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Completed

NCT Number: NCT06167148

Gingival Depigmentation Using Diode Laser 940nm Versus 980nm

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.

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Key information

Conditions

Gingival Pigmentation

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Alexandria University

Alexandria, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Biolase Epic X 940nm wavelength Diode laser

Device

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).

Doctor smile simpler 980nm wavelength Diode laser

Device

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).

Primary outcomes

  1. Intensity of pigmentation

    Time frame: 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).

  2. Extension of pigmentation

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Nourhan M.Aly

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Dec 12, 2023
Registry last updated
Dec 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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