Gingival PigmentationPhase 2NCT07595705
Gingival Hyperpigmentation Treatment
A Phase 2 study testing Vitamin c and glutathione and Surgical depigmentation in people with Gingival Pigmentation and Depigmentation, run by Cairo University at 1 site in Egypt.
Trial summary
It is a clinical study conducted to evaluate the effect of vitamin C and Glucathonine injection of pigmented gingival tissue versus surgical removal by scalpel Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gingival Pigmentation, Depigmentation, Vitamin C
- What is being tested?
- Vitamin c and glutathione and Surgical depigmentation
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2025to Oct 2027
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The selection criteria were done according to Gingival pigmentation index is as follows (Dummett and Bolden)10:
- Score0:absence of pigmentation
- Score1:spotsofbrowntoblackcolororpigments
- Score2:browntoblackpatchesbutnotdiffusepigmentation
- Score3:diffuse brown to black pigmentation,marginal,and attached.
- Patients who have Dummett and Bolden index score 1, 2, or 3 will be included in addition to the following criteria:
Show all 10Show fewer
- above 18yrs
- systemically free
- physiologic gingival hyperpigmentation related to esthetic region
- well maintained oral hygiene and willing to undergo minor surgical procedures
Who cannot join
- systemic diseases associated with pathological hyperpigmentation or improper delayed wound healing (uncontrolled diabetes, autoimmune diseases, etc.)
- pregnant and lactating mothers
- usage of chlorhexidine or povidone iodine
- Local causes (smoking)
- periodontal diseases (plaque and non-plaque induced gingivitis or periodontitis)
- non compliant patients
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
Faculty of Dentistry
Al Fayyum, Faiyum Governorate, 63511
Amr E Emaraa, Associate professor
About this study
Official title: Gingival Hyperpigmentation Treatment With Injectable Vitamin C in Conjunction With Glutathione Versus The Conventional Surgical Depigmentation: A Randomized Controlled Clinical Trial
It is a clinical study conducted to evaluate the effect of vitamin C and Glucathonine injection of pigmented gingival tissue versus surgical removal by scalpel
Read the detailed description
Over the last decade, an increasing interest has been observed in esthetic treatments. In fact, The smile is an important aesthetic component of the face and significantly impacts the perception of beauty and psychological well-being. Gingival hyperpigmentation has been an aesthetic problem for many patients, which can definitely affect their psychosocial behavior.
Gingival hyperpigmentation is not a condition and can be defined as " a darker gingival color beyond what is normally expected". Moreover, it can be attributed to multiple external or internal factors. It may be physiological (excessive melanin deposition) or pathological (smoking).
Gingival Depigmentation can be treated by different modalities including chemical and surgical methods. Lately, gingival Depigmentation was carried out by lasers, cryosurgery and radiosurgery.
Additionally, multiple evidence have suggested the use of ascorbic acid (vitamin C) to treat gin- gival pigmentation. It was demonstrated that ascorbic acid is a water-soluble antioxidant and an essential nutrient for collagen biosynthesis. Furthermore, it was proven that it is effective in the elimination of hyperpigmented lesion.
Lately, glutathione has come into focus in aesthetics because of its antimelanogenic (inhibits melanosome transfer from melanocytes to keratinocytes) and antioxidant properties. It aids in skin lightening because it inhibits tyrosinase enzymes. Moreover, the use of vitamin C and glutathione has been well established, as they participate in antioxidant cellular defense systems. The series of oxidation-reduction reactions that allow vitamin C and glutathione to interact each other makes them unique The aim of the current study is to evaluate the efficacy of its rather-epidermal vitamin C in conjunction with glutathione injection compared to the conventional surgical technique in order to manage patients with gingival hyperpigmentation.
- Conditions
- Gingival Pigmentation, Depigmentation, Vitamin C, Glutathione
- Being tested
- Vitamin c and glutathione, Surgical depigmentation
- Keywords
- depigmentation, vit c, glutathione, gingival depigmentation
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin c and glutathioneDrug
Vitamins c and glutathione injection that usually used for cosmetic skin care (whitening)
Surgical depigmentationProcedure or surgery
Removal of gingival pigmentation by scalpel
| Study group | Role | What they receive |
|---|---|---|
| Arm1:(Vit C & glutathione injection) | Experimental | The site of interest will be anesthetized using topical anesthetic agent (lignocaine gel or xylocaine gel). Infiltration anesthesia will be recommended during the first injection visit. Intraepidermal injection of 1-1.5 ml of vitamin C and glutathione will be performed. It will be locally introduced in relation to the keratinized gingival tissues with extension to the whole target region successively using special syringes (50 gauge).
