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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07520266
Acronym
Laser
Enrollment
38
Registered
2026-04-09
Start date
2023-03-01
Completion date
2025-05-01
Last updated
2026-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gingival Hyperpigmentation

Keywords

Er,Cr:YSGG, esthetic dentistry, gingival

Brief summary

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.

Detailed description

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.

Interventions

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%.

OTHERDiode laser

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.

Sponsors

Can Tho University of Medicine and Pharmacy
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in gingival pigmentation measured by Dummett-Gupta Oral Pigmentation Index (DOPI)Baseline, 7 days, 1 month, 3 monthsAssessment of gingival pigmentation using the DOPI score.
Change in gingival pigmentation measured by Melanin Pigmentation Index (MPI)Baseline, 7 days, 1 month, 3 monthsAssessment of gingival pigmentation using the MPI score.

Secondary

MeasureTime frameDescription
Change in postoperative pain measured by Visual Analog Scale (VAS)1 day, 7 daysPain intensity assessed using the Visual Analog Scale (VAS) ranging from 0 to 10

Countries

Vietnam

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 15, 2026