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Completed

NCT Number: NCT07520266

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

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.

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Key information

Conditions

Gingival Hyperpigmentation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Can Tho University of Medicine and Pharmacy, Can Tho, Vietnam

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Er,Cr:YSGG Laser

Device

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 laser

Other

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.

Primary outcomes

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

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

    Assessment of gingival pigmentation using the DOPI score.

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

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

    Assessment of gingival pigmentation using the MPI score.

Secondary outcomes

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

    Time frame: 1 day, 7 days

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

Other outcomes

  1. Change in wound healing assessed by Landry, Turnbull and Howley Healing Index Healing assessed using Landry, Turnbull and Howley index

    Time frame: 7 days, 1 month

    Wound healing evaluated using the Landry, Turnbull and Howley Healing Index, scored from 1 to 5

Sponsors and collaborators

Lead sponsor

Can Tho University of Medicine and Pharmacy

Other

Registry information

Official study title

Comparison of Diode and Er,Cr:YSGG Lasers in Gingival Depigmentation: a Split-mouth Randomized Trial

Acronym: Laser

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Apr 9, 2026
Registry last updated
Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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