Gingival PigmentationPhase 1/2NCT07070024
Efficacy of Microneedling With Vitamin C in Performing Gingival Depigmentation
A Phase 1/2 study testing Vitamin C, Microneedling and Diode laser in people with Gingival Pigmentation, run by Fayoum University.
Trial summary
The present study will be carried to clinically evaluate the efficacy of microneedling with vitamin C in performing gingival depigmentation in comparison with conventional scalpel and diode laser. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Gingival Pigmentation
- What is being tested?
- Vitamin C, Microneedling and Diode laser
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jul 2025to Dec 2026
- Phase
- Phase 1/2
- 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 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with bilateral, diffuse and symmetric physiologic gingival pigmentation in the labial maxillary or mandible gingiva.
- Patients free from any systemic diseases according to criteria of Modified Cornell Medical Index. (Abramson J et al., 1966)
- Periodontally healthy patient.
- Patients with age between 18 and 50 years
Who cannot join
- Smokers.
- Drugs intake "mainly those associated with gingival pigmentation".
- Pregnant and lactating women.
- Patients with thin gingival phenotype "with scalpel group".
- Gingival pigmentation associated with occupational hazards.
- Individuals undergoing chemotherapy
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Efficacy of Microneedling With Vitamin C in Performing Gingival Depigmentation Compared With Conventional Scalpel and Diode Laser: A Randomized Controlled Trial
The present study will be carried to clinically evaluate the efficacy of microneedling with vitamin C in performing gingival depigmentation in comparison with conventional scalpel and diode laser.
Read the detailed description
Gingival depigmentation can be considered a periodontal plastic procedure, whereby the gingival hyperpigmentation is removed by various techniques where the technique selection should primarily be based on clinical experiences and individual preferences with primary indication of demand for improved esthetics. Different techniques for depigmentation include: Scalpel technique, Cryosurgery, Electrosurgery, Lasers as neodymium-doped yttrium aluminum garnet (Nd: YAG), Erbium-doped yttrium-aluminum-garnet (Er: YAG) laser, Carbon dioxide laser CO2 and diode laser. also, Chemical methods including acoustic agents (not used nowadays) was used for treatment of gingival pigmentation. Other methods as free gingival graft and acellular dermal matrix allograft can also be used where the aim is masking the pigmented gingiva. Diode laser is a high-power semiconductor laser that emits energy at a wavelength between 800 and 1000 nm. It has an affinity for hemoglobin and melanin; therefore, it is more efficient and better equipped to address deeper soft tissue problems. It is indicated for cutting and coagulatinggingiva and oral mucosa, creating zones of thermal necrosis of less than 1 mm and hemostasis of the affected mucosa. It has been reported as effective, pleasant and reliable method with minimal postoperative discomfort, less bleeding, low recurrent rate and faster wound healing for depigmentation procedure. The light of this laser is emitted through synthetic sapphire tips in contact mode then transmitted to optical fibers to etch or vaporize soft tissues. Vitamin C , also known as ascorbic acid, is a water-soluble vitamin that has significant antioxidant properties that protects cells from free radical damage. In addition, vitamin C also nurtures the growth and repair of skin, cartilage, bone, and teeth. Vitamin C was reported to be effective in reducing melanogenesis directly and thus promoting depigmentation. This is accomplished by interacting with tyrosinase, leading to the suppression of tyrosinase enzyme activity and, consequently, a reduction in melanin production. Vitamin C affects melanocyte function rather than the number, when compared with other approaches that relying on the destruction of melanocytes. The food and drug administration (FDA) has legally authorized microneedling (MN) devices to improve the appearance of facial acne scars, facial wrinkles, and abdominal scars. However, there are various types of MN devices including dermaroller, dermastamp, and dermapen. Dermapen is the only device that can be applied intraorally due to its small size and changeable head. This increases the accessibility inside the mouth and makes it easy to be used for a larger number of patients. This device is a wireless electric device with automated features that allow the operator to modify the speeds, pressures, and depth of penetration. It was necessary to generate precise bleeding pinpoints by MN to achieve optimal results. These microholes allow the therapeutic medication to penetrate easily into the connective tissues, stimulating new collagen production and affecting melanocytes.
