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Gingival HyperpigmentationLaserNCT07520266

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

A study testing Er,Cr:YSGG laser and Diode laser in people with Gingival Hyperpigmentation, run by Can Tho University of Medicine and Pharmacy at 2 sites in Vietnam.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Gingival Hyperpigmentation
What is being tested?
Er,Cr:YSGG laser and Diode laser
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
2 sitesVietnam
Study dates
1 Mar 2023to 1 May 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country.

Vietnam2 sites

  • Can Tho University of Medicine and Pharmacy

    Can Tho, +84

  • Can Tho University of Medicine and Pharmacy

    Can Tho, 90000

Other trials in Vietnam

About this study

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

Read the 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.

Being tested
Er,Cr:YSGG laser, Diode laser
Keywords
Er,Cr:YSGG, esthetic dentistry, gingival

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT07520266
Study groupRoleWhat they receive
Er,Cr:YSGGOtherThis group treated with an erbium chromium-doped: yttrium, scandium, gallium, garnet (Er,Cr:YSGG) laser at 2780 nm
Receives: Device: Er,Cr:YSGG laser
DiodeOtherThis group treated with 940 nm diode laser.
Receives: Other: Diode laser

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Assessment of gingival pigmentation using the DOPI score.

    Measured: Baseline, 7 days, 1 month, 3 months

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

    Assessment of gingival pigmentation using the MPI score.

    Measured: Baseline, 7 days, 1 month, 3 months

Secondary outcomes (1)

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

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

    Measured: 1 day, 7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Apr 2026
  2. Study start1 Mar 2023
  3. Primary completion1 May 2024
  4. Study completion1 May 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07520266
Sponsor's protocol ID
23.350.HV/PCT-HĐĐĐ
Other IDs
23.350.HV/PCT-HĐĐĐ
Acronym
Laser
Status last verified
Apr 2026
First submitted
7 Sep 2025
Last updated
14 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 35642235

  • 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.

    PubMed 33624200

  • 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.

    PubMed 34992657

  • 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.

    PubMed 38826928

  • Elavarasu S, Thangavelu A, Alex S. Comparative evaluation of depigmentation techniques in split-mouth design with electrocautery and laser. J Pharm Bioallied Sci. 2015 Aug;7(Suppl 2):S786-90. doi: 10.4103/0975-7406.163563.

    PubMed 26538970

  • 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.

    PubMed 35359389

  • 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.

    PubMed 37892705

  • Sreeja C, Ramakrishnan K, Vijayalakshmi D, Devi M, Aesha I, Vijayabanu B. Oral pigmentation: A review. J Pharm Bioallied Sci. 2015 Aug;7(Suppl 2):S403-8. doi: 10.4103/0975-7406.163471.

    PubMed 26538887

  • 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.

    PubMed 36439562

  • 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.

    PubMed 29654420

  • Abati S, Sandri GF, Finotello L, Polizzi E. Differential Diagnosis of Pigmented Lesions in the Oral Mucosa: A Clinical Based Overview and Narrative Review. Cancers (Basel). 2024 Jul 8;16(13):2487. doi: 10.3390/cancers16132487.

    PubMed 39001549

Questions about this trial

What is this clinical trial studying?

A study testing Er,Cr:YSGG laser and Diode laser in people with Gingival Hyperpigmentation, run by Can Tho University of Medicine and Pharmacy at 2 sites in Vietnam.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in gingival pigmentation measured by Dummett-Gupta Oral Pigmentation Index (DOPI) (time frame: Baseline, 7 days, 1 month, 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07520266, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.

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