Gingiival HyperpigmentationNCT07748507
Comparison of Gingival Depigmentation Using Microneedling and Microneedling With Glutathione Gel - A Split Mouth Clinical Trial
A study testing Microneedling using Dermapen device and Microneedling with 0.5 % Glutathione gel in people with Gingiival Hyperpigmentation, run by Krishnadevaraya College of Dental Sciences & Hospital at 1 site in India.
Trial summary
The colour of gingiva is important determinant of smile esthetics.Owing to increasing awareness and demand for cosmetic procedures over the past decade, gingival depigmentation has gained popularity among periodontal plastic surgical procedures. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Gingiival Hyperpigmentation
- What is being tested?
- Microneedling using Dermapen device and Microneedling with 0.5 % Glutathione gel
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteIndia
- Study dates
- 25 Jun 2025to 28 Jul 2026
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients between the age group of 18 to 45 years
- Systemically healthy subjects
- Maxillary or mandibular keratinised gingiva with minimum mean SEMPI score of 1(light grey / brown pigmentation) and above.
Who cannot join
- Patients with thin gingival phenotype(<1mm)
- Patients on drugs that cause oral pigmentation like antimalarials,minocycline, oral contraceptives etc.,
- Systemic disorders that cause oral pigmentation ,Pregnant and lactating women
- Subjects with history of smoking.
Trial locations and contacts
1 site in 1 country.
India1 site
krishnadevaraya college of dental sciences and Hospital
Bangalore, Kranataka, 562157
About this study
The colour of gingiva is important determinant of smile esthetics.Owing to increasing awareness and demand for cosmetic procedures over the past decade, gingival depigmentation has gained popularity among periodontal plastic surgical procedures.
Read the detailed description
various treatment modalities for depigmentation has been used over the decades. Microneedling is a minimally invasive procedure that creates micro pores on the gingiva which stimulates the natural healing process and improve penetration of topical agents.Glutathione when used has shown promising results in reducing pigmentation which is a major concern with the treatment. In this study 15 patients meeting the eligibility criteria has been randomly assigned to either of the arms.
- Conditions
- Gingiival Hyperpigmentation
- Being tested
- Microneedling using Dermapen device, Microneedling with 0.5 % Glutathione gel
- Keywords
- Microneedling, Glutathione, Depigmentation, Repigmentation
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microneedling using Dermapen deviceDevice
Dermapen device that is being used for microneedling creates micro conuits because of whuch wound healing will bee improved and it helps penetration of agents effectively
Microneedling with 0.5 % Glutathione gelOther
Usage of micreoneedling with topical application of 0.5% glutathione gel as an adjunct
| Study group | Role | What they receive |
|---|---|---|
| Microneedling using Dermapen device | Experimental | Not described Receives: Device: Microneedling using Dermapen device |
| Microneedling with 0.5% Glutathione gel | Experimental | In this arm dermapen device is used to reduce pigmentation Receives: Device: Microneedling using Dermapen device; Other: Microneedling with 0.5 % Glutathione gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Gingival pigmentation using SEMPI index
Severity and Extension of Gingival Melanotic Pigmentation Index is used for assessing the gingival pigmentation
Measured: baseline, 1 month, 3 months, 6 months
Assessment of pigment surface area using Image J analysis software
Measured: baseline, 1 month, 3 months, 6 months
Secondary outcomes (2)
Rate of repigmentation
Repigmentation rate assessed using change in sempi score and pigment surface area on image J over the period
Measured: 6 months
patient reported pain or discomfort
using visual analog scale
Measured: at the time of treatment , 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2026
- Study start25 Jun 2025
- Primary completion28 Dec 2025
- Study completion28 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingiival 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Krishnadevaraya College of Dental Sciences & Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Prabhuji MLV, Krishnadevaraya College of Dental Sciences & Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07748507
- Sponsor's protocol ID
- 02_D012_00116
- Status last verified
- Aug 2026
- First submitted
- 28 Jul 2026
- Last updated
- 5 Aug 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 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Gingival Depigmentation Using Microneedling and Microneedling With Glutathione Gel - A Split Mouth Clinical Trial
- ClinicalTrials.gov ID
- NCT07748507
- Acronym / sponsor ID
- 02_D012_00116
- Conditions
- Gingiival Hyperpigmentation
- Keywords
- Microneedling, Glutathione, Depigmentation, Repigmentation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Krishnadevaraya College of Dental Sciences & HospitalUniversity, hospital or other
- Study start
- 25 Jun 2025 (actual)
- Primary completion
- 28 Dec 2025 (actual)
- Study completion
- 28 Jul 2026 (actual)
- First posted
- 5 Aug 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 colour of gingiva is important determinant of smile esthetics.Owing to increasing awareness and demand for cosmetic procedures over the past decade, gingival depigmentation has gained popularity among periodontal plastic surgical procedures.
Detailed description
various treatment modalities for depigmentation has been used over the decades. Microneedling is a minimally invasive procedure that creates micro pores on the gingiva which stimulates the natural healing process and improve penetration of topical agents.Glutathione when used has shown promising results in reducing pigmentation which is a major concern with the treatment. In this study 15 patients meeting the eligibility criteria has been randomly assigned to either of the arms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Microneedling using Dermapen device | Experimental | Device: Microneedling using Dermapen device |
| Microneedling with 0.5% Glutathione gel | Experimental | Device: Microneedling using Dermapen device, Other: Microneedling with 0.5 % Glutathione gelIn this arm dermapen device is used to reduce pigmentation |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients between the age group of 18 to 45 years
- Systemically healthy subjects
- Maxillary or mandibular keratinised gingiva with minimum mean SEMPI score of 1(light grey / brown pigmentation) and above.
Key exclusion criteria (4 listed)
- Patients with thin gingival phenotype(<1mm)
- Patients on drugs that cause oral pigmentation like antimalarials,minocycline, oral contraceptives etc.,
- Systemic disorders that cause oral pigmentation ,Pregnant and lactating women
- Subjects with history of smoking.
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 using Dermapen deviceDermapen device that is being used for microneedling creates micro conuits because of whuch wound healing will bee improved and it helps penetration of agents effectively | Device | Microneedling using Dermapen device, Microneedling with 0.5% Glutathione gel |
| Microneedling with 0.5 % Glutathione gelUsage of micreoneedling with topical application of 0.5% glutathione gel as an adjunct | Other | Microneedling with 0.5% Glutathione gel |
Primary outcome
Assessment of Gingival pigmentation using SEMPI index
Time frame: baseline, 1 month, 3 months, 6 months
Severity and Extension of Gingival Melanotic Pigmentation Index is used for assessing the gingival pigmentation
Assessment of pigment surface area using Image J analysis software
Time frame: baseline, 1 month, 3 months, 6 months
2 secondary outcomes
Rate of repigmentation
Time frame: 6 months
patient reported pain or discomfort
Time frame: at the time of treatment , 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microneedling using Dermapen device and Microneedling with 0.5 % Glutathione gel in people with Gingiival Hyperpigmentation, run by Krishnadevaraya College of Dental Sciences & Hospital at 1 site in India.
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: finished, as of the sponsor's last update on 5 Aug 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 India. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Assessment of Gingival pigmentation using SEMPI index (time frame: baseline, 1 month, 3 months, 6 months). 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 5 Aug 2026.