Gingival HyperpigmentationVitC-DePgNCT07513727
Vitamin C for Gingival Depigmentation
A study testing Vitamin C mesotherapy and Microneedling technique in people with Gingival Hyperpigmentation and Gingival Melanin Pigmentation, run by Al-Azhar University at 1 site in Egypt.
Trial summary
The purpose of this study is to evaluate the clinical and histopathological efficacy of topical vitamin C applications using three modalities (topical gel, microneedling , and mesotherapy) in gingival depigmentation. Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Gingival Hyperpigmentation, Gingival Melanin Pigmentation
- What is being tested?
- Vitamin C mesotherapy and Microneedling technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 29 Jul 2025to 1 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 1- Both genders aged from 20-35 years. 2- Patients clinically diagnosed with physiologic gingival melanin pigmentation in the maxillary and mandibular keratinized gingiva.
- 3- Patients complaining of compromised esthetics. 4- Patients should be systemically free any disease as verified by a medical history diagnostic sheet or via health questionnaire
Who cannot join
- 1- Patient clinically diagnosed with periodontitis and / or manifest poor oral hygiene with high plaque and gingival indices 2- Pregnant or lactating females. 3- Patients with clinical diagnosed lesion in the area of interest primarily the gingivae encompassing the maxillary /mandibular anterior teeth e.g. pigmented lesion of intestinal polyposis syndrome, McCune-Albright syndrome and fibro-osseous lesions as florid osseous dysplasia.
- 4- Patient with previous treatment of gingival hyperpigmentation. 5- Patients with history of being allergic to the vitamin C. 6- Patients with any systemic disease ( e.g. Addison disease ) or drugs consumed that may cause clinical gingival hyperpigmentation 7- Patients who are active or previous smokers.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Al-Azhar University Faculty of Dentistry ( Girls )
Cairo, Cario Governorate, 11651
khawlah Q alkhalidi, BDS, MSc, 00201556811594, khawlahalkhalidi555@gmail.com
About this study
Official title: Clinical and Histological Evaluation of Topical Vitamin C Application Using Three Modalities in Gingival Depigmentation
The purpose of this study is to evaluate the clinical and histopathological efficacy of topical vitamin C applications using three modalities (topical gel, microneedling , and mesotherapy) in gingival depigmentation. Assessment includes clinical evaluation, CIELAB analysis via DOPI, and histopathological examination (Fontana-Masson staining).
- Being tested
- Topical Vitamin C ( control Arm), Vitamin C mesotherapy, Microneedling technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical Vitamin C ( control Arm)Drug
Topical application of L-Ascorbic Acid gel (1000 mg in 5 ml distilled water with CMC and PEG), applied once daily on gingival hyperpigmented areas for 1 month.
Vitamin C mesotherapyProcedure or surgery
vitamin C mesotherapy was administered by delivering intra-mucosal microinjections of L-ascorbic acid into pigmented gingival tissues at the epithelium-connective tissue junction, providing targeted delivery to melanocyte-rich layers. . The treatment will be repeated 3 times with 1 week .
Microneedling techniqueProcedure or surgery
Gingival microneedling was performed using a Derma Pen A6 (12-needle row), with penetration depth adjusted to gingival thickness at 700 cycles/min (mode 6). Each gingival side was treated 30-40 seconds per tooth until bleeding points appeared.
