Efficacy of Microneedling With Vitamin C in Performing Gingival Depigmentation

Official title

Efficacy of Microneedling With Vitamin C in Performing Gingival Depigmentation Compared With Conventional Scalpel and Diode Laser: A Randomized Controlled Trial

Overview

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.

Interventions

• Drug Vitamin C
  Topical ascorbic acid powder, (1,000 mg/mL) mixed with saline will be applied over the gingiva for 10 minutes.
• Device Microneedling
  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 approxima
• Device Diode laser
  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 t
• Procedure scalpal
  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) wi

Primary outcome measures

• The primary outcome is the efficacy of gingival depigmentation. [Time frame: baseline , 3 months , 6 months]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Crossover

Masking

Single blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

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. PMID 38752063
• 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
• 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
• 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

Identifiers

NCT: NCT07070024 · gingival depigmentation

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