Gingival PigmentationNCT05786885
Microneedling With Vitamin C Versus Injectable Vitamin C for Depigmentation in Gingival Melanin Hyperpigmentation
A study testing Microneedling will be done with application of topical vitamin C paste for depigmentation and Vitamin C injection in people with Gingival Pigmentation, run by Cairo University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Gingival Pigmentation
- What is being tested?
- Microneedling will be done with application of topical vitamin C paste for depigmentation and Vitamin C injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- Apr 2023to Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Microneedling With Vitamin C Versus Injectable Vitamin C for Depigmentation in Physiological Gingival Melanin Hyperpigmentation: A Randomized Controlled Clinical Trial
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.
Read the 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.
- Conditions
- Gingival Pigmentation
- Being tested
- Microneedling will be done with application of topical vitamin C paste for depigmentation, Vitamin C injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microneedling will be done with application of topical vitamin C paste for depigmentationProcedure or surgery
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.
Vitamin C injectionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Microneedling will be done with application of topical vitamin C paste for depigmentation Receives: Procedure: Microneedling will be done with application of topical vitamin C paste for depigmentation |
| Control Group | Active comparator | Gingival depigmentation will be done by vitamin C injection only. Receives: Procedure: Vitamin C injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Measured at baseline
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
Measured: Measured at 3 months after the intervention.
Secondary outcomes (5)
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].
Measured: Measured at baseline and 3 months after the intervention.
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.
Measured: Measured at baseline and 3 months after the intervention.
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.
Measured: Recorded daily, starting from the same day after the intervention, up to 7 days after the intervention.
Pain (patient related outcome)
The rate of analgesic consumption will be recorded.
Measured: 7 days after the intervention.
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
Measured: Measured 3 months after the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2023
- Study startApr 2023 (estimated)
- Primary completionJul 2023 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival PigmentationStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Gamil, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05786885
- Sponsor's protocol ID
- 22091990
- Status last verified
- Mar 2023
- First submitted
- 5 Mar 2023
- Last updated
- 28 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microneedling With Vitamin C Versus Injectable Vitamin C for Depigmentation in Physiological Gingival Melanin Hyperpigmentation: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05786885
- Acronym / sponsor ID
- 22091990
- Conditions
- Gingival Pigmentation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Apr 2023 (estimated)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 28 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Procedure: Microneedling will be done with application of topical vitamin C paste for depigmentationMicroneedling will be done with application of topical vitamin C paste for depigmentation |
| Control Group | Active comparator | Procedure: Vitamin C injectionGingival depigmentation will be done by vitamin C injection only. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microneedling will be done with application of topical vitamin C paste for depigmentationA 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. | Procedure or surgery | Intervention Group |
| Vitamin C injection1-1.5 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. | Procedure or surgery | Control Group |
Primary outcome
Surface area of pigmentation
Time frame: Measured at baseline
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
Time frame: Measured at 3 months after the intervention.
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
5 secondary outcomes
Dummett-Gupta Oral Pigmentation Index
Time frame: Measured at baseline and 3 months after the intervention.
Gingival thickness
Time frame: Measured at baseline and 3 months after the intervention.
Pain (patient related outcome)
Time frame: Recorded daily, starting from the same day after the intervention, up to 7 days after the intervention.
Pain (patient related outcome)
Time frame: 7 days after the intervention.
Patient Satisfaction
Time frame: Measured 3 months after the intervention.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2023.
Related trials for Gingival Pigmentation
Not yet recruiting
Gingival Depigmentation Using a 940 nm Diode Laser Versus Ceramic Bur
Physiologic Gingival Melanin Pigmentation
Enrolling by invitationPhase 3
Evaluation of the Efficacy of Topical Application of Liquid Nitrogen and Ascorbic Acid in Treatment of Gingival Pigmentation
Gingival Pigmentation, Gingiival Hyperpigmentation
Not yet recruiting
Influence of Adjunctive Acids Use on Esthetic Outcomes of Gingival Melanin Depigmentation: A Periodontal-Operative Pilot Randomized Clinical Trial
Gingival Pigmentation
Recruiting
Effect of Co-enzyme Q10 and Vitamin C Alone or in Combination After a Surgical Gingival Depigmentation
Depigmentation Treatment, Depigmentation
RecruitingPhase 2
Gingival Hyperpigmentation Treatment
Gingival Pigmentation, Depigmentation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Microneedling will be done with application of topical vitamin C paste for depigmentation and Vitamin C injection in people with Gingival Pigmentation, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surface area of pigmentation (time frame: Measured at baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2023.