Efficacy of Microneedling With Vitamin C in Performing Gingival Depigmentation

NCT07070024 | Not Yet Recruiting Phase 1 DMC FDA Device

• 1 other identifier: gingival depigmentation
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Gingival Pigmentation

Outcome Measures

Primary Outcomes (1)

• 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. 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.

  baseline , 3 months , 6 months

Study Arms (3)

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

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

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

Procedure: scalpal

Interventions

Vitamin C DRUG

Topical ascorbic acid powder, (1,000 mg/mL) mixed with saline will be applied over the gingiva for 10 minutes.

Microneedling with vitamin C

Microneedling DEVICE

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

Microneedling with vitamin C

Diode laser DEVICE

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

Diode laser

scalpal PROCEDURE

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.

scalpal surgery

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fayoum University: lead

Related Publications (4)

• 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.

  PMID: 38752063 BACKGROUND

• Murthy 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.

  PMID: 23493062 BACKGROUND

• Mostafa 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.

  PMID: 36974245 BACKGROUND

• Abramson 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.

  PMID: 5948222 BACKGROUND

MeSH Terms

Interventions

Ascorbic Acid; Percutaneous Collagen Induction; Lasers, Semiconductor

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Punctures; Rehabilitation; Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• Rehab Ahmed Dr/ Rehab Ahmed Osman, Lecturer

  faculty of dentistry Fayoum university

  STUDY DIRECTOR

Central Study Contacts

Asmaa Eid Abdelal, resident

CONTACT

+0201025041804; asmaaeid402@gmail.com

Rehab Ahmed Osman, Lecturer

CONTACT

+0201153832971; rau11@fayoum.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident at oral medicine and periodontology department Fayoum university

Model Details: 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

Study Record Dates

• First Submitted: May 13, 2025
• First Posted: July 17, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 17, 2025

Record last verified: 2025-07