Comparison of Gingival Depigmentation Using a 940 nm GaAlAs Diode Laser and Ceramic Bur: A Split-Mouth Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Change in Dummett Oral Pigmentation Index (DOPI)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The outcomes assessor is blinded to the intervention allocation and is not involved in the treatment procedures.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Laser group
Gingival depigmentation is performed in one randomly assigned gingival region using a 940 nm GaAlAs diode laser (EpicX, Biolase).
干预措施: 940 nm GaAlAs Diode Laser (Device)
Ceramic Bur Group
Gingival depigmentation is performed in the contralateral gingival region using a ceramic soft tissue trimmer (NTI).
干预措施: Ceramic Soft Tissue Trimmer (Device)
结局指标
主要结局
Change in Dummett Oral Pigmentation Index (DOPI)
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Surgical Procedure Time(During the surgical procedure)
- Perioperative Bleeding(During the surgical procedure and 1 day after treatment)
- Postoperative Pain(1, 3, and 7 days after treatment)
- Gingival Epithelialization(3 and 7 days after treatment)
- Patient Satisfaction(6 months after treatment)
- Number of Gingival Units With Residual or Recurrent Pigmentation(1 month, 3 months, and 6 months after treatment)
- Willingness to Repeat Gingival Esthetic Treatment(6 months after treatment)
- Preferred Treatment Modality(6 months after treatment)
研究者
Huy Gia Ho
Postgraduate Resident, Department of Periodontics, Faculty of Dentistry
University of Medicine and Pharmacy at Ho Chi Minh City