Gingival Depigmentation Using Diode Laser 940nm Versus 980nm

Gingival Depigmentation Using Diode Laser 940nm Versus 980nm: A Split-mouth Comparative Clinical Trial

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06167148

Enrollment

Registered

2023-12-12

Start date

2021-10-01

Completion date

2023-11-22

Last updated

2023-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gingival Pigmentation

Brief summary

is study aimed to evaluate the effectiveness of two diode lasers of different wave lengths 940nm and 980nm for the treatment of physiologic gingival melanin hyperpigmentation.

Interventions

DEVICEBiolase Epic X 940nm wavelength Diode laser

Participants were treated with Biolase Epic X 940nm wavelength Diode laser set at a power of 1 W, fiber 400 µ, irradiation mode: pulsed wave (P3).

DEVICEDoctor smile simpler 980nm wavelength Diode laser

Participants were treated with doctor smile simpler 980nm wavelength Diode laser set at a power of 1 W, fiber 400 µ, irradiation mode: pulsed wave (SP).

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* Patients of both sexes diagnosed clinically with physiologic gingival pigmentation. * Pigmentation extending from canine to canine in either upper or lower arch.

Exclusion criteria

* Smokers. * Patients with uncontrolled metabolic disease. * Immuno-compromised patients. * Patients with renal disease. * Patients having coagulation disorders. * Pregnant and lactating women. * Evidence about the relation of pigmentation with malignancies. * History of previous treatment of gingival pigmentation.

Design outcomes

Primary

Measure	Time frame	Description
Intensity of pigmentation	up to 12 weeks	Intensity of pigmentation was assessed with Dummett Oral Pigmentation Index (DOPI 1971). DOPI was scored as: Score 1: No clinical pigmentation (pink gingiva) Score 2: Mild clinical pigmentation (mild light brown color) Score 3: Moderate clinical pigmentation (medium brown or mixed pink and brown) Score 4: Heavy clinical pigmentation (deep brown or bluish black).
Extension of pigmentation	up to 12 weeks	Extension of pigmented area was assessed by, Hedin Melanin Index (HMI). It was scored as: Degree 1: Isolated-only 1 or 2 pigmented interdental papillae Degree 2: Numerous pigmented interdental papillae Degree 3: Short continuous ribbons Degree 4: Long continuous ribbon

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026