Evaluation of the Efficacy of Blue Laser in the Management of Gingival Hyperpigmentation Using Contact vs. Non-contact Mode: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Postoperative pain
研究概览
简要总结
The goal of this clinical trial is to compare clinical and digital color parameter results of gingival depigmentation using blue laser in both contact and non- contact modes in patients with physiological gingival hyperpigmentation. The main questions it aims to answer are:
- Which intervention will provide less pain?
- Which intervention will provide better gingival depigmentation?
Participants will undergo:
- Mechanical plaque removal
- Infiltration using Articaine 4%
- Blue diode laser (445 nm) application to the gingiva either from a 2-mm distance in one group or directly to the gingiva in the other group.
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 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with physiological gingival hyperpigmentation.
- •Patients free from systemic diseases or with controlled systemic diseases
- •Age range between 18 and 40
- •Non smokers
排除标准
- •Patients with poor oral hygiene
- •Immunosuppressed patients
- •Patients with uncontrolled systemic diseases
- •Patients having malignancies at the treatment site
- •Patients with photosensitive conditions or on photosensitizing medications
- •Pregnant women
研究组 & 干预措施
Non-contact group
This group underwent gingival depigmentation using blue laser in non-contact mode.
干预措施: Gingival depigmentation using blue laser in non-contact mode (Procedure)
Contact group
This group underwent gingival depigmentation using blue laser in contact mode.
干预措施: Gingival depigmentation using blue laser in contact mode (Procedure)
结局指标
主要结局
Postoperative pain
时间窗: immediately after the procedure, 24 hours post operatively, and 7 days post operatively.
Postoperative pain will be assessed using a 10-cm Visual Analog Scale (VAS), with 0 representing no pain and 10 representing the worst pain imaginable. Participants will record their perceived pain following the laser depigmentation procedure. Unit of measure: Score
Degree of gingival pigmentation
时间窗: 1 and 3 months after completion of the procedure.
Degree of gingival pigmentation was assessed using the Dummett Oral Pigmentation Index (DOPI).
Extent and distribution of gingival pigmentation
时间窗: 1 and 3 months after completion of the procedure.
Extent and distribution of gingival pigmentation were measured using Hedin Melanin Index (HMI)
次要结局
- Changes in gingival color(1 and 3 months after completion of the procedure)
研究者
Sara Hammoud
BDS
Beirut Arab University