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Gingival Depigmentation Using Diode Laser 940nm Versus 980nm

NCT06167148 — Not applicable, Completed, 20 participants, Nourhan M.Aly

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

RegistryNCT06167148
StatusCompleted
PhaseNot applicable
Study typeInterventional; randomized, crossover, masking: double, treatment
Enrollment20 (Actual)
SponsorNourhan M.Aly (Other)
ConditionsGingival Pigmentation
InterventionsBiolase Epic X 940nm wavelength Diode laser, Doctor smile simpler 980nm wavelength Diode laser (Device)
Datesstart 2021-10-01, primary completion 2023-11-20, completion 2023-11-22, first posted 2023-12-12, last updated 2023-12-12
Locations1 site in Egypt

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-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.

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+Arms and interventions

ArmTypeInterventionsDescription
940nm wavelength Diode laserExperimentalDevice: Biolase Epic X 940nm wavelength Diode laser
980nm wavelength Diode laserActive comparatorDevice: Doctor smile simpler 980nm wavelength Diode laser
  • 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).

+Outcome measures

Primary outcomes

  • 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

+Eligibility

Sex: All

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.

+Locations (1)

FacilityCityCountryStatus
Faculty of Dentistry, Alexandria UniversityAlexandriaEgypt

+Investigators

My Notes