The Impact of A Modified Aligner Appliance With NiTi Springs and Conventional Fixed Appliances on Oral Health-related Quality of Life in Patients With Mild Crowding
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Changes in oral health related quality of life
研究概览
简要总结
Patients who have mild crowding from the Orthodontic Department at University of Damascus Dental School will be treated in this trial. The effects of modified aligner appliance with NiTi springs on oral health-related quality of life (OHRQoL) compared with conventional fixed appliances using the OHIP-14 questionnaire during orthodontic treatment. So, this study aims to compare the changes in OHRQoL between patients receiving modified aligner appliances or conventional fixed appliances during orthodontic treatment.
There are two groups:
- Experimental group: the patients in this group will be treated using a modified aligner appliance.
- Control group: the patients in this group will be treated using conventional fixed appliances
详细描述
Most adult patients do not choose traditional fixed appliances due to concerns about appearance, lengthy treatment time, and challenges with oral hygiene. This study aimed to assess the impact on psychological well-being, aesthetics, and functionality of a novel single aligner appliance.
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 25 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged between (18 - 25) years.
- •Mild crowding < 4 mm in the lower dental arch with class I malocclusion
- •No congenitally missing or extracted teeth (except for third molars)
- •Patients with good oral hygiene.
排除标准
- •Bimaxillary dentoalveolar protrusion.
- •Previous orthodontic treatment.
- •Severe skeletal discrepancy.
结局指标
主要结局
Changes in oral health related quality of life
时间窗: T0: immediately before the start of orthodontic treatment; T1: after two weeks; T2: after one months; T3: after two months; T4: post-treatment
Patients in both groups will receive a survey called the Oral-Health-Impact-Profile with 14 items (OHIP-14) to complete at every adjustment visit. The OHIP-14 questionnaire assesses various aspects of the individual's oral health, functional well-being, emotional well-being, expectations, and satisfaction with care, and sense of self through subjective evaluation. The total score can range from 0 to 56, with higher scores indicating poorer OHRQoL. Each domain within the OHIP-14 score is also rated on a scale of 0 to 8, with individual items contributing a score of 0 to 4.
次要结局
- Patient satisfaction with the progress of the treatment(At the end of treatment which is expected to occur within 4 to 6 months)
- Patient satisfaction with the appearance of the orthodontic appliance(At the end of treatment which is expected to occur within 4 to 6 months)
- Patient satisfaction with the results of the treatment(At the end of treatment which is expected to occur within 4 to 6 months)