| Study group | Role | What they receive |
|---|---|---|
| Topical Vitamin C | Active comparator | Patients will be instructed to apply ( L- Ascorbic acid 1000 mg) containing gel in 5 ml distilled water, Polyethylene Glyco (PEG), Potassium Sorbate, in addition to Sodium Carboxymethyl Cellulose (CMC)] and Carbomer once daily for 1 months Receives: Drug: Topical Vitamin C ( control Arm); Procedure: Vitamin C mesotherapy; Procedure: Microneedling technique |
| microneedling with topical Vitamin C gel | Experimental | Microneedling was performed on the gingival tissue using a dermal pin device until the appearance of pinpoint bleeding, indicating adequate micro-injury to stimulate tissue remodeling. The treated area was subsequently irrigated with normal saline and gently dried with sterile gauze. This procedure was repeated after a two-week interval to enhance the clinical effect. Receives: Drug: Topical Vitamin C ( control Arm); Procedure: Vitamin C mesotherapy; Procedure: Microneedling technique |
| Vitamin C Mesotherapy | Experimental | vitamin C mesotherapy was administered by delivering intra-mucosal microinjections of L-ascorbic acid into pigmented gingival tissues at the epithelium-connective tissue junction, providing targeted delivery to melanocyte-rich layers. . The treatment will be repeated 3 times with 1 week . Receives: Drug: Topical Vitamin C ( control Arm); Procedure: Vitamin C mesotherapy; Procedure: Microneedling technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dummet oral Pigmentation Index (DOPI).
Evaluating the degree of melanin pigmentation at baseline and follow-up visits. Scoring was conducted by calibrated examiners under standardized lighting conditions to ensure reproducibility of clinical measurements.
Measured: baseline to 3 months
Secondary outcomes (2)
Melanin area fraction
Quantitative assessment of gingival melanin pigmentation was performed by histopathological analysis of gingival tissue specimens stained with Fontana-Masson, and the mean melanin-containing area fraction was calculated at baseline and follow-up to evaluate pigmentation changes according to established morphometric methods used in clinical histopathological studies.
Measured: baseline to 3 months
Patient satisfaction
To score degree of pain experienced during and after treatment and the degree of patient satisfaction with the cosmetic result of the procedure was used.2 weeks
Measured: 2 weeks , 1 month , and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start29 Jul 2025
- Primary completion1 May 2026 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival HyperpigmentationStudies of the same condition, open and under way.
- 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
- Model description
- "Participants will be randomly assigned to one of three intervention groups: Topical Vitamin C gel application, Vitamin C via mesotherapy injection, Microneedling with Vitamin C. Each intervention will be applied according to standardized protocols, and clinical as well as histopathological assessments will be conducted to evaluate changes in gingival pigmentation over a 3-month period."
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khawlah Qaism Ahmed Alkhalidi, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07513727
- Sponsor's protocol ID
- K.Al.K-2025-01
- Other IDs
- OMPDR-105-1t
- Acronym
- VitC-DePg
- Status last verified
- Sep 2025
- First submitted
- 31 Mar 2026
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Histological Evaluation of Topical Vitamin C Application Using Three Modalities in Gingival Depigmentation
- ClinicalTrials.gov ID
- NCT07513727
- Acronym / sponsor ID
- VitC-DePg / K.Al.K-2025-01
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 29 Jul 2025 (actual)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 7 Apr 2026 (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 purpose of this study is to evaluate the clinical and histopathological efficacy of topical vitamin C applications using three modalities (topical gel, microneedling , and mesotherapy) in gingival depigmentation. Assessment includes clinical evaluation, CIELAB analysis via DOPI, and histopathological examination (Fontana-Masson staining).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- "Participants will be randomly assigned to one of three intervention groups: Topical Vitamin C gel application, Vitamin C via mesotherapy injection, Microneedling with Vitamin C. Each intervention will be applied according to standardized protocols, and clinical as well as histopathological assessments will be conducted to evaluate changes in gingival pigmentation over a 3-month period."