- Conditions
- Gingival Pigmentation
- Being tested
- Vitamin C, Microneedling, Diode laser, scalpal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin CDrug
Topical ascorbic acid powder, (1,000 mg/mL) mixed with saline will be applied over the gingiva for 10 minutes.
MicroneedlingDevice
MN will be achieved using a Dermapen device. c) The device allows for adjustable penetration depth, ranging from 0.2 mm to 3 mm, based on the gingival thickness. d) The needle tip comprises 12 to 24 needles arranged in rows, providing six-speed modes that span from 412 cycles/min at the lowest speed to 700 cycles/min at the highest speed. e) The Dermapen will be positioned perpendicular to the gingival surface, and microneedling will be executed horizontally, vertically, and diagonally approximately four to five times f) Across the entire hyperpigmented gingival surface until subtle microbleeding and mild erythema became evident Each individual will be undergoing a total of three treatment sessions of microneedling, spaced out by 10 days
Diode laserDevice
Energy output, pulse duration, and focal distance will be determined based on manufactures instruction. b) Patient, doctor and assistant will wear protective glass before starting the procedure. c) Depigmentation will be carried out using semiconductor Sirolaser Blue With proper isolation, depigmentation procedure will be done. e) Laser ablation will be started from the mucogingival junction toward the free gingival margin, including interdental papilla. f) The laser beam will be applied using the "brush technique," as described by Tal (Tal et al.,2003) and the tip will be kept in motion all the time. g) Remnants of the ablated tissue will be removed using sterile gauze dampened with saline solution
scalpalProcedure or surgery
Employing surgical blade number 15c, the gingival epithelium in the pigmented area will be excised. c) The blade will be oriented roughly parallel to the elongated axis of the teeth. d) A meticulous assessment of the revealed connective tissue surface will be performed, and any residual tissue tags will be removed with surgical scissors. e) Hemorrhage control will be managed by applying a pressure pack, and after achieving hemostasis, a periodontal dressing (a non-eugenol zinc oxide dressing) will be administered to cover the wound for one week.
| Study group | Role | What they receive |
|---|---|---|
| Microneedling with vitamin C | Active comparator | Prior to the MN procedure, local infiltration anesthesia will be administered as used in control group b) MN will be achieved using a Dermapen device. * c) The device allows for adjustable penetration depth, ranging from 0.2 mm to 3 mm, based on the gingival thickness. d) The needle tip comprises 12 to 24 needles arranged in rows, providing six-speed modes that span from 412 cycles/min at the lowest speed to 700 cycles/min at the highest speed. e) The Dermapen will be positioned perpendicular to the gingival surface, and microneedling will be executed horizontally, vertically, and diagonally approximately four to five times f) Across the entire hyperpigmented gingival surface until subtle microbleeding and mild erythema became evident. g) Topical ascorbic acid powder **, (1,000 mg/mL) mixed with saline will be applied over the gingiva for 10 minutes. h) Each individual will be undergoing a total of three treatment sessions of microneedling, spaced out by 10 days Receives: Drug: Vitamin C; Device: Microneedling |
| Diode laser | Active comparator | Topical anesthetic spray will be applied to the operating area. Energy output, pulse duration, and focal distance will be determined based on manufactures instruction. b) Patient, doctor and assistant will wear protective glass before starting the procedure. c) Depigmentation will be carried out using semiconductor Sirolaser BlueWith proper isolation, depigmentation procedure will be done. e) Laser ablation will be started from the mucogingival junction toward the free gingival margin, including interdental papilla. f) The laser beam will be applied using the "brush technique," as described by Tal (Tal et al.,2003) and the tip will be kept in motion all the time. g) Remnants of the ablated tissue will be removed using sterile gauze dampened with saline solution Receives: Device: Diode laser |
| scalpal surgery | Active comparator | Local anesthesia will be administered through infiltration (2% lidocaine with epinephrine 1:100,000) * at the surgical site. b) Employing surgical blade number 15c, the gingival epithelium in the pigmented area will be excised. c) The blade will be oriented roughly parallel to the elongated axis of the teeth. d) A meticulous assessment of the revealed connective tissue surface will be performed, and any residual tissue tags will be removed with surgical scissors. e) Hemorrhage control will be managed by applying a pressure pack, and after achieving hemostasis, a periodontal dressing (a non-eugenol zinc oxide dressing) will be administered to cover the wound for one week Receives: Procedure: scalpal |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome is the efficacy of gingival depigmentation.
