Gingival Depigmentation Using Diode Laser 940nm Versus 980nm

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

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.

Study Overview

• Status: Completed
• Conditions: Gingival Pigmentation
• Intervention / Treatment: Device: Biolase Epic X 940nm wavelength Diode laser; Device: Doctor smile simpler 980nm wavelength Diode laser

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt
    • Faculty of Dentistry, Alexandria University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 940nm wavelength Diode laser	Device: Biolase 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).
Active Comparator: 980nm wavelength Diode laser	Device: Doctor 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Nourhan M.Aly
• Investigators: Study Chair: Gillan I El-Kimary, PhD, Alexandria University; Principal Investigator: Souzy K Anwar, PhD, Alexandria University; Study Director: Yasmine Y Gaweesh, PhD, Alexandria University; Study Director: Nourhan M Aly, MSc, Alexandria University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2021
• Primary Completion (Actual): November 20, 2023
• Study Completion (Actual): November 22, 2023

Study Registration Dates

• First Submitted: December 3, 2023
• First Submitted That Met QC Criteria: December 3, 2023
• First Posted (Estimated): December 12, 2023

Study Record Updates

• Last Update Posted (Estimated): December 12, 2023
• Last Update Submitted That Met QC Criteria: December 3, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Pigmentation Disorders; Hypopigmentation
• Other Study ID Numbers: 5/23

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No