The needle will be introduced parallel to the gingival tissues with the bevel facing upwards. Vitamin C \& glutathione will then be delivered through the attached gingival tissues at the epithelium-connective tissue junction (equivalent to epidermal- dermal junction) till the tissues blanch. Maximum 0.1 ml of injection is recommended for each point with 2-3 mm apart. The same dose will be repeated once per week for maximum 4 visits till no further color improvement gained. Receives: Drug: Vitamin c and glutathione |
| ATM 2: surgical depigmentation | Active comparator | Using a 15c blade an epithelial layer and part of connective tissue will be removed till the pigmentation disappears with ultra care not to expose the bone. The marginal and interdental papillary tissues remain critical regions, fortunately, they are not deeply pigmented. Periodontal dressing is recommended for minimal 7 days postoperative.
Patients will be instructed to avoid the mechanical trauma to the treated sites. Patients will be administering an analgesic (Ibuprofen 400 mg) to be used as needed. Following each injection visit, the patients will be asked to abstain from mechanical oral hygiene procedures in relation to the target region for the day of procedure only. Plain tooth pastes (Colgate toothpaste) with anti- inflammatory mouthwash (Citrolin mouth, Pharco Company, Egypt) were recommended. Receives: Procedure: Surgical depigmentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of gingival pigmentation by Takashi index (Hanioka et al., 2005)
Degree of gingival pigmentation 0: no pigmentation
- solitary unit (s) of pigmentation in papillary gingiva without extension between neighboring solitary units
- formation of continuous ribbon extending from neighboring solitary units)
Measured: baseline: before surgery/injection (day1), after 1 mon ,3 mon ,6 mon and 9 month
Degree of gingival pigmentation by Gingival pigmentation index (Kumar et al., 2013)
Score 0: absence Score 1: spots of brown to black Score 2: brown to black patches but not diffuse Score 3: diffuse brown to black pigmentation
Measured: The color assessment will be evaluated in the daylight and by examining the regular digital photographs which will be taken pre-operative (day of the procedure / day 1), and post-operatively after 1 month and 9 months.
Secondary outcomes (3)
Pain score
VAS scores pain will be divided into ten numerical parts consisting of one cm each on a horizontal line with two endpoints (left and right), with "0" representing "no pain" to "10" representing "severe pain."
Measured: visual analogue scale (VAS) after the surgery/injection (day 1) till 10 days after (day 10 after the surgery/injection)
Itching
A vertical scale for wound itching was measured with a scale with five scores: no itching (0) mild itching (1point) moderate itching (2 points) severe itching (3 points) extremely severe (4 points)
Measured: visual analogue scale (VAS) after the surgery/injection (day 1) till 10 days after (day 10 after the surgery/injection)
Patient satisfaction
using a 5- graded self-assessment analysis (Huh et al. 2003). excellent (grade 4: improved over 75%) good (grade 3: improved 50e75%) moderate (grade 2: improved 25e50%) fair (grade 1: improved less than 25%) no change or worse (grade 0: not improved or darkened)
Measured: At the end of the follow up period ( 9 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2026
- Study start1 Aug 2025
- Primary completionJan 2027 (estimated)
- Study completionOct 2027 (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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1. group 1 will be treated with conventional scalpel surgical depigmentation 2. group 2 will be treated with non-surgical intra-epidermal injection of vitamin C \& glutathione depigmentation. the following clinical measurements will be recorded. 1. The clinical assessment of the degree of gingival pigmentation will be performed using two different indices; * Takashi index * Gingival pigmentation index regular digital photographs which will be taken pre-operative, and post-operatively after 1, 3, 6 and 9 months. 2. Pain and itching will be reported by the patient after the surgical procedure and following each injection visit using visual analogue scale (VAS) at 24 hours 3. Patient satisfaction
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- Fayoum University
- Responsible party
- Principal investigator, Nourhan Abdallah Abdelkhalek, Cairo University
- Investigators
- Nourhan A Abdullah, Phd, Principal investigator, Lecturer at faculty of dentistry, Fayoum university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07595705
- Sponsor's protocol ID
- IRB00012891#159
- Status last verified
- May 2026
- First submitted
- 11 May 2026
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gingival Hyperpigmentation Treatment With Injectable Vitamin C in Conjunction With Glutathione Versus The Conventional Surgical Depigmentation: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07595705
- Acronym / sponsor ID
- IRB00012891#159
- Conditions
- Gingival Pigmentation, Depigmentation, Vitamin C, Glutathione
- Keywords
- depigmentation, vit c, glutathione, gingival depigmentation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- Fayoum University
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 19 May 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.
