Randomized Clinical Trial on the Effect of Intermittent Vibrational Force Application During Orthodontic Treatment With Aligners on RANKL and OPG Concentrations in Crevicular Fluid
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- OPG concentration Baseline
研究概览
简要总结
This three-arm cross-over randomized clinical trial (allocation ratio of 1:1:1) will aim to explore whether the application of intermittent vibratory forces modify RANKL and OPG concentrations in patients undergoing orthodontic treatment with clear aligners. The specific objective will be to compare gingival crevicular fluid concentrations of RANKL and OPG among groups according to the application or not of Acceledent® treatment at different time points and frequencies of aligner changes.
详细描述
Application of intermittent forces by vibration is supposed to be an easy-to-use accelerator of dental movement. The purpose of this study is to determine the effect of intermittent vibrational force application during orthodontic aligner treatment on RANKL and OPG concentrations in crevicular fluid as markers of bone remodelling. This randomized clinical trial will include candidates for malocclusion treatment with aligners, randomly assigned to 3 groups: group A, vibrational forces from onset of treatment; group B, vibrational forces at 6 weeks after treatment onset; and group C, no vibration (controls). The frequency of aligner adjustment will also differ among groups and measurement time points. At different time points, a paper tip will be used to draw crevicular fluid samples from a moving lower incisor for RANKL and OPG analysis using ELISA kits.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients in need of treatment of malocclusion with Invisalign® (Align Technology, San Jose, CAL) using at least 14 sets of aligners
- •patients with good general health
排除标准
- •smoking habit, poor oral hygiene, the presence of periodontal disease or any other chronic or systemic diseases that could affect bone metabolism or inflammation and the previous or current receipt of medications that could influence bone metabolism (e.g., bisphosphonates).
结局指标
主要结局
OPG concentration Baseline
时间窗: Baseline
Gingival crevicular fluid concentrations of OPG at baseline
RANKL concentration at 18 weeks
时间窗: 18 weeks
Gingival crevicular fluid concentrations of RANKL at 18 weeks
RANKL concentration at 6 weeks
时间窗: 6 weeks
Gingival crevicular fluid concentrations of RANKL at 6 weeks
OPG concentration at 6 weeks
时间窗: 6 weeks
Gingival crevicular fluid concentrations of OPG at 6 weeks
OPG concentration at 18 weeks
时间窗: 18 weeks
Gingival crevicular fluid concentrations of OPG at 18 weeks
RANKL concentration Baseline
时间窗: Baseline
Gingival crevicular fluid concentrations of RANKL at baseline
RANKL concentration at 12 weeks
时间窗: 12 weeks
Gingival crevicular fluid concentrations of RANKL at 12 weeks
OPG concentration at 12 weeks
时间窗: 12 weeks
Gingival crevicular fluid concentrations of OPG at 12 weeks
次要结局
- Plaque index(Baseline and 18 weeks)
- Orthodontic tooth movement achieved(Baseline and 18 weeks)
- Bleeding on probing index(Baseline and 18 weeks)
- Gingival index(Baseline and 18 weeks)