Gingival Depigmentation With Er,Cr:YSGG and Diode Laser: Randomized Clinical Trial to Evaluate the Repigmentation and Patient Perceptions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Gingival Appearance
研究概览
简要总结
This randomized clinical trial evaluated the recurrence rates of physiological gingival pigments during 24 months follow-up and the patient perceptions after the ablative depigmentation using two laser wavelengths; Diode 940 nm and Er,Cr:YSGG 2780 nm.
详细描述
This study aim to compare the clinical outcomes, the rate of repigmentation, and the patient perceptions after laser-assisted gingival depigmentation with diode 940 nm and Erbium, chromium-doped yttrium, scandium, gallium and garnet (Er,Cr:YSGG) 2780 nm. Two pigmentation index were used to compare between the treatment outcomes of using Diode laser or Er,Cr:YSGG.
The depigmentation procedure essentially involves ablation of epithelial layer of buccal gingiva containing melanin pigmentation.
Sixty healthy patients (22 males and 38 females, aged 21 to 43 years) who presented with a chief complaint of having dark-brown to black gingival hyperpigmentation between April 2015 and September 2018. Participants were randomly divided into 2 groups (30 patients each). Randomization was carried out using randomization table; by a computer-generated randomization list (SPSS v23.0) with allocation ratio 1:1.
All of the patients were selected according to the study inclusion and exclusion criteria.
Data collection was done by a dental specialist who was blinded about the provided treatment. Data collections included the clinical examination at baseline and follow up appointments. To achieve blinding, three calibrated external experts, blinded to the provided treatment classified the degree of gingival pigments and gingival topography according oral pigmentation index (DOPI) and melanin pigmentation index.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Allocation of the patients into the two treatment groups was carried out using randomization table with allocation ratio 1:1.
Participants, investigator, the tree external clinical examiners were blinded about the allocation of the patient in the treatment group.
Care provider didn't interfere in collecting and analysing the data.
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All patient exhibiting physiologic pigmentation of score2 or more according to Oral pigmentation index (DOPI)
排除标准
- •Pathologic hyperpigmentation
- •Participants with a systemic condition that could affect tissue healing (e. g., autoimmune diseases)
- •Pregnancy and lactation
- •History of smoking
- •Previous mucogingival surgery at the region to be treated
- •No contraindication for the laser treatment.
结局指标
主要结局
Gingival Appearance
时间窗: 1 month
* Score 1:Pink vital appearance for the gingiva * Score 2: Pale Non-vital appearance for gingiva
Melanin pigmentation index:
时间窗: 2 years follow-up
* Score 0: No pigmentation * Score 1: Solitary unit(s) of pigmentation in papillary gingiva without extension between neighboring solitary units * Score 2: Formation of continuous ribbon extending from neighboring solitary units
Oral pigmentation index (DOPI)
时间窗: 2 years follow-up
* Score 1: No clinical pigmentation (pink-colored gingiva) * Score 2: Mild clinical pigmentation (mild light brown color) * Score 3: Moderate clinical pigmentation (medium brown or mixed pink and brown color) * Score 4: Heavy clinical pigmentation (deep brown or bluish black color)
次要结局
- Oral Hygiene Index(1 month post-operative)
- Gingival Index(1 month post-operative)