Manus AI-Assisted Orthodontic Education and Oral Health-Related Quality of Life
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Malaya
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Conventional Orthodontic Education
BehavioralParticipants 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.
Manus AI-Assisted Orthodontic Education
BehavioralParticipants 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.
Treatment groups
230 Participants
are divided into 2 treatment groupsGroup A: Conventional EducationActive comparator 1 intervention
Group B: Manus AI-Assisted EducationExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
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 months2
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 monthsSecondary outcomes
1
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 months2
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 months3
Relationship 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 monthsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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