Gingival Depigmentation Using Diode Laser 940nm Versus 980nm

NCT06167148 | Completed

• 1 other identifier: 5/23
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Gingival Pigmentation

Outcome Measures

Primary Outcomes (2)

• Intensity of pigmentation

  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).

  up to 12 weeks

• Extension of pigmentation

  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

  up to 12 weeks

Study Arms (2)

940nm wavelength Diode laser

EXPERIMENTAL

Device: Biolase Epic X 940nm wavelength Diode laser

980nm wavelength Diode laser

ACTIVE COMPARATOR

Device: Doctor smile simpler 980nm wavelength Diode laser

Interventions

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).

940nm wavelength Diode laser

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).

980nm wavelength Diode laser

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nourhan M.Aly: lead

Study Sites (1)

Faculty of Dentistry, Alexandria University

Alexandria, Egypt

Location

Study Officials

• Souzy K Anwar, PhD

  Alexandria University

  PRINCIPAL INVESTIGATOR

• Yasmine Y Gaweesh, PhD

  Alexandria University

  STUDY DIRECTOR

• Nourhan M Aly, MSc

  Alexandria University

  STUDY DIRECTOR

• Gillan I El-Kimary, PhD

  Alexandria University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Lecturer of Dental Public Health

Study Record Dates

• First Submitted: December 3, 2023
• First Posted: December 12, 2023
• Study Start: October 1, 2021
• Primary Completion: November 20, 2023
• Study Completion: November 22, 2023
• Last Updated: December 12, 2023

Record last verified: 2023-12

Locations

EG (1)