It is a clinical study conducted to evaluate the effect of vitamin C and Glucathonine injection of pigmented gingival tissue versus surgical removal by scalpel
Detailed description
Over the last decade, an increasing interest has been observed in esthetic treatments. In fact, The smile is an important aesthetic component of the face and significantly impacts the perception of beauty and psychological well-being. Gingival hyperpigmentation has been an aesthetic problem for many patients, which can definitely affect their psychosocial behavior.
Gingival hyperpigmentation is not a condition and can be defined as " a darker gingival color beyond what is normally expected". Moreover, it can be attributed to multiple external or internal factors. It may be physiological (excessive melanin deposition) or pathological (smoking).
Gingival Depigmentation can be treated by different modalities including chemical and surgical methods. Lately, gingival Depigmentation was carried out by lasers, cryosurgery and radiosurgery.
Additionally, multiple evidence have suggested the use of ascorbic acid (vitamin C) to treat gin- gival pigmentation. It was demonstrated that ascorbic acid is a water-soluble antioxidant and an essential nutrient for collagen biosynthesis. Furthermore, it was proven that it is effective in the elimination of hyperpigmented lesion.
Lately, glutathione has come into focus in aesthetics because of its antimelanogenic (inhibits melanosome transfer from melanocytes to keratinocytes) and antioxidant properties. It aids in skin lightening because it inhibits tyrosinase enzymes. Moreover, the use of vitamin C and glutathione has been well established, as they participate in antioxidant cellular defense systems. The series of oxidation-reduction reactions that allow vitamin C and glutathione to interact each other makes them unique The aim of the current study is to evaluate the efficacy of its rather-epidermal vitamin C in conjunction with glutathione injection compared to the conventional surgical technique in order to manage patients with gingival hyperpigmentation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 1. group 1 will be treated with conventional scalpel surgical depigmentation 2. group 2 will be treated with non-surgical intra-epidermal injection of vitamin C \& glutathione depigmentation. the following clinical measurements will be recorded. 1. The clinical assessment of the degree of gingival pigmentation will be performed using two different indices; * Takashi index * Gingival pigmentation index regular digital photographs which will be taken pre-operative, and post-operatively after 1, 3, 6 and 9 months. 2. Pain and itching will be reported by the patient after the surgical procedure and following each injection visit using visual analogue scale (VAS) at 24 hours 3. Patient satisfaction
| Arm | Type | Receives |
|---|---|---|
| Arm1:(Vit C & glutathione injection) | Experimental | Drug: Vitamin c and glutathioneThe site of interest will be anesthetized using topical anesthetic agent (lignocaine gel or xylocaine gel). Infiltration anesthesia will be recommended during the first injection visit. Intraepidermal injection of 1-1.5 ml of vitamin C and glutathione will be performed. It will be locally introduced in relation to the keratinized gingival tissues with extension to the whole target region successively using special syringes (50 gauge). The needle will be introduced parallel to the gingival tissues with the bevel facing upwards. Vitamin C \& glutathione will then be delivered through the attached gingival tissues at the epithelium-connective tissue junction (equivalent to epidermal- dermal junction) till the tissues blanch. Maximum 0.1 ml of injection is recommended for each point with 2-3 mm apart. The same dose will be repeated once per week for maximum 4 visits till no further color improvement gained. |
| ATM 2: surgical depigmentation | Active comparator | Procedure: Surgical depigmentationUsing a 15c blade an epithelial layer and part of connective tissue will be removed till the pigmentation disappears with ultra care not to expose the bone. The marginal and interdental papillary tissues remain critical regions, fortunately, they are not deeply pigmented. Periodontal dressing is recommended for minimal 7 days postoperative. Patients will be instructed to avoid the mechanical trauma to the treated sites. Patients will be administering an analgesic (Ibuprofen 400 mg) to be used as needed. Following each injection visit, the patients will be asked to abstain from mechanical oral hygiene procedures in relation to the target region for the day of procedure only. Plain tooth pastes (Colgate toothpaste) with anti- inflammatory mouthwash (Citrolin mouth, Pharco Company, Egypt) were recommended. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- The selection criteria were done according to Gingival pigmentation index is as follows (Dummett and Bolden)10:
- Score0:absence of pigmentation
- Score1:spotsofbrowntoblackcolororpigments
- Score2:browntoblackpatchesbutnotdiffusepigmentation
- Score3:diffuse brown to black pigmentation,marginal,and attached.
