A Randomised Clinical Trial to Assess the Use of a Manus-Assisted Artificial Intelligence-Based Education Model for Orthodontic Patients in Improving Their Oral Health-Related Quality of Life During Treatment Compared With Conventional Education Method
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 230
- 主要终点
- Change in Psychosocial Impact of Dental Aesthetics Questionnaire (PIDAQ) Total Score
研究概览
简要总结
The goal of this clinical trial is to learn whether adding artificial intelligence (AI)-assisted education to standard orthodontic education can improve quality of life in adults starting treatment with fixed braces. Specifically, the study aims to find out whether AI-assisted education can improve how oral health affects participants' daily activities and how participants feel about the appearance of their teeth and smile. To answer these questions, researchers will compare participants who receive standard orthodontic education with those who receive the same education plus access to a Manus-based AI chatbot for 6 months. All participants will receive standard education about caring for their teeth and braces during treatment and will complete questionnaires at the start of the study, after 3 months, and after 6 months. Participants will be randomly assigned to one of the two groups, and those in the AI-assisted education group will also use the chatbot during the 6-month study period. By comparing the two groups over time, the researchers will assess whether adding AI support provides extra benefits during orthodontic treatment.
详细描述
This study is a randomised clinical trial that will examine whether adding artificial intelligence (AI)-assisted education to standard orthodontic education can improve the treatment experience and oral health-related quality of life of adults starting treatment with fixed braces. Participants will receive the same standard orthodontic education about oral hygiene, caring for braces, diet, common discomfort, and routine treatment-related concerns. In addition, participants assigned to the AI-assisted education group will have access to a Manus-based orthodontic education chatbot for 6 months. The chatbot is designed to provide educational support for common questions that may arise during orthodontic treatment, such as how to clean around braces, manage minor discomfort, and follow dietary advice. It does not provide a diagnosis, treatment plan, or treatment decision, and participants will be advised to contact the clinic when professional assessment is needed. Researchers will assess participants at the start of the study, after 3 months, and after 6 months. The study will examine whether the added AI support changes how oral health affects daily activities and how participants feel about the appearance of their teeth and smile. These outcomes will be assessed using the Oral Impacts on Daily Performances (OIDP) and the Malaysian version of the Psychosocial Impact of Dental Aesthetics Questionnaire (PIDAQ). Researchers will compare changes over time between the two education groups and will also explore how changes in daily functioning are related to changes in the psychosocial effects of dental appearance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Adults aged 18 years and above. Patients scheduled to commence fixed orthodontic appliance treatment at the Postgraduate Orthodontic Clinic, Faculty of Dentistry, Universiti Malaya.
- •Able to read and understand English or Malay. Willing to provide written informed consent. -
排除标准
- •Cognitive impairment or learning difficulties that may interfere with understanding of the study or completion of questionnaires.
- •Use of medications that may affect cognitive ability. Dento-facial deformities or conditions requiring orthognathic treatment. Currently undergoing or previously having undergone removable orthodontic appliance therapy.
研究组 & 干预措施
Conventional Education
Participants will receive a standardized conventional orthodontic education package covering oral hygiene, care of fixed braces, dietary advice, management of common orthodontic discomfort, and appointment-related guidance.
干预措施: Conventional Orthodontic Education (Behavioral)
Manus AI-Assisted Education
Participants will receive a standardized conventional orthodontic education as the control group, together with access to a Manus-based AI orthodontic education chatbot for 6 months.
干预措施: Conventional Orthodontic Education (Behavioral)
Manus AI-Assisted Education
Participants will receive a standardized conventional orthodontic education as the control group, together with access to a Manus-based AI orthodontic education chatbot for 6 months.
干预措施: Manus AI-Assisted Orthodontic Education (Behavioral)
结局指标
主要结局
Change in Psychosocial Impact of Dental Aesthetics Questionnaire (PIDAQ) Total Score
时间窗: Baseline, 3 months, and 6 months
The psychosocial impact of dental appearance will be assessed using the Malaysian version of the Psychosocial Impact of Dental Aesthetics Questionnaire (PIDAQ). The questionnaire contains 22 items across four areas: Dental Confidence, Social Impact, Psychological Impact, and Aesthetic Concern. After reverse scoring the Dental Confidence items, the total PIDAQ score ranges from 0 to 88. Higher total scores indicate a greater negative psychosocial impact related to dental appearance.
Change in Oral Impacts on Daily Performances (OIDP) Total Score
时间窗: Baseline, 3 months, and 6 months
Oral health-related quality of life will be assessed using the Oral Impacts on Daily Performances (OIDP) instrument. The OIDP assesses eight areas of daily life, including eating, speaking, cleaning teeth, sleeping and relaxing, smiling, emotional well-being, major work or social activities, and social interaction. Each domain score ranges from 0 to 25, and the total raw score ranges from 0 to 200. The total score may be converted to a percentage ranging from 0 to 100. Higher scores indicate a greater negative impact of oral health problems on daily life and poorer oral health-related quality of life.
次要结局
- Change in OIDP Domain Scores(Baseline, 3 months, and 6 months)
- Change in PIDAQ Subscale Scores(Baseline, 3 months, and 6 months)
- Relationship Between Changes in OIDP and PIDAQ Total Scores(Baseline to 6 months)