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

NCT07520266 | Completed DMC

• 1 other identifier: 23.350.HV/PCT-HĐĐĐ
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 2

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.

Conditions

Gingival Hyperpigmentation

Keywords

Er,Cr:YSGG; esthetic dentistry; gingival

Outcome Measures

Primary Outcomes (2)

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

  Assessment of gingival pigmentation using the DOPI score.

  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.

  Baseline, 7 days, 1 month, 3 months

Secondary Outcomes (1)

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

  1 day, 7 days

Other Outcomes (1)

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

  7 days, 1 month

Study Arms (2)

Er,Cr:YSGG

OTHER

This group treated with an erbium chromium-doped: yttrium, scandium, gallium, garnet (Er,Cr:YSGG) laser at 2780 nm

Device: Er,Cr:YSGG laser

Diode

OTHER

This group treated with 940 nm diode laser.

Other: Diode laser

Interventions

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.

Diode

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%.

Er,Cr:YSGG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• all patients exhibiting physiological melanin hyperpigmentation of score 1 or more according to the oral pigmentation index (DOPI) in the buccal maxillary gingiva

You may not qualify if:

• 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.

Sponsors & Collaborators

• Can Tho University of Medicine and Pharmacy: lead

Study Sites (2)

Can Tho University of Medicine and Pharmacy

Can Tho, +84, Vietnam

Location

Can Tho University of Medicine and Pharmacy

Can Tho, 90000, Vietnam

Location

Related Publications (11)

• Torkzaban P, Barati I, Faradmal J, Ansari-Moghadam S, Gholami L. Efficacy of the Er,Cr:YSGG Laser Application Versus the Conventional Method in Periodontal Flap Surgery: A Split-Mouth Randomized Control Trial. J Lasers Med Sci. 2022 Jan 25;13:e4. doi: 10.34172/jlms.2022.04. eCollection 2022.

  PMID: 35642235 RESULT

• Altayeb W, Hamadah O, Alhaffar BA, Abdullah A, Romanos G. Gingival depigmentation with diode and Er,Cr:YSGG laser: evaluating re-pigmentation rate and patient perceptions. Clin Oral Investig. 2021 Sep;25(9):5351-5361. doi: 10.1007/s00784-021-03843-6. Epub 2021 Feb 23.

  PMID: 33624200 RESULT

• Jnaid Harb ZK, El-Sayed W, Alkhabuli J. Gingival Depigmentation Using Diode 980 nm and Erbium-YAG 2940 nm Lasers: A Split-Mouth Clinical Comparative Study. Int J Dent. 2021 Dec 28;2021:9424793. doi: 10.1155/2021/9424793. eCollection 2021.

  PMID: 34992657 RESULT

• Vasyani Y, Gaikwad S, Subhadarsanee C, Shelke A, Durge K. Split-Mouth Comparison of Pain and Healing Associated With the Electrocautery and Bur Abrasion Methods in the Treatment of Depigmentation: A Case Report. Cureus. 2024 May 1;16(5):e59455. doi: 10.7759/cureus.59455. eCollection 2024 May.

  PMID: 38826928 RESULT

• Elavarasu S, Thangavelu A, Alex S. Comparative evaluation of depigmentation techniques in split-mouth design with electrocautery and laser. Journal of pharmacy & bioallied sciences. 2015;7(Suppl 2):S786-90. Epub 2015/11/06. doi: 10.4103/0975-7406.163563. PubMed PMID: 26538970; PubMed Central PMCID: PMCPMC4606712.

  RESULT

• Slominski RM, Sarna T, Plonka PM, Raman C, Brozyna AA, Slominski AT. Melanoma, Melanin, and Melanogenesis: The Yin and Yang Relationship. Front Oncol. 2022 Mar 14;12:842496. doi: 10.3389/fonc.2022.842496. eCollection 2022.

  PMID: 35359389 RESULT

• Jazzar A, AlDehlawi H. Efficacy and Risks of Different Treatments for Oral Hyperpigmentation: A Systematic Review and Network Meta-Analysis. J Clin Med. 2023 Oct 17;12(20):6567. doi: 10.3390/jcm12206567.

  PMID: 37892705 RESULT

• Sreeja C, Ramakrishnan K, Vijayalakshmi D, Devi M, Aesha I, Vijayabanu B. Oral pigmentation: A review. Journal of pharmacy & bioallied sciences. 2015;7(Suppl 2):S403-8. Epub 2015/11/06. doi: 10.4103/0975-7406.163471. PubMed PMID: 26538887; PubMed Central PMCID: PMCPMC4606629.

  RESULT

• Verma J, Ahuja A, Ahuja V, Thosar NR. Reconnoitering the Association of Gingival Melanin Pigmentation With Skin Color, Age, and Sex in Pre-School Children of Hazaribag: A Cross-Sectional Study. Cureus. 2022 Oct 26;14(10):e30699. doi: 10.7759/cureus.30699. eCollection 2022 Oct.

  PMID: 36439562 RESULT

• Gholami L, Moghaddam SA, Rigi Ladiz MA, Molai Manesh Z, Hashemzehi H, Fallah A, Gutknecht N. Comparison of gingival depigmentation with Er,Cr:YSGG laser and surgical stripping, a 12-month follow-up. Lasers Med Sci. 2018 Nov;33(8):1647-1656. doi: 10.1007/s10103-018-2501-1. Epub 2018 Apr 13.

  PMID: 29654420 RESULT

• 1. Abati S, Sandri GF, Finotello L, Polizzi E. Differential Diagnosis of Pigmented Lesions in the Oral Mucosa: A Clinical Based Overview and Narrative Review. 2024;16(13):2487. PubMed PMID: doi:10.3390/cancers16132487.

  RESULT

MeSH Terms

Interventions

Lasers, Semiconductor

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 7, 2025
• First Posted: April 9, 2026
• Study Start: March 1, 2023
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2025
• Last Updated: April 14, 2026

Record last verified: 2026-04

Locations

VN (2)