Gingival Depigmentation With Diode and Er,Cr:YSGG Laser: A Split-mouth Trial

N/ACompletedNCT07520266

Can Tho University of Medicine and Pharmacy38 enrolled

Overview

Gingival hyperpigmentation is a common physiological condition caused by excessive melanin deposition in oral mucosa, negatively affecting smile esthetics. Laser therapy has become an effective treatment option due to advantages such as minimal bleeding, reduced postoperative discomfort, and faster healing. This clinical study aims to evaluate clinical characteristics of gingival pigmentation and compare treatment outcomes between diode laser and Er,Cr:YSGG laser techniques. Outcomes include pigmentation reduction, postoperative pain, wound healing, bleeding, patient satisfaction, and recurrence rate.

Gingival depigmentation is widely performed to improve smile esthetics in patients with excessive melanin pigmentation. Various treatment modalities have been proposed, including scalpel surgery, electrosurgery, cryotherapy, and laser therapy. Among these, diode laser and Er,Cr:YSGG laser have demonstrated promising results due to selective absorption by pigmented tissues and minimal tissue trauma. This interventional clinical study compares two laser systems for treatment of gingival pigmentation. Clinical indices such as DOPI (Dummett-Gupta Oral Pigmentation Index), MPI (Melanin Pigmentation Index), postoperative pain (VAS scale), bleeding, wound healing (Landry index), and patient satisfaction will be evaluated at multiple follow-up time points including baseline, 1 day, 7 days, 1 month, and 3 months. The study aims to determine the more effective laser modality in improving esthetic outcomes and minimizing complications.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Interventions

Er,Cr:YSGG laserDEVICE

The group Er,Cr:YSGG (2780 nm) has a wavelength of 2780 nm, a pulse duration of 140-150 microseconds, a power output of 2.5W, a steam content of 11%, and a water content of 30%.

Diode laserOTHER

The Group Laser Diode (940 nm) has a wavelength of 940 to 10 nm, a pulse length of 15 microseconds, and a power output of 2.5 W. Activate the fiber laser head by touching the tip to the colored paper.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * all patients exhibiting physiological melanin hyperpigmentation of score 1 or more according to the oral pigmentation index (DOPI) in the buccal maxillary gingiva Exclusion Criteria: * history of systemic diseases related to pathology * participants with a systemic condition that could affect tissue healing (e.g., uncontrolled diabetes, autoimmune diseases, HIV, leukemia, etc.) * pregnancy and lactation * a history of smoking; previously used drugs (related to pigmentation) before the intervention within the last 6 months * contraindication for laser treatment.

Outcomes

Primary Outcomes

Change in gingival pigmentation measured by Dummett-Gupta Oral Pigmentation Index (DOPI)

Assessment of gingival pigmentation using the DOPI score.

Time frame: Baseline, 7 days, 1 month, 3 months

Change in gingival pigmentation measured by Melanin Pigmentation Index (MPI)

Assessment of gingival pigmentation using the MPI score.

Time frame: Baseline, 7 days, 1 month, 3 months

Secondary Outcomes

Change in postoperative pain measured by Visual Analog Scale (VAS)

Pain intensity assessed using the Visual Analog Scale (VAS) ranging from 0 to 10

Time frame: 1 day, 7 days