Laser-Assisted Gingival Depigmentation

Academy of Laser Dentistry - Gulf Laser Chapter

Status: Completed

Conditions: Hyperpigmentation; Melanin; Laser-Induced Hyperpigmentation

Treatments: Device: Diode laser 940 nm; Device: Er,Cr:YSGG laser 2780 nm

Study type: Interventional

Funder types: Other

Identifiers

NCT04680806

GulfLaserChapter

Details and patient eligibility

About

This randomized clinical trial evaluated the recurrence rates of physiological gingival pigments during 24 months follow-up and the patient perceptions after the ablative depigmentation using two laser wavelengths; Diode 940 nm and Er,Cr:YSGG 2780 nm.

Full description

This study aim to compare the clinical outcomes, the rate of repigmentation, and the patient perceptions after laser-assisted gingival depigmentation with diode 940 nm and Erbium, chromium-doped yttrium, scandium, gallium and garnet (Er,Cr:YSGG) 2780 nm. Two pigmentation index were used to compare between the treatment outcomes of using Diode laser or Er,Cr:YSGG.

The depigmentation procedure essentially involves ablation of epithelial layer of buccal gingiva containing melanin pigmentation.

Sixty healthy patients (22 males and 38 females, aged 21 to 43 years) who presented with a chief complaint of having dark-brown to black gingival hyperpigmentation between April 2015 and September 2018. Participants were randomly divided into 2 groups (30 patients each). Randomization was carried out using randomization table; by a computer-generated randomization list (SPSS v23.0) with allocation ratio 1:1.

All of the patients were selected according to the study inclusion and exclusion criteria.

Data collection was done by a dental specialist who was blinded about the provided treatment. Data collections included the clinical examination at baseline and follow up appointments. To achieve blinding, three calibrated external experts, blinded to the provided treatment classified the degree of gingival pigments and gingival topography according oral pigmentation index (DOPI) and melanin pigmentation index.

The periodontal surgery was performed by a periodontist specialised in laser dentistry. The periodontist did not interfere with the treatment option.

Descriptive statistics and statistical analysis was done by an external expert using SPSS Statistics software(SPSS v23.0) . Nonparametric tests, Kruskal-Wallis test was used to compare between the two groups according the time intervals.

The patients who did not show in all the study follow up's appointments were dropped from the data analysis.

Patients were asked to evaluate the procedure by using a self-administered questionnaire. The patients were recalled after 1 week, 1 month, 12 months and 24 months.

Enrollment: 60 patients

Sex: All

Ages: 20+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• All patient exhibiting physiologic pigmentation of score2 or more according to Oral pigmentation index (DOPI)

Exclusion criteria

• Pathologic hyperpigmentation
• Participants with a systemic condition that could affect tissue healing (e. g., autoimmune diseases)
• Pregnancy and lactation
• History of smoking
• Previous mucogingival surgery at the region to be treated
• No contraindication for the laser treatment.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups

Er,Cr:YSGG laser 2780 nm

Experimental group

Description:

Group A was treated by an Er,Cr:YSGG laser 2780 nm cylindrical tip (tip 600 μm, 45 millijoule /pulse, average power 2.25 W, frequency 50 Hz, pulse duration 60 µs, energy density 43 J/cm2, water 50%, and air 40%). The procedure was performed completely without anesthesia with the laser tip at angulation \~30° and distance of \~1 mm from the gingival tissue. The laser tip was advancing in scanning movement from in the cervical-apical direction in all pigmented areas. The following settings was used to achieve hemostasis in case of the bleeding was present (tip 600 μm, 30 millijoule /pulse, average power 1.5 W, frequency 50 Hz, pulse duration 700 µs, energy density 28.7 J/cm2, water 10%, and air 20%).

Treatment:

Device: Er,Cr:YSGG laser 2780 nm

Diode laser 940 nm

Experimental group

Description:

Group B was treated with diode 940 nm Laser. The procedure was performed with a pencil-sized handpiece containing a 400 µm lasing fiber (400 μm initiated tip, average power 0.8 watts, Pulsed mode, Duty cycle 20%, Pulse duration 10 μs, energy density 636.9 J/cm2 per second, no water or air). Infiltration anesthesia was injected for B group . The laser tip was placed in angle \~30° with the gingival surface. Short light paint brush strokes were used in the cervical-apical direction in all pigmented areas.

Treatment:

Device: Diode laser 940 nm