Gingival Depigmentation Using Diode Laser 940nm Versus 980nm

Gingival Pigmentation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06167148
• Other study ID #: 5/23
• Status: Completed
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: November 22, 2023

Study information

• Verified date: December 2023
• Source: University of Alexandria
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 22, 2023
• Est. primary completion date: November 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Gingival Pigmentation
• Hypopigmentation

Intervention

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).
• 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).

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry, Alexandria University	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Nourhan M.Aly

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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