Influence of Adjunctive Acids Use on Esthetic Outcomes of Gingival Melanin Depigmentation: A Periodontal-Operative Pilot 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
- 30
- 主要终点
- Esthetic Outcome of Gingival Melanin Depigmentation
研究概览
简要总结
This pilot randomized clinical trial aims to evaluate the effect of adjunctive acid application on the esthetic outcomes of gingival melanin depigmentation. Participants with physiologic gingival hyperpigmentation will be randomly assigned to receive conventional gingival depigmentation with or without adjunctive acid application. The primary outcome is the improvement in gingival esthetics, while secondary outcomes include postoperative healing, pain, patient satisfaction, and recurrence of pigmentation. The findings of this study may help identify whether adjunctive acid application improves the clinical outcomes of gingival depigmentation procedures.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18-50 years.
- •Presence of physiologic gingival melanin pigmentation requiring treatment.
- •Good general health.
- •Good periodontal health or a healthy periodontium after initial periodontal therapy.
- •Willingness to participate and provide written informed consent.
- •Ability to attend all follow-up visits.
排除标准
- •Current smokers or tobacco users.
- •Pregnancy or breastfeeding.
- •History of systemic diseases that may affect wound healing (e.g., uncontrolled diabetes or immunocompromised conditions).
- •Use of medications known to affect gingival pigmentation or wound healing.
- •Previous gingival depigmentation treatment in the study area.
- •Active periodontal disease or oral infection. Known allergy or hypersensitivity to the study acid or related materials.
结局指标
主要结局
Esthetic Outcome of Gingival Melanin Depigmentation
时间窗: 3 months after treatment
Assessment of the esthetic improvement following gingival melanin depigmentation with or without adjunctive acid application using the study's predefined esthetic evaluation method.
次要结局
未报告次要终点