Efficacy of Microneedling With Vitamin C in Performing Gingival Depigmentation

Fayoum University

Status and phase: Not yet enrolling; Phase 2; Phase 1

Conditions: Gingival Pigmentation

Treatments: Device: Microneedling; Device: Diode laser; Drug: Vitamin C; Procedure: scalpal

Study type: Interventional

Funder types: Other

Identifiers

NCT07070024

gingival depigmentation

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients with bilateral, diffuse and symmetric physiologic gingival pigmentation in the labial maxillary or mandible gingiva.
2. Patients free from any systemic diseases according to criteria of Modified Cornell Medical Index. (Abramson J et al., 1966)
3. Periodontally healthy patient.
4. Patients with age between 18 and 50 years

Exclusion criteria

1. Smokers.
2. Drugs intake "mainly those associated with gingival pigmentation".
3. Pregnant and lactating women.
4. Patients with thin gingival phenotype "with scalpel group".
5. Gingival pigmentation associated with occupational hazards.
6. Individuals undergoing chemotherapy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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30 participants in 3 patient groups

Microneedling with vitamin C

Active Comparator group

Description:

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

Treatment:

Drug: Vitamin C

Device: Microneedling

Diode laser

Active Comparator group

Description:

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

Treatment:

Device: Diode laser

scalpal surgery

Active Comparator group

Description:

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

Treatment:

Procedure: scalpal