Comparison of Surgical Stripping and Erbium, Chromium:Yttrium-scandium-gallium-garnet (Er,Cr:YSGG) Laser Techniques for Gingival Depigmentation Recurrence: A Randomized Clinical Trial, Four Years Follow up
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 主要终点
- Oral pigmentation index (DOPI)
研究概览
简要总结
The appearance and health of the gingiva significantly contribute to an aesthetically pleasing smile. Pink gingiva indicates healthy gums and is generally preferred over dark or mixed colors. However, gingival color varies among individuals based on factors such as race, geography, gum health, epithelial thickness, vascular supply, keratinization level, and pigments in the epithelium layers.
Four primary pigments define mucosa color: melanin, oxygenated hemoglobin (Hb), carotenoids, and reduced Hb. Melanin notably affects excessive gingival pigmentation. Gingival melanin hyperpigmentation, sometimes called racial pigmentation, is a genetic trait present in many ethnic groups due to excess melanin deposition in the epithelial layers. While not a medical concern, this hyperpigmentation can be unattractive, especially for those with a gummy smile. As a result, many seek treatments to reduce or eliminate this pigmentation.
Various methods for gingival depigmentation exist, including surgical scraping, scalpel technique, bur abrasion, free gingival graft, gingivectomy, cryosurgery, electrosurgery, chemical treatments, and lasers. A significant challenge with these treatments is gingival repigmentation or the reappearance of melanin post-procedure.
For years, the scalpel technique was the standard. It's a straightforward and economical method that involves removing the gingival epithelium and some underlying tissue. Although it promotes quick healing, the procedure can cause bleeding, necessitating local anesthesia and post-operative dressings. Due to the associated discomfort, researchers have sought equally effective alternatives.
Laser ablation has become a popular choice among dental professionals and patients. Lasers like carbon dioxide (CO2), diode, argon, ruby, Nd:YAG (neodymium-doped yttrium aluminum garnet) , and Er:YAG (erbium-doped yttrium aluminium garnet) have been proven effective through numerous studies. Lasers present benefits such as minimal post-operative pain, ease of use, and quicker treatment times. Recurrence rates post-laser surgery (1.16%) are lower than with the scalpel technique (4.25%). However, lasers also have downsides, including high costs, potential for thermal damage, and the risk of deep penetration.
One laser, the Erbium-chromium:yttrium-scandium-gallium-garnet (Er,Cr:YSGG), has been FDA-approved for certain dental procedures but hasn't been widely used for gingival depigmentation. Preliminary findings suggest it offers advantages like reduced pain and faster healing compared to other lasers. In a case study involving two patients, the Er,Cr:YSGG laser effectively removed gingival pigmentation, with no recurrence observed after six months.
This clinical trial aimed to compare the efficacy and recurrence rates between the conventional scalpel technique and the Er,Cr:YSGG laser technique. The hypothesis suggests that the Er,Cr:YSGG laser might be a superior treatment for gingival hyperpigmentation compared to other methods.
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)
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Over 18 years of age
- •Periodontally healthy subjects with concerns about their esthetics and presence of gingival hyperpigmentation in the upper arch
排除标准
- •(1) smokers or were previous smokers
- •(2) had a systemic disease/condition,
- •(3) were pregnant/lactating
- •(4) had gingivitis, periodontitis or any other periodontal disease
- •(5) acquired amalgam pigmentation were excluded from the study
结局指标
主要结局
Oral pigmentation index (DOPI)
时间窗: Pre surgical, 1 month post op, 12 months post op
This index of oral pigmentation is the commonly used index due to its simplicity and ease of use. The scores are as follows: 0 = No clinical pigmentation (pink-colored gingiva) 1. Mild clinical pigmentation (mild light brown color) 2. Moderate clinical pigmentation (medium brown or mixed pink and brown color) 3. Heavy clinical pigmentation (deep brown or bluish black color)
Gingival melanosis record (GMR)
时间窗: Pre surgical, 1 month post op, 12 months post op
A quantitative analysis method using clinical oral photographs
次要结局
未报告次要终点
研究者
Talal Zahid
Chairman of Periodontology Department
King Abdulaziz University
