An interventional study of Conventional Orthodontic Education and Manus AI-Assisted Orthodontic Education in Oral Health-Related Quality of Life, sponsored by University of Malaya. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by University of Malaya · Not applicable, Interventional, and Supportive care
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.
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.
University of Malaya is the lead sponsor of 284 studies on the registry; 58 are open to participants now.
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The criteria were revised on the registry on Oct 27, 2026. See what changed
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Exclusion Criteria:
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.
Behavioral: Conventional Orthodontic 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.
Behavioral: Conventional Orthodontic Education · Behavioral: Manus AI-Assisted Orthodontic Education
Participants will receive a standardized conventional orthodontic education package covering oral hygiene, brushing and interdental cleaning, care of fixed orthodontic appliances, dietary advice, management of common orthodontic discomfort, and appointment-related guidance.
Participants in the AI-assisted education group will receive access to a Manus-based orthodontic education chatbot for 6 months in addition to conventional orthodontic education. The chatbot provides educational support for routine orthodontic questions, including oral hygiene, appliance care, dietary advice, and common treatment-related discomfort. It does not provide diagnosis, treatment planning, or clinical decision-making.
Change in Psychosocial Impact of Dental Aesthetics Questionnaire (PIDAQ) Total Score
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.
Time frame: Baseline, 3 months, and 6 months
Change in Oral Impacts on Daily Performances (OIDP) Total Score
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.
Time frame: Baseline, 3 months, and 6 months
Change in OIDP Domain Scores
Changes in the eight individual OIDP domain scores will be assessed to examine specific effects on 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, with higher scores indicating a greater negative impact on that daily activity.
Time frame: Baseline, 3 months, and 6 months
Change in PIDAQ Subscale Scores
Changes in the four PIDAQ subscale scores will be assessed: Dental Confidence, Social Impact, Psychological Impact, and Aesthetic Concern. The theoretical score ranges are 0 to 24 for Dental Confidence, 0 to 32 for Social Impact, 0 to 24 for Psychological Impact, and 0 to 8 for Aesthetic Concern.
Time frame: Baseline, 3 months, and 6 months
Correlation Between Changes in OIDP and PIDAQ Total Scores
Changes in OIDP and PIDAQ total scores from baseline to 6 months will be calculated for each participant. The study will examine whether changes in daily functioning measured by OIDP are associated with changes in the psychosocial impact of dental appearance measured by PIDAQ.
Time frame: Baseline to 6 months
No study locations are listed for this record.
Plan to share: No — Individual participant data will not be shared with other researchers in order to protect participant confidentiality.
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Jul 2027, 8 months later.
Start moved once since we started tracking on Sep 25, 2026: Oct 2026 → Nov 2026, on Nov 4, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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