This randomized split-mouth clinical trial will compare the effectiveness of a 940 nm GaAlAs diode laser and a ceramic soft tissue trimmer for the treatment of physiologic gingival melanin pigmentation. Each participant will receive both treatment modalities in separate gingival regions according to a randomized allocation. Changes in gingival pigmentation will be evaluated using clinical pigmentation indices and digital image analysis. Participants will be followed at 1, 3, and 6 months after treatment to assess pigmentation reduction and repigmentation.
Physiologic gingival melanin pigmentation may affect smile aesthetics and may be treated using several depigmentation techniques. This study is designed as a randomized split-mouth clinical trial comparing a 940 nm GaAlAs diode laser (Epic X, BIOLASE) with a ceramic soft tissue trimmer for gingival depigmentation. Eligible participants with physiologic gingival melanin pigmentation will receive both interventions in paired gingival regions. Treatment allocation will be randomized. Clinical and photographic assessments will be performed at baseline and during follow-up visits at 1, 3, and 6 months. Gingival pigmentation will be evaluated based on pigmentation intensity and the extent of pigmented gingival area. The study will also assess the persistence or recurrence of pigmentation during follow-up.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
17
Gingival depigmentation is performed using a 940 nm GaAlAs diode laser (EPIC X, BIOLASE) according to the study protocol.
Gingival depigmentation is performed using a ceramic soft tissue trimmer (NTI) according to the study protocol.
Faculty of Dentistry, University of Medicine and Pharmacy at Ho Chi Minh City
Ho Chi Minh City, Ho Chi Minh City, Vietnam
Change in Dummett Oral Pigmentation Index (DOPI)
Gingival pigmentation intensity is assessed using the Dummett Oral Pigmentation Index (DOPI), scored from 0 to 3: score 0 = no clinical pigmentation, with pink gingiva; score 1 = mild pigmentation, characterized by light-brown gingiva; score 2 = moderate pigmentation, characterized by medium-brown or mixed pink and brown gingiva; and score 3 = heavy pigmentation, characterized by deep-brown or bluish-black gingiva. Higher scores indicate greater gingival pigmentation intensity. DOPI scores are compared between gingival regions treated with the 940 nm diode laser and the ceramic soft tissue trimmer over follow-up.
Time frame: Baseline, 1 month, 3 months, and 6 months after treatment
Change in Pigmented Gingival Area
The pigmented gingival area is quantified from standardized clinical photographs using digital image analysis and expressed as the percentage of the total gingival area showing melanin pigmentation. Changes are compared between the two treatment modalities over follow-up.
Time frame: Baseline, 1 month, 3 months, and 6 months after treatment
Extent of Gingival Pigmentation According to the Ponnaiyan Classification
The extent and distribution of gingival melanin pigmentation are assessed according to the Ponnaiyan classification (2013), which categorizes pigmentation into six types based on the gingival areas involved: Type I, pigmentation limited to the attached gingiva; Type II, pigmentation involving the attached gingiva and interdental papillae; Type III, pigmentation involving the attached gingiva, marginal gingiva, and interdental papillae; Type IV, pigmentation limited to the marginal gingiva; Type V, pigmentation limited to the interdental papillae; and Type VI, pigmentation involving the marginal gingiva and interdental papillae. Changes in Ponnaiyan classification are compared between gingival regions treated with the 940 nm diode laser and the ceramic soft tissue trimmer during follow-up.
Time frame: Baseline, 1 month, 3 months, and 6 months after treatment
Surgical Procedure Time
The duration of each gingival depigmentation procedure is recorded in minutes from the beginning to the completion of treatment for the assigned gingival region.
Time frame: During the surgical procedure
Perioperative Bleeding
Bleeding is assessed during the gingival depigmentation procedure and at 1 day after treatment using the Varghese bleeding scale. Bleeding is scored as follows: score 0 = no bleeding, with the surgical site clean and dry; score 1 = slight oozing, with blood present but not spreading; and score 2 = evident bleeding, with sufficient blood flow to fill the oral cavity. Bleeding scores are compared between gingival regions treated with the 940 nm diode laser and the ceramic soft tissue trimmer.
Time frame: During the surgical procedure and 1 day after treatment
Postoperative Pain
Postoperative pain is assessed using a 10-cm Visual Analogue Scale (VAS), where 0 cm represents no pain and 10.0 cm represents unbearable pain. Pain intensity is categorized as follows: 0 = no pain; 0.1-3.0 cm = mild pain; 3.1-6.0 cm = moderate pain; and 6.1-10.0 cm = severe pain. VAS scores are compared between gingival regions treated with the 940 nm diode laser and the ceramic soft tissue trimmer.
Time frame: 1, 3, and 7 days after treatment
Gingival Epithelialization
Epithelialization of the treated gingival surface is clinically assessed based on the presence and extent of epithelial coverage. Epithelialization is compared between gingival regions treated with the 940 nm diode laser and the ceramic soft tissue trimmer.
Time frame: 3 and 7 days after treatment
Patient Satisfaction
Patient satisfaction with the gingival esthetic treatment outcome is assessed using a 5-point Likert scale ranging from very dissatisfied to very satisfied.
Time frame: 6 months after treatment
Number of Gingival Units With Residual or Recurrent Pigmentation
Gingival Units With Residual or Recurrent Pigmentation The number of gingival units showing residual or recurrent melanin pigmentation is recorded for each treatment modality during follow-up.
Time frame: 1 month, 3 months, and 6 months after treatment
Willingness to Repeat Gingival Esthetic Treatment
Repeat Gingival Esthetic Treatment Participants are asked whether they would be willing to undergo the gingival esthetic procedure again if needed. Responses are recorded as Yes or No.
Time frame: 6 months after treatment
Preferred Treatment Modality
Participants are asked which treatment modality they would prefer if gingival depigmentation were repeated: diode laser or ceramic soft tissue trimmer.
Time frame: 6 months after treatment
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