Physiologic Gingival Melanin Pigmentation
Conditions
Keywords
Gingival depigmentation, Gingival melanin pigmentation, Diode laser, Ceramic soft tissue trimmer, Split-mouth randomized clinical trial
Brief summary
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.
Detailed description
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.
Interventions
Gingival depigmentation is performed using a 940 nm GaAlAs diode laser (EPIC X, BIOLASE) according to the study protocol.
DEVICECeramic Soft Tissue Trimmer
Gingival depigmentation is performed using a ceramic soft tissue trimmer (NTI) according to the study protocol.
Sponsors
University of Medicine and Pharmacy at Ho Chi Minh City
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The outcomes assessor is blinded to the intervention allocation and is not involved in the treatment procedures.
Intervention model description
This study uses a randomized split-mouth design. Each participant receives both interventions in paired contralateral gingival regions. One region is randomly assigned to treatment with a 940 nm diode laser, while the contralateral region is treated with a ceramic soft tissue trimmer.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Aged 18 years or older. * Periodontal health, with gingival index (GI) ≤1, bleeding on probing (BOP) ≤10%, probing depths ≤3 mm, and no periodontitis. * Thick gingival phenotype with moderate to severe physiologic melanin pigmentation, corresponding to DOPI scores of 2-3, affecting the facial gingiva of the anterior and premolar regions bilaterally. * Good oral hygiene, with plaque index (PI) ≤1 and calculus index (CI) ≤1.
Exclusion criteria
* Thin gingival phenotype at the treatment sites. * Uncontrolled systemic diseases, including cardiovascular disease, hypertension, or diabetes mellitus. * Pregnancy or lactation. * Use of medications or presence of conditions affecting hemostasis or wound healing. * Oral pigmentation attributable to causes other than physiologic melanin pigmentation, including metallic pigmentation, amalgam tattoo, traumatic tattoo, or pigmentation associated with malignant conditions. * Use of medications or chemical agents known to induce oral pigmentation, including antimalarial drugs, minocycline, ketoconazole, or oral contraceptives. * Current smoking.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Dummett Oral Pigmentation Index (DOPI) | Baseline, 1 month, 3 months, and 6 months after treatment | 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. |
| Change in Pigmented Gingival Area | Baseline, 1 month, 3 months, and 6 months after treatment | 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. |
| Extent of Gingival Pigmentation According to the Ponnaiyan Classification | Baseline, 1 month, 3 months, and 6 months after treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Surgical Procedure Time | During the surgical procedure | The duration of each gingival depigmentation procedure is recorded in minutes from the beginning to the completion of treatment for the assigned gingival region. |
| Perioperative Bleeding | During the surgical procedure and 1 day after treatment | 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. |
| Postoperative Pain | 1, 3, and 7 days after treatment | 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. |
| Gingival Epithelialization | 3 and 7 days after treatment | 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. |
| Patient Satisfaction | 6 months after treatment | Patient satisfaction with the gingival esthetic treatment outcome is assessed using a 5-point Likert scale ranging from very dissatisfied to very satisfied. |
| Number of Gingival Units With Residual or Recurrent Pigmentation | 1 month, 3 months, and 6 months after treatment | 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. |
| Willingness to Repeat Gingival Esthetic Treatment | 6 months after 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. |
| Preferred Treatment Modality | 6 months after treatment | Participants are asked which treatment modality they would prefer if gingival depigmentation were repeated: diode laser or ceramic soft tissue trimmer. |
Countries
Vietnam
Contacts
CONTACTHuy Gia Ho, DDS
Outcome results
None listed