Vitamin C Mesotherapy Versus Diode Laser for the Management of Physiologic Gingival Pigmentation

Hams Hamed Abdelrahman26 enrolled

Overview

Physiologic pigmentation affects the gingival esthetics. Laser ablation has been recently used as the most effective and reliable technique for gingival depigmentation. However, the high cost of laser technology limits its use in dental practice. Vitamin C/Ascorbic acid mesotherapy has been proposed as a minimally invasive, safe, cost-effective new modality of treatment.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Gingival Pigmentation

Interventions

Vitamin C mesotherapyOTHER

Vitamin C intra-mucosal injection; in which the site of interest will be anesthetized using a topical anesthetic agent (lidocaine gel or xylocaine gel) or infiltration anesthesia, followed by intra-mucosal field injections of 1-1.5 ml Cevarol (L-Ascorbic acid 1000 mg/5 ml

Diode laserRADIATION

Diode laser ablation: in which the site of interest will be anesthetized using infiltration anesthesia, followed by laser ablation. 980nm Diode laser will be applied using the following setting parameters: continuous mode with 980nm wavelength at 1.5 W output power.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adults between 18 and 45 years old with physiologic melanin pigmentation in the anterior esthetic portion of the maxillary or mandibular gingiva. * Systemically free Exclusion Criteria: * Smokers. * Drugs intake, which associates with gingival melanin pigmentation. * Pregnant and lactating women. * Patients with known hypersensitivity to ascorbic acid. * Patients with bad oral hygiene. * Pigmentation of the gingiva due to heavy metal ingestion

Locations (1)

Alexandria Faculty of Dentistry

Alexandria, Egypt

Outcomes

Primary Outcomes

Change in gingival pigmentation score

Score 0: Absence of pigmentation Score 1: Spots of brown to black color or pigments. Score 2: Brown to black patches but not diffuse pigmentation Score 3: Diffuse brown to black pigmentation, marginal, and attached gingiva

Time frame: baseline, 1 month, 2 months

Secondary Outcomes

Change in pain score

Visual Analogue Scale (VAS) is a simple measurement tool that measures the intensity of pain as recorded by the patient. 10 point visual analog scale of pain rating, the left side is marked "no pain" and the right side marked "worst pain imaginable.

Time frame: up to 1 week

Patient satisfaction

After 2 months, patients will be asked to answer three questions to evaluate the level of satisfaction with each technique: Did you notice a cosmetic change 2 months after the treatment? (1) No, (2) Moderate, (3) Marked Did treatment meet your expectation? (1) No, (2) yes, (3) Over and above Would you repeat treatment if necessary? (1) No, (2) yes

Time frame: after 2 months

Data from ClinicalTrials.gov

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