    Intervention Name(s)
    Microneedling will be done with application of topical vitamin C paste for depigmentation
    Intervention Description
    A Dermapen device will be used to microneedle the gingival tissue (model M8) with 24 microneedles arranged in rows, which is adjusted with 1.5 mm depth at the 6th mode speed of 700 cycles/min. It will be used in intermittent motion on the affected area for 30-40 seconds / tooth. Once bleeding points are observed on all areas of the pigmented gingiva, it will be irrigated using saline solution and dried using sterile gauze. Topical vitamin C powder (1000 mg/ml) will be mixed with saline, and the resultant slurry mix will then be applied to the gingiva for 10 minutes.
    Intervention Type
    Procedure
    Intervention Name(s)
    Vitamin C injection
    Intervention Description
    1-1.5 ml Vitamin C will be injected into the gingiva, using an insulin syringe, once weekly, for 3 weeks. All the injection procedures will be performed by the same operator. The treated area will be left without dressing in both groups.
    Primary Outcome Measure Information:
    Title
    Surface area of pigmentation
    Description
    an intraoral picture (labial view) showing the hyperpigmented gingiva of the patient, is uploaded to ImageJ software. the length of central incisor is measured intra orally from the incisal edge to the CEJ and used as a reference to adjust the image scale of the software. On ImageJ software, a line is drawn surrounding the pigmented area and the software automatically measures the surface area of the selected pigmented area
    Time Frame
    Measured at baseline
    Title
    Surface area of pigmentation
    Description
    an intraoral picture (labial view) showing the hyperpigmented gingiva of the patient, is uploaded to ImageJ software. the length of central incisor is measured intra orally from the incisal edge to the CEJ and used as a reference to adjust the image scale of the software. On ImageJ software, a line is drawn surrounding the pigmented area and the software automatically measures the surface area of the selected pigmented area
    Time Frame
    Measured at 3 months after the intervention.
    Secondary Outcome Measure Information:
    Title
    Dummett-Gupta Oral Pigmentation Index
    Description
    The degree of gingival pigmentation is scored as 0, pink tissue [no clinical pigmentation]; 1 = mild light brown tissue [mild clinical pigmentation]; 2, medium brown or mixed brown and pink tissue [moderate clinical pigmentation]; or 3, deep brown/blue-black tissue [heavy clinical pigmentation].
    Time Frame
    Measured at baseline and 3 months after the intervention.
    Title
    Gingival thickness
    Description
    Using a standard no. 35 endodontic finger spreader with a rubber stop. The gingival biotype will be considered thin if the measurement is ≤1.0 mm and thick if it measured >1.0 mm.
    Time Frame
    Measured at baseline and 3 months after the intervention.
    Title
    Pain (patient related outcome)
    Description
    Using Visual analogue score questionnaire, score is from 0-10, where 0 is the minimum value representing no pain and 10 is the maximum value representing the highest level of pain felt.
    Time Frame
    Recorded daily, starting from the same day after the intervention, up to 7 days after the intervention.
    Title
    Pain (patient related outcome)
    Description
    The rate of analgesic consumption will be recorded.
    Time Frame
    7 days after the intervention.
    Title
    Patient Satisfaction
    Description
    Using questionnaire to score the degree of patient satisfaction with the cosmetic results of the procedure. It will be documented depending on the patient's opinion, measured on a five-point scale 0: Very dissatisfied 1: Dissatisfied 2: Neither satisfied nor dissatisfied 3: Satisfied 4: Very satisfied
    Time Frame
    Measured 3 months after the intervention.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients exhibiting physiological melanin hyperpigmentation in the anterior region of the upper or lower gingiva. Patients should be free from any systemic diseases according to modified Cornell Medical index. Non- smokers. Exclusion Criteria: Patients with periodontal disease. Patients with endocrine disorders causing hyperpigmentation or drug induced gingival pigmentation. Pregnant or lactating females. Patients with known hypersensitivity to vitamin C.

    12. IPD Sharing Statement

    Learn more about this trial

    Microneedling With Vitamin C Versus Injectable Vitamin C for Depigmentation in Gingival Melanin Hyperpigmentation

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