Gingival Depigmentation Using Diode Laser 940nm Versus 980nm

Not Applicable

Completed

• Conditions: Gingival Pigmentation
• Interventions: Device: Biolase Epic X 940nm wavelength Diode laser; Device: Doctor smile simpler 980nm wavelength Diode laser

• Registration Number: NCT06167148
• Lead Sponsor: Nourhan M.Aly

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-01
• Primary Completion: 2023-11-20
• Study Completion: 2023-11-22
• Status Verified: 2023-12
• Study First Submitted: 2023-12-03
• Study First Submitted QC: 2023-12-03
• Last Update Submitted: 2023-12-03
• Study First Posted: 2023-12-12
• Last Update Posted: 2023-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
940nm wavelength Diode laser	Biolase Epic X 940nm wavelength Diode laser	-
980nm wavelength Diode laser	Doctor smile simpler 980nm wavelength Diode laser	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Faculty of Dentistry, Alexandria University; 🇪🇬 Alexandria, Egypt