Gingival Depigmentation Using Diode Laser 940nm Versus 980nm

NCT ID: NCT06167148

Last Updated: 2023-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-01

Study Completion Date

2023-11-22

Brief Summary

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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

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Conditions

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Gingival Pigmentation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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940nm wavelength Diode laser

Group Type EXPERIMENTAL

Biolase Epic X 940nm wavelength Diode laser

Intervention Type 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).

980nm wavelength Diode laser

Group Type ACTIVE_COMPARATOR

Doctor smile simpler 980nm wavelength Diode laser

Intervention Type 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).

Interventions

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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).

Intervention Type 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).

Intervention Type DEVICE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nourhan M.Aly

OTHER

Sponsor Role lead

Responsible Party

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Nourhan M.Aly

Assistant Lecturer of Dental Public Health

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Souzy K Anwar, PhD

Role: PRINCIPAL_INVESTIGATOR

Alexandria University

Yasmine Y Gaweesh, PhD

Role: STUDY_DIRECTOR

Alexandria University

Nourhan M Aly, MSc

Role: STUDY_DIRECTOR

Alexandria University

Gillan I El-Kimary, PhD

Role: STUDY_CHAIR

Alexandria University

Locations

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Faculty of Dentistry, Alexandria University

Alexandria, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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5/23

Identifier Type: -

Identifier Source: org_study_id