The primary outcome is the assessment of how well the treatment removes or reduces the appearance of dark (pigmented) areas on the gums. This is often evaluated using a standardized index like the Degree of Oral Pigmentation Index (DOPI).
The efficacy of different techniques ( surgical scalpal, laser, microneedling with vitamin C is then compared based on the degree of pigmentation reduction achieved and the rate of repigmentation over time Degree of gingival pigmentation will be done using Oral Pigmentation
Index (Dummett et al ;1964) as following:
(0) pink tissue, no clinical pigmentation.
- mild light brown tissue, mild clinical pigmentation.
- medium brown or mixed brown and pink tissue, moderate clinical pigmentation.
- deep brown/blue-black tissue, heavy clinical pigmentation.
Measured: baseline , 3 months , 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2025
- Study startJul 2025 (estimated)
- Primary completion1 Jul 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Gingival PigmentationStudies of the same condition, open and under way.
- More trials run by Fayoum 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- MN will be achieved using a Dermapen device. \*\*\* c) The device allows for adjustable penetration depth, ranging from 0.2 mm to 3 mm, based on the gingival thickness. d) The needle tip comprises 12 to 24 needles arranged in rows, providing six-speed modes that span from 412 cycles/min at the lowest speed to 700 cycles/min at the highest speed. e) The Dermapen will be positioned perpendicular to the gingival surface, and microneedling will be executed horizontally, vertically, and diagonally approximately four to five times f) Across the entire hyperpigmented gingival surface until subtle microbleeding and mild erythema became evident. g) Topical ascorbic acid powder \*\*\*\*, (1,000 mg/mL) mixed with saline will be applied over the gingiva for 10 minutes. h) Each individual will be undergoing a total of three treatment sessions of microneedling, spaced out by 10 days
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fayoum University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa Eid Ragab Abdelal, Fayoum University
- Investigators
- Rehab Ahmed Dr/ Rehab Ahmed Osman, Lecturer, Study director, faculty of dentistry Fayoum university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07070024
- Sponsor's protocol ID
- gingival depigmentation
- Status last verified
- Jul 2025
- First submitted
- 13 May 2025
- Last updated
- 17 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
P SM, S S. Comparative Assessment of Gingival Depigmentation Using Scalpel Versus Microneedling With Ascorbic Acid: A Randomized Controlled Trial. Cureus. 2024 Apr 15;16(4):e58285. doi: 10.7759/cureus.58285. eCollection 2024 Apr.
PubMed 38752063Murthy MB, Kaur J, Das R. Treatment of gingival hyperpigmentation with rotary abrasive, scalpel, and laser techniques: A case series. J Indian Soc Periodontol. 2012 Oct;16(4):614-9. doi: 10.4103/0972-124X.106933.
PubMed 23493062Mostafa D Sr, A Alaizari N, M AlOtaibi S, Ahmed Aldosari N, Rabie Al-Anazi J, S Alsughayer R, M AlFayir H, S AlHarthi M, H AlAnazi M. Gingival Depigmentation Using Microneedling Technique With Topical Vitamin C: A Prospective Case Series. Cureus. 2023 Feb 23;15(2):e35345. doi: 10.7759/cureus.35345. eCollection 2023 Feb.
