Manus AI-Assisted Orthodontic Education and Oral Health-Related Quality of Life

NCT07832604 | Not Yet Recruiting DMC

• 1 other identifier: UMG022E-2026
• Study Type: interventional
• Target: 230
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Oral Health-Related Quality of Life During Orthodontic Treatment

Keywords

Orthodontics; Artificial Intelligence; Patient Education; Oral Health-Related Quality of Life; Fixed Orthodontic Appliances; OIDP; PIDAQ

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline, 3 months, and 6 months

Secondary Outcomes (3)

• 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

Study Arms (2)

Conventional Education

ACTIVE COMPARATOR

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

Manus AI-Assisted Education

EXPERIMENTAL

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

Interventions

Conventional Orthodontic Education BEHAVIORAL

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.

Conventional Education; Manus AI-Assisted Education

Manus AI-Assisted Orthodontic Education BEHAVIORAL

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.

Manus AI-Assisted Education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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. -

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Malaya: lead

Central Study Contacts

Chenxu su, Bachelor of Medicine in Stomat

CONTACT

60 173242016; suchenxu47@gmail.com

Wan Nurazreena Wan Hassan, MScD

CONTACT

+60379674802; wannurazreena@um.edu.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned in a 1:1 ratio to one of two parallel groups: conventional orthodontic education or conventional orthodontic education plus Manus AI-assisted education. Both groups will be followed for 6 months.

Study Record Dates

• First Submitted: September 16, 2026
• First Posted: September 22, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): July 15, 2027
• Study Completion (Estimated): July 15, 2027
• Last Updated: September 22, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share