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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diode Laser Group | Active Comparator | Participants receive gingival depigmentation using a 445 nm diode laser. |
|
| Licorice Extract Gel Group | Experimental | Participants apply topical licorice extract gel to pigmented gingival areas three times daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diode Laser 445 nm | Device | Gingival depigmentation performed using a diode laser with a wavelength of 445 nm in continuous wave mode at 1 W power. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in gingival pigmentation intensity | Degree of gingival pigmentation assessed using the Dummett-Gupta Oral Pigmentation Index (DOPI; scores range from 0 to 3), with higher scores indicating increased pigmentation intensity. | Baseline, 1 week, 4 weeks, 12 weeks and 36 weeks |
| Change in gingival pigmentation distribution | Gingival pigmentation distribution was assessed using the Gingival Pigmentation Index (GPI). The GPI is an ordinal scale ranging from 0 to 3, where 0 indicates absence of pigmentation and 3 indicates widespread gingival pigmentation. Higher scores represent greater extent of gingival pigment distribution (worse pigmentation). | Baseline, 1 week, 4 weeks, 12 weeks and 36 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Participant Satisfaction | Participant satisfaction was assessed using a study-specific questionnaire consisting of four questions evaluating perceived esthetic improvement, fulfillment of expectations, self-confidence related to smile appearance, and willingness to recommend the treatment. Responses were recorded as categorical (non-numerical) variables, and no numerical scale was calculated. Outcomes were analyzed descriptively, with more favorable responses indicating higher satisfaction. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oral Medicine and Diagnosis Clinic, Faculty of Dentistry, Alexandria University | Alexandria | Alexandria Governorate | 21526 | Egypt |
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| ID | Term |
|---|---|
| D054023 | Lasers, Semiconductor |
| ID | Term |
|---|---|
| D007834 | Lasers |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |
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intervention (control group): Diode laser 445 nm intervention (test group): topical licorice extract gel
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| Licorice Extract Gel | 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. |
|
| 3 months post-treatment |
| Postoperative pain intensity (laser group only) | Postoperative pain intensity was assessed in the diode laser group only using the Visual Analog Scale (VAS; range 0-10), where 0 indicates no pain and 10 indicates the worst imaginable pain. This outcome was not applicable to the licorice extract gel group due to the non-invasive nature of the intervention. | Immediately post-procedure, Day 1 and Day 7 postoperatively |