PubMed 36974245Abramson JH. The cornell medical index as an epidemiological tool. Am J Public Health Nations Health. 1966 Feb;56(2):287-98. doi: 10.2105/ajph.56.2.287. No abstract available.
PubMed 5948222
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Microneedling With Vitamin C in Performing Gingival Depigmentation Compared With Conventional Scalpel and Diode Laser: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07070024
- Acronym / sponsor ID
- gingival depigmentation
- Conditions
- Gingival Pigmentation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Fayoum UniversityUniversity, hospital or other
- Study start
- Jul 2025 (estimated)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 17 Jul 2025 (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 present study will be carried to clinically evaluate the efficacy of microneedling with vitamin C in performing gingival depigmentation in comparison with conventional scalpel and diode laser.
Detailed description
Gingival depigmentation can be considered a periodontal plastic procedure, whereby the gingival hyperpigmentation is removed by various techniques where the technique selection should primarily be based on clinical experiences and individual preferences with primary indication of demand for improved esthetics. Different techniques for depigmentation include: Scalpel technique, Cryosurgery, Electrosurgery, Lasers as neodymium-doped yttrium aluminum garnet (Nd: YAG), Erbium-doped yttrium-aluminum-garnet (Er: YAG) laser, Carbon dioxide laser CO2 and diode laser. also, Chemical methods including acoustic agents (not used nowadays) was used for treatment of gingival pigmentation. Other methods as free gingival graft and acellular dermal matrix allograft can also be used where the aim is masking the pigmented gingiva. Diode laser is a high-power semiconductor laser that emits energy at a wavelength between 800 and 1000 nm. It has an affinity for hemoglobin and melanin; therefore, it is more efficient and better equipped to address deeper soft tissue problems. It is indicated for cutting and coagulatinggingiva and oral mucosa, creating zones of thermal necrosis of less than 1 mm and hemostasis of the affected mucosa. It has been reported as effective, pleasant and reliable method with minimal postoperative discomfort, less bleeding, low recurrent rate and faster wound healing for depigmentation procedure. The light of this laser is emitted through synthetic sapphire tips in contact mode then transmitted to optical fibers to etch or vaporize soft tissues. Vitamin C , also known as ascorbic acid, is a water-soluble vitamin that has significant antioxidant properties that protects cells from free radical damage. In addition, vitamin C also nurtures the growth and repair of skin, cartilage, bone, and teeth. Vitamin C was reported to be effective in reducing melanogenesis directly and thus promoting depigmentation. This is accomplished by interacting with tyrosinase, leading to the suppression of tyrosinase enzyme activity and, consequently, a reduction in melanin production. Vitamin C affects melanocyte function rather than the number, when compared with other approaches that relying on the destruction of melanocytes. The food and drug administration (FDA) has legally authorized microneedling (MN) devices to improve the appearance of facial acne scars, facial wrinkles, and abdominal scars. However, there are various types of MN devices including dermaroller, dermastamp, and dermapen. Dermapen is the only device that can be applied intraorally due to its small size and changeable head. This increases the accessibility inside the mouth and makes it easy to be used for a larger number of patients. This device is a wireless electric device with automated features that allow the operator to modify the speeds, pressures, and depth of penetration. It was necessary to generate precise bleeding pinpoints by MN to achieve optimal results. These microholes allow the therapeutic medication to penetrate easily into the connective tissues, stimulating new collagen production and affecting melanocytes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- MN will