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| ID | Type | Description | Link |
|---|---|---|---|
| 23.350.HV/PCT-HĐĐĐ | Other Identifier | Can Tho University of Medicine and Pharmacy |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Er,Cr:YSGG | Other | This group treated with an erbium chromium-doped: yttrium, scandium, gallium, garnet (Er,Cr:YSGG) laser at 2780 nm |
|
| Diode | Other | This group treated with 940 nm diode laser. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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%. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in postoperative pain measured by Visual Analog Scale (VAS) | Pain intensity assessed using the Visual Analog Scale (VAS) ranging from 0 to 10 | 1 day, 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change in wound healing assessed by Landry, Turnbull and Howley Healing Index Healing assessed using Landry, Turnbull and Howley index | Wound healing evaluated using the Landry, Turnbull and Howley Healing Index, scored from 1 to 5 | 7 days, 1 month |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Can Tho University of Medicine and Pharmacy | Can Tho | +84 | Vietnam | |||
| Can Tho University of Medicine and Pharmacy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35642235 | Result | 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. | |
| 33624200 | Result |
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| ID | Term |
|---|---|
| D054023 | Lasers, Semiconductor |
| ID | Term |
|---|---|
| D007834 | Lasers |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |
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| 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. |
|
| Can Tho |
| 90000 |
| Vietnam |
| 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. |
| 34992657 | 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. |
| 38826928 | 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. |
| 26538970 | Result | 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. |
| 35359389 | 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. |
| 37892705 | 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. |
| 26538887 | Result | 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. |
| 36439562 | 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. |
| 29654420 | 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. |
| 39001549 | Result | 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. |