Clinical Trials Directory

Trials / Completed

CompletedNCT07520266

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
Phase
N/A
Study type
Interventional
Enrollment
38 (actual)
Sponsor
Can Tho University of Medicine and Pharmacy · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
DEVICEEr,Cr:YSGG laserThe 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 laserThe 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.

Timeline

Start date
2023-03-01
Primary completion
2024-05-01
Completion
2025-05-01
First posted
2026-04-09
Last updated
2026-04-14

Locations

2 sites across 1 country: Vietnam

Source: ClinicalTrials.gov record NCT07520266. Inclusion in this directory is not an endorsement.