Licorice Extract Gel Versus Diode Laser for Physiologic Gingival Pigmentation

NCT ID: NCT07325825

Last Updated: 2026-01-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-01
• Study Completion Date: 2026-01-01

Brief Summary

This randomized controlled clinical trial aims to compare the effectiveness of topical licorice extract gel and diode laser (445 nm) in the treatment of physiologic gingival pigmentation.

Twenty-four adult patients presenting with physiologic melanin pigmentation in the anterior esthetic zone of the maxillary or mandibular gingiva will be randomly allocated into two equal groups. One group will be treated with diode laser therapy, while the other group will receive topical licorice extract gel.

Clinical outcomes will be assessed using standardized gingival pigmentation indices and patient satisfaction questionnaires over a follow-up period of 36 weeks.

Detailed Description

This randomized controlled clinical trial will be conducted at the outpatient clinic of the Department of Oral Medicine, Periodontology, Oral Diagnosis and Oral Radiology, Faculty of Dentistry, Alexandria University, Egypt.

Eligible participants aged 18-50 years with physiologic gingival pigmentation will be randomly assigned into two groups. Group A will receive gingival depigmentation using a 445 nm diode laser, while Group B will receive topical licorice extract gel applied three times daily.

The intensity and distribution of gingival pigmentation will be evaluated using the Dummett-Gupta Oral Pigmentation Index (DOPI) and Gingival Pigmentation Index (GPI). Patient satisfaction will also be assessed. Clinical evaluations will be performed at baseline, 1 week, 4 weeks, 12 weeks and 36 weeks after treatment.

Conditions

Gingival Hyperpigmentation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Diode Laser Group

Participants receive gingival depigmentation using a 445 nm diode laser.

Group Type: ACTIVE_COMPARATOR

Diode Laser 445 nm

Intervention Type: DEVICE

Gingival depigmentation performed using a diode laser with a wavelength of 445 nm in continuous wave mode at 1 W power.

Licorice Extract Gel Group

Participants apply topical licorice extract gel to pigmented gingival areas three times daily.

Group Type: EXPERIMENTAL

Licorice Extract Gel

Intervention Type: DRUG

Topical licorice extract gel applied to pigmented gingival areas three times daily for one month, with continuation for a second and third month if required.

Interventions

Diode Laser 445 nm

Gingival depigmentation performed using a diode laser with a wavelength of 445 nm in continuous wave mode at 1 W power.

Intervention Type: DEVICE

Licorice Extract Gel

Topical licorice extract gel applied to pigmented gingival areas three times daily for one month, with continuation for a second and third month if required.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Adults (18 to 50 years old) of either sex with physiologic melanin pigmentation in the anterior esthetic zone of the maxillary or mandibular gingiva.
• Systemically healthy individuals

Exclusion Criteria

• Smokers
• Pregnant or lactating females
• Patients taking drugs associated with gingival pigmentation
• Patients with periodontal disease
• History of gingival depigmentation
• Known hypersensitivity to licorice extract
• Poor oral hygiene
• Presence of systemic diseases

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alexandria University

OTHER

Sponsor Role: lead

Responsible Party

Rania Mostafa Eissa

Master's degree researcher, department of Oral Medicine and Diagnosis

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Oral Medicine and Diagnosis Clinic, Faculty of Dentistry, Alexandria University

Alexandria, Alexandria Governorate, Egypt

Countries

Egypt

Other Identifiers

RaniaEissa-Dent-1999

Identifier Type: -

Identifier Source: org_study_id