Oral Health-Related Quality of LifeNCT07832604
Manus AI-Assisted Orthodontic Education and Oral Health-Related Quality of Life
A study testing Conventional Orthodontic Education and Manus AI-Assisted Orthodontic Education in people with Oral Health-Related Quality of Life, run by University of Malaya.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Health-Related Quality of Life
- What is being tested?
- Conventional Orthodontic Education and Manus AI-Assisted Orthodontic Education
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- No sites listed yet
- Study dates
- 15 Nov 2026to 15 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years and above.
- Patients scheduled to commence fixed orthodontic appliance treatment
- Able to read and understand English or Malay.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
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.
Read the detailed description
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.
- Conditions
- Oral Health-Related Quality of Life
- Being tested
- Conventional Orthodontic Education, Manus AI-Assisted Orthodontic Education
- Keywords
- Orthodontics, Artificial Intelligence, Patient Education, Oral Health-Related Quality of Life, Fixed Orthodontic Appliances, OIDP, PIDAQ
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Orthodontic EducationBehavioural
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.
Manus AI-Assisted Orthodontic EducationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Conventional Orthodontic Education; Behavioral: Manus AI-Assisted Orthodontic Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, 3 months, and 6 months
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study start15 Nov 2026 (estimated)
- Primary completion15 Jul 2027 (estimated)
- Study completion15 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Health-Related Quality of LifeStudies of the same condition, open and under way.
- More trials run by University of MalayaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07832604
- Sponsor's protocol ID
- UMG022E-2026
- Status last verified
- Sep 2026
- First submitted
- 16 Sep 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with other researchers in order to protect participant confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07832604
- Acronym / sponsor ID
- UMG022E-2026
- Conditions
- Oral Health-Related Quality of Life
- Keywords
- Orthodontics, Artificial Intelligence, Patient Education, Oral Health-Related Quality of Life, Fixed Orthodontic Appliances, OIDP, PIDAQ
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- 15 Nov 2026 (estimated)
- Primary completion
- 15 Jul 2027 (estimated)
- Study completion
- 15 Jul 2027 (estimated)
- First posted
- 22 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Conventional Education | Active comparator | Behavioral: Conventional Orthodontic EducationParticipants 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. |
| Manus AI-Assisted Education | Experimental | Behavioral: Conventional Orthodontic Education, Behavioral: Manus AI-Assisted Orthodontic EducationParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults aged 18 years and above.
- Patients scheduled to commence fixed orthodontic appliance treatment
- Able to read and understand English or Malay.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional Orthodontic EducationParticipants 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. | Behavioural | Conventional Education, Manus AI-Assisted Education |
| Manus AI-Assisted Orthodontic EducationParticipants 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. | Behavioural | Manus AI-Assisted Education |
Primary outcome
Change in Psychosocