Comparative Evaluation of Laser assisted Ablative Versus Non-ablative Gingival Depigmentation : A Rabdomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- clinician reported outcomes (Dummet-Gupta oral pigmentation Index, Melanin Index, Gingival Pigmentation Index
研究概览
简要总结
The present split-mouth, prospective, single-centered, parallel group, non-placebo control, double- blinded (investigator and observer) simple randomized comparative clinical trial was conducted in the Department of Periodontology, Saraswati Dental College and Hospital, Lucknow, between April 2023 to December 2024. The study design and protocol were conducted in accordance with ethical principles laid down in Helsinki declaration 1998 revised 2013. After approval from Institutional Research and Development Committee (SDC/IRDC/2022/MDS/13) and Institutional Human Ethical Committee (SDC&H/IHEC/2022/MDS/13), all the participants were informed about the study and written informed consent were obtained from the patients in patient’s vernacular language.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- All
入选标准
- •18 to 35 years of age.
排除标准
- •1.The gingival hyperpigmentation that is secondary as a result of a systemic/ congenital condition/ disorder e.g. McCune Albright syndrome, Hutchinson Gilford Progeria Syndrome, Dyskeratosis congentia, Familial Progressive hyperpigmentation etc.
- •Participants with gingival hyperpigmentation due to the use of medications e.
- •tetracycline.
- •Participants who were chronic smokers (self-reported)
- •Participants contraindicated for laser therapy (with phototoxicity, oral malignancy).
结局指标
主要结局
clinician reported outcomes (Dummet-Gupta oral pigmentation Index, Melanin Index, Gingival Pigmentation Index
时间窗: Baseline, 1 week, 1 month and 3 months.
次要结局
- Patient Post Surgical Discomfort Score, Patient Satisfaction Score, Patient Esthetic Score(Baseline, 1 week, 1 month and 3 month)
- Patient Post Surgical Discomfort Score (PPSDS), Patient Esthetic Score (PES), Patient Satisfaction Score (PSS)(PPSDS- 24 hours after intervention)
研究者
Shruti Singh
Saraswati Dental College and Hospital