be achieved using a Dermapen device. * c) The device allows for adjustable penetration depth, ranging from 0.2 mm to 3 mm, based on the gingival thickness. d) The needle tip comprises 12 to 24 needles arranged in rows, providing six-speed modes that span from 412 cycles/min at the lowest speed to 700 cycles/min at the highest speed. e) The Dermapen will be positioned perpendicular to the gingival surface, and microneedling will be executed horizontally, vertically, and diagonally approximately four to five times f) Across the entire hyperpigmented gingival surface until subtle microbleeding and mild erythema became evident. g) Topical ascorbic acid powder **, (1,000 mg/mL) mixed with saline will be applied over the gingiva for 10 minutes. h) Each individual will be undergoing a total of three treatment sessions of microneedling, spaced out by 10 days
| Arm | Type | Receives |
|---|---|---|
| Microneedling with vitamin C | Active comparator | Drug: Vitamin C, Device: MicroneedlingPrior to the MN procedure, local infiltration anesthesia will be administered as used in control group b) MN will be achieved using a Dermapen device. * c) The device allows for adjustable penetration depth, ranging from 0.2 mm to 3 mm, based on the gingival thickness. d) The needle tip comprises 12 to 24 needles arranged in rows, providing six-speed modes that span from 412 cycles/min at the lowest speed to 700 cycles/min at the highest speed. e) The Dermapen will be positioned perpendicular to the gingival surface, and microneedling will be executed horizontally, vertically, and diagonally approximately four to five times f) Across the entire hyperpigmented gingival surface until subtle microbleeding and mild erythema became evident. g) Topical ascorbic acid powder **, (1,000 mg/mL) mixed with saline will be applied over the gingiva for 10 minutes. h) Each individual will be undergoing a total of three treatment sessions of microneedling, spaced out by 10 days |
| Diode laser | Active comparator | Device: Diode laserTopical anesthetic spray will be applied to the operating area. Energy output, pulse duration, and focal distance will be determined based on manufactures instruction. b) Patient, doctor and assistant will wear protective glass before starting the procedure. c) Depigmentation will be carried out using semiconductor Sirolaser BlueWith proper isolation, depigmentation procedure will be done. e) Laser ablation will be started from the mucogingival junction toward the free gingival margin, including interdental papilla. f) The laser beam will be applied using the "brush technique," as described by Tal (Tal et al.,2003) and the tip will be kept in motion all the time. g) Remnants of the ablated tissue will be removed using sterile gauze dampened with saline solution |
| scalpal surgery | Active comparator | Procedure: scalpalLocal anesthesia will be administered through infiltration (2% lidocaine with epinephrine 1:100,000) * at the surgical site. b) Employing surgical blade number 15c, the gingival epithelium in the pigmented area will be excised. c) The blade will be oriented roughly parallel to the elongated axis of the teeth. d) A meticulous assessment of the revealed connective tissue surface will be performed, and any residual tissue tags will be removed with surgical scissors. e) Hemorrhage control will be managed by applying a pressure pack, and after achieving hemostasis, a periodontal dressing (a non-eugenol zinc oxide dressing) will be administered to cover the wound for one week |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients with bilateral, diffuse and symmetric physiologic gingival pigmentation in the labial maxillary or mandible gingiva.
- Patients free from any systemic diseases according to criteria of Modified Cornell Medical Index. (Abramson J et al., 1966)
- Periodontally healthy patient.
- Patients with age between 18 and 50 years
Key exclusion criteria (6 listed)
- Smokers.
- Drugs intake "mainly those associated with gingival pigmentation".
- Pregnant and lactating women.
- Patients with thin gingival phenotype "with scalpel group".
- Gingival pigmentation associated with occupational hazards.
