COMPARISON OF THE PERCEPTION OF PAIN BETWEEN ORTHODONTIC TREATMENT WITH Invisalign ® AND TREATMENT WITH BRACKETS
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- PAIN DURING INVISALIGN TREATMENT
研究概览
简要总结
This study aims to compare the pain experienced by patients undergoing orthodontic treatment with Invisalign ® corrective aligners with that of patients undergoing orthodontic treatment with conventional braces. Because the aligners are removable, nearly invisible and don't involve metal that can irritate teeth and gums, we are expecting less pain in the Invisalign Treatment and less affectation of the quality of life.
详细描述
The aims of the study are to determine:
the presence of pain, the magnitude of pain, the duration of pain, and the location of pain.
The hypotheses of this study are:
- Treatment with Invisalign ® aligners result in less pain than the braces
- Treatment with Invisalign ® aligners result in less irritation to the soft tissues with braces
- Pain should increase each time the aligners are put in the mouse and decrease until disappearing on the third day.
- The quality of life will be most affected by treatment with braces than with Invisalign ®.
- Null Hypothesis: There is no difference at all points between the two treatments.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •In permanent dentition;
- •Age less than 30 years;
- •No medical contraindications or presence of systemic diseases (including nervous system disorders);
- •No missing teeth except the third molars;
- •Orthodontic treatment without extraction.
- •Relationship skeletal cl. I (or slightly cl. II or cl. III)
- •Speak and understand French without help.
排除标准
- •lack of compliance with appointments.
结局指标
主要结局
PAIN DURING INVISALIGN TREATMENT
时间窗: 6 MONTHS
A questionnaire will be completed by the patient at different time points during treatment. This questionnaire includes questions on descriptive pain: location, duration, alteration in quality of life and a visual analog scale (VAS).
次要结局
未报告次要终点
研究者
Hicham El-Khatib
Associate professor, Doctor of Dental Medecine
Université de Montréal