Key exclusion criteria (6 listed)
- systemic diseases associated with pathological hyperpigmentation or improper delayed wound healing (uncontrolled diabetes, autoimmune diseases, etc.)
- pregnant and lactating mothers
- usage of chlorhexidine or povidone iodine
- Local causes (smoking)
- periodontal diseases (plaque and non-plaque induced gingivitis or periodontitis)
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 |
|---|---|---|
| Vitamin c and glutathioneVitamins c and glutathione injection that usually used for cosmetic skin care (whitening) | Drug | Arm1:(Vit C & glutathione injection) |
| Surgical depigmentationRemoval of gingival pigmentation by scalpel | Procedure or surgery | ATM 2: surgical depigmentation |
Primary outcome
Degree of gingival pigmentation by Takashi index (Hanioka et al., 2005)
Time frame: baseline: before surgery/injection (day1), after 1 mon ,3 mon ,6 mon and 9 month
Degree of gingival pigmentation 0: no pigmentation 1. solitary unit (s) of pigmentation in papillary gingiva without extension between neighboring solitary units 2. formation of continuous ribbon extending from neighboring solitary units)
Degree of gingival pigmentation by Gingival pigmentation index (Kumar et al., 2013)
Time frame: The color assessment will be evaluated in the daylight and by examining the regular digital photographs which will be taken pre-operative (day of the procedure / day 1), and post-operatively after 1 month and 9 months.
Score 0: absence Score 1: spots of brown to black Score 2: brown to black patches but not diffuse Score 3: diffuse brown to black pigmentation
3 secondary outcomes
Pain score
Time frame: visual analogue scale (VAS) after the surgery/injection (day 1) till 10 days after (day 10 after the surgery/injection)
Itching
Time frame: visual analogue scale (VAS) after the surgery/injection (day 1) till 10 days after (day 10 after the surgery/injection)
Patient satisfaction
Time frame: At the end of the follow up period ( 9 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 19 May 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Gingival Pigmentation
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Gingival Depigmentation Using a 940 nm Diode Laser Versus Ceramic Bur
Physiologic Gingival Melanin Pigmentation
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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
Vitamin C for Gingival Depigmentation
Gingival Hyperpigmentation, Gingival Melanin Pigmentation
Recruiting
Clinical Evaluation of Microneedling Technique With Topical Application of Silymarin on Gingival Hyperpigmentation in Comparison With Diode Laser and Scalpel Methods.
Gingival Pigmentation, Gingival Hyperpigmentaion
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.
Nourhan A Abdullah, Phd principal investigator
Lecturer at faculty of dentistry, Fayoum university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vitamin c and glutathione and Surgical depigmentation in people with Gingival Pigmentation and Depigmentation, run by Cairo 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 10 inclusion and 6 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 19 May 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Nourhan A Abdelkhalek (01005802478, naa14@fayoum.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of gingival pigmentation by Takashi index (Hanioka et al., 2005) (time frame: baseline: before surgery/injection (day1), after 1 mon ,3 mon ,6 mon and 9 month). 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 19 May 2026; AzTrials last refreshed its copy on 27 Oct 2026.