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 CTopical ascorbic acid powder, (1,000 mg/mL) mixed with saline will be applied over the gingiva for 10 minutes. | Drug | Microneedling with vitamin C |
| MicroneedlingMN will be achieved using a Dermapen device. c) The device allows for adjustable penetration depth, ranging from 0.2 mm to 3 mm, based on the gingival thickness. d) The needle tip comprises 12 to 24 needles arranged in rows, providing six-speed modes that span from 412 cycles/min at the lowest speed to 700 cycles/min at the highest speed. e) The Dermapen will be positioned perpendicular to the gingival surface, and microneedling will be executed horizontally, vertically, and diagonally approximately four to five times f) Across the entire hyperpigmented gingival surface until subtle microbleeding and mild erythema became evident Each individual will be undergoing a total of three treatment sessions of microneedling, spaced out by 10 days | Device | Microneedling with vitamin C |
| Diode laserEnergy output, pulse duration, and focal distance will be determined based on manufactures instruction. b) Patient, doctor and assistant will wear protective glass before starting the procedure. c) Depigmentation will be carried out using semiconductor Sirolaser Blue With proper isolation, depigmentation procedure will be done. e) Laser ablation will be started from the mucogingival junction toward the free gingival margin, including interdental papilla. f) The laser beam will be applied using the "brush technique," as described by Tal (Tal et al.,2003) and the tip will be kept in motion all the time. g) Remnants of the ablated tissue will be removed using sterile gauze dampened with saline solution | Device | Diode laser |
| scalpalEmploying surgical blade number 15c, the gingival epithelium in the pigmented area will be excised. c) The blade will be oriented roughly parallel to the elongated axis of the teeth. d) A meticulous assessment of the revealed connective tissue surface will be performed, and any residual tissue tags will be removed with surgical scissors. e) Hemorrhage control will be managed by applying a pressure pack, and after achieving hemostasis, a periodontal dressing (a non-eugenol zinc oxide dressing) will be administered to cover the wound for one week. | Procedure or surgery | scalpal surgery |
Primary outcome
The primary outcome is the efficacy of gingival depigmentation.
Time frame: baseline , 3 months , 6 months
The primary outcome is the assessment of how well the treatment removes or reduces the appearance of dark (pigmented) areas on the gums. This is often evaluated using a standardized index like the Degree of Oral Pigmentation Index (DOPI). The efficacy of different techniques ( surgical scalpal, laser, microneedling with vitamin C is then compared based on the degree of pigmentation reduction achieved and the rate of repigmentation over time Degree of gingival pigmentation will be done using Oral Pigmentation Index (Dummett et al ;1964) as following: (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. 3. deep brown/blue-black tissue, heavy clinical pigmentation.
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 17 Jul 2025.
- Results publication: PubMed 38752063P SM, S S. Comparative Assessment of Gingival Depigmentation Using Scalpel Versus Microneedling With Ascorbic Acid: A Randomized Controlled Trial. Cureus. 2024 Apr 15;16(4):e58285. doi: 10.7759/cureus.58285. eCollection 2024 Apr.
- Results publication: PubMed 23493062Murthy MB, Kaur J, Das R. Treatment of gingival hyperpigmentation with rotary abrasive, scalpel, and laser techniques: A case series. J Indian Soc Periodontol. 2012 Oct;16(4):614-9. doi: 10.4103/0972-124X.106933.
- Results publication: PubMed 36974245Mostafa D Sr, A Alaizari N, M AlOtaibi S, Ahmed Aldosari N, Rabie Al-Anazi J, S Alsughayer R, M AlFayir H, S AlHarthi M, H AlAnazi M. Gingival Depigmentation Using Microneedling Technique With Topical Vitamin C: A Prospective Case Series. Cureus. 2023 Feb 23;15(2):e35345. doi: 10.7759/cureus.35345. eCollection 2023 Feb.
- Results publication: PubMed 5948222Abramson JH. The cornell medical index as an epidemiological tool. Am J Public Health Nations Health. 1966 Feb;56(2):287-98. doi: 10.2105/ajph.56.2.287. No abstract available.
- 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.
Rehab Ahmed Dr/ Rehab Ahmed Osman, Lecturer study director
faculty of dentistry Fayoum university
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Vitamin C, Microneedling and Diode laser in people with Gingival Pigmentation, run by Fayoum 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 4 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: opening soon, as of the sponsor's last update on 17 Jul 2025. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Asmaa Eid Abdelal, resident (+0201025041804, asmaaeid402@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome is the efficacy of gingival depigmentation. (time frame: baseline , 3 months , 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07070024, which also lists 4 linked publications.
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 17 Jul 2025; AzTrials last refreshed its copy on 7 Nov 2026.