Localized Piezoelectric Alveolar Decortication With Customized Orthodontic Treatment in Adults: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 主要终点
- Overall treatment time measurement (in days)
研究概览
简要总结
The aim of the present randomized controlled clinical trial will compare Insignia orthodontic treatment to piezocision-assisted Insignia orthodontics in adult patients. The primary objective will be to determine the efficacy of piezocision-accelerated orthodontic treatment by measuring the treatment duration in both groups. The secondary objectives will be to compare periodontal health, alveolar crest changes, bone and gingival healing, analgesic intake and patient-centered outcomes between the 2 groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients requiring maxillary and mandible orthodontic treatment (both arches)
- •Adult patients with completed growth based on the cervical vertebral maturation method as described by Baccetti et al. (Baccetti et al. 2002)
- •Minimal to moderate maxillary and mandibular anterior crowding at baseline (irregularity index <6;(Little 1975));
- •American Society of Anesthesiology I or II (I = nor- mal healthy patient; II = patient with mild systemic disease);
- •Adequate dento-oral health (i.e., the absence of periodontal diseases, periapical infection, or untreated caries).
排除标准
- •controlled periodontitis with a loss of alveolar support >10%
- •gingival recession >2 mm
- •altered bone metabolism (e.g., due to antiresorptive drug, steroid, or immunosuppressant use)
- •mental or motor disabilities; and 6) pregnancy.
研究组 & 干预措施
Insignia orthodontic treatment
干预措施: Orthodontic Procedure (Procedure)
Piezocision-assisted Insignia orthodontic treatment
干预措施: Orthodontic Procedure (Procedure)
Piezocision-assisted Insignia orthodontic treatment
干预措施: Piezocision surgery (Procedure)
结局指标
主要结局
Overall treatment time measurement (in days)
时间窗: 1 year
The cumulative times from bracket placement to each archwire change and to orthodontic appliance removal will be recorded in days.
次要结局
- Comparison of periodontal parameters between the test group and the control group before (at baseline) and after orthodontic treatment.(baseline, 1 year)
- Alveolar crest parameters measurements (CBCT in millimeters)(baseline, 1 year)
- Comparison of radiographic parameters between the test group and the control group before (at baseline) and after orthodontic treatment (CBCT)(baseline, 1 year)
- Comparison of Patient-centered outcomes (VAS questionnaire) between the test group and the control group before (at baseline) and after orthodontic treatment(baseline, 1 year)
研究者
Dr. France LAMBERT
Prof. France Lambert
University of Liege