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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
26
Gingival depigmentation performed using a diode laser with a wavelength of 445 nm in continuous wave mode at 1 W power.
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.
Oral Medicine and Diagnosis Clinic, Faculty of Dentistry, Alexandria University
Alexandria, Alexandria Governorate, Egypt
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.
Time frame: 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).
Time frame: Baseline, 1 week, 4 weeks, 12 weeks and 36 weeks
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.
Time frame: 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.
Time frame: Immediately post-procedure, Day 1 and Day 7 postoperatively
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.