Patient's Expectations, Preferences, Experiences Before, During and After the Treatment With Invisalign® Aligners
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Patient expection on aligner therapy
研究概览
简要总结
Orthodontic treatment extends over a longer period of time. lt takes months or rather years and it is no short-term treatment. The current literature does not answer the question of patients' expectations on aligner treatment and patients' experiences during aligner therapy sufficiently. Therefore, it is clinically and ethically highly relevant to know answers to these questions. This knowledge can highly improve the orthodontic consultation and therapy as well as the patients' comfort and wellbeing during the therapy. The proposed questionnaire-based interview survey is anticipated as a two-vear study.
In the first year study patients' expectations and preferences before the aligner treatment with Invisalign® aligners will be evaluated as well as preliminary changes in quality of life during the first stages of the Invisalign® aligner treatment. In the second year study it is planned to continue with the time equivalent questionnaires of the first year study and to investigate the patients' expectations, patients' experiences and levels of quality of life during and after aligner treatment. Therefore, it is planned to enroll 55 patients in this multicentre questionnaire-based interview survey. Two different questionnaires will be handed out to the patients. The first questionnaire, the aligner questionnaire, collects information from three different time points regarding the patients' expectations, preferences, experiences and views on second opinion concerning the aligner treatment. The results of those three time points, i.e. first (Ta0 before treatment begin), second (Ta6Mo, after 6 months of treatment) and third (Ta final, after finishing the treatment) will be statistically described and compared over time.
We expect most questionnaires of the second (during aligner treatment) and third time points (after finishing of treatment) to be evaluated by the end of the second year (second-year study), as the average treatment duration is about two years. The aim of the second questionnaire (OHlP 14) is to find out the changes in quality of life and is scheduled be started already in the firsfyear study. This questionnaire will be handed out to the patients before the treatment begins (Tq0), at the first check-up after the beginning of the treatment (TqCo1) and semi-annually afterwards (Tq6Mo' Tq12Mo, Tq18Mo, Tq24Mo, Tq30Mo) and finally at the end of the treatment (Tq final).
详细描述
It is planned to enroll 55 patients in this study, which is designed as a longterm questionnaire-based multicenter survey. Patients have to give their written consent prior to the study. Patients of the Clinical Division of Orthodontics at the University Clinic of Dentistry in Vienna as well as of a private practice will be included in order to increase the results' significance. All patients will be examined beforehand in order to exclude other pre-orthodontical treatment. After a short briefing about the aligner procedure and the therapeutic alternatives, each patient is selected for the aligner treatment with lnvisalign®. At this stage the chosen patient will be informed about the survey. The patient will receive the written consent form and the patient information form to think about at home. Should the patient consider to take part in the study, the signed forms must be returned at the following appointment. The patient will now receive the details about the different questionnaires and the estimated time per questionnaire (approximately 10 mins).
Before the first treatment the patient is asked to fill out the first OHIP G 14 (Tq 0) and the first aligner-questionnaire (Ta 0). The participants will be categorized by gender' age and level of education (compulsory school degree, higher school certificate, apprenticeship, university degree). Patients who have already been treated with aligners will not be included in the study. The routine-made initial and final scans of the patients will be evaluated according to the criteria of the orthodontic PAR (peer assessment rating) index. lnclusion criteria:
- Invisalign® "full" aligner treatment
- Invisalign® "lite" aligner treatment
- Adult patients (18 years and older)
Exclusion criteria:
- Previous aligner treatment
- Combined orthodontic and orthognathic surgical treatment
- Combined bracket and aligner treatment
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Invisalign® "full" aligner treatment
- •Invisalign® "lite" aligner treatment
- •Adult patients (18 years and older)
排除标准
- •Previous aligner treatment
- •Combined orthodontic and orthognathic surgical treatment
- •Combined bracket and aligner treatment
结局指标
主要结局
Patient expection on aligner therapy
时间窗: up to 6 months
before treatment has started
次要结局
- Patient preferences and acceptences on aligner therapy(up to 12 months)
- Patient experiences on aligner therapy(up tp 24 months)
研究者
Michael Nemec
Dr. med. dent Dr. med. univ
Medical University of Vienna