| Arm | Type | Receives |
|---|---|---|
| Topical Vitamin C | Active comparator | Drug: Topical Vitamin C ( control Arm), Procedure: Vitamin C mesotherapy, Procedure: Microneedling techniquePatients will be instructed to apply ( L- Ascorbic acid 1000 mg) containing gel in 5 ml distilled water, Polyethylene Glyco (PEG), Potassium Sorbate, in addition to Sodium Carboxymethyl Cellulose (CMC)] and Carbomer once daily for 1 months |
| microneedling with topical Vitamin C gel | Experimental | Drug: Topical Vitamin C ( control Arm), Procedure: Vitamin C mesotherapy, Procedure: Microneedling techniqueMicroneedling was performed on the gingival tissue using a dermal pin device until the appearance of pinpoint bleeding, indicating adequate micro-injury to stimulate tissue remodeling. The treated area was subsequently irrigated with normal saline and gently dried with sterile gauze. This procedure was repeated after a two-week interval to enhance the clinical effect. |
| Vitamin C Mesotherapy | Experimental | Drug: Topical Vitamin C ( control Arm), Procedure: Vitamin C mesotherapy, Procedure: Microneedling techniquevitamin C mesotherapy was administered by delivering intra-mucosal microinjections of L-ascorbic acid into pigmented gingival tissues at the epithelium-connective tissue junction, providing targeted delivery to melanocyte-rich layers. . The treatment will be repeated 3 times with 1 week . |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 1- Both genders aged from 20-35 years. 2- Patients clinically diagnosed with physiologic gingival melanin pigmentation in the maxillary and mandibular keratinized gingiva.
- 3- Patients complaining of compromised esthetics. 4- Patients should be systemically free any disease as verified by a medical history diagnostic sheet or via health questionnaire
Key exclusion criteria (2 listed)
- 1- Patient clinically diagnosed with periodontitis and / or manifest poor oral hygiene with high plaque and gingival indices 2- Pregnant or lactating females. 3- Patients with clinical diagnosed lesion in the area of interest primarily the gingivae encompassing the maxillary /mandibular anterior teeth e.g. pigmented lesion of intestinal polyposis syndrome, McCune-Albright syndrome and fibro-osseous lesions as florid osseous dysplasia.
- 4- Patient with previous treatment of gingival hyperpigmentation. 5- Patients with history of being allergic to the vitamin C. 6- Patients with any systemic disease ( e.g. Addison disease ) or drugs consumed that may cause clinical gingival hyperpigmentation 7- Patients who are active or previous smokers.
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 |
|---|---|---|
| Topical Vitamin C ( control Arm)Topical application of L-Ascorbic Acid gel (1000 mg in 5 ml distilled water with CMC and PEG), applied once daily on gingival hyperpigmented areas for 1 month. | Drug | Topical Vitamin C, Vitamin C Mesotherapy, microneedling with topical Vitamin C gel |
| Vitamin C mesotherapyvitamin C mesotherapy was administered by delivering intra-mucosal microinjections of L-ascorbic acid into pigmented gingival tissues at the epithelium-connective tissue junction, providing targeted delivery to melanocyte-rich layers. . The treatment will be repeated 3 times with 1 week . | Procedure or surgery | Topical Vitamin C, Vitamin C Mesotherapy, microneedling with topical Vitamin C gel |
| Microneedling techniqueGingival microneedling was performed using a Derma Pen A6 (12-needle row), with penetration depth adjusted to gingival thickness at 700 cycles/min (mode 6). Each gingival side was treated 30-40 seconds per tooth until bleeding points appeared. | Procedure or surgery | Topical Vitamin C, Vitamin C Mesotherapy, microneedling with topical Vitamin C gel |
Primary outcome
Dummet oral Pigmentation Index (DOPI).
Time frame: baseline to 3 months
Evaluating the degree of melanin pigmentation at baseline and follow-up visits. Scoring was conducted by calibrated examiners under standardized lighting conditions to ensure reproducibility of clinical measurements.
2 secondary outcomes
Melanin area fraction
Time frame: baseline to 3 months
Patient satisfaction
Time frame: 2 weeks , 1 month , and 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin C mesotherapy and Microneedling technique in people with Gingival Hyperpigmentation and Gingival Melanin Pigmentation, run by Al-Azhar University at 1 site in Egypt.
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 2 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact khawlah Q al-khalidi, BDS, MSc (00201556811594, khawlahalkhalidi555@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dummet oral Pigmentation Index (DOPI). (time frame: baseline to 3 months). 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 7 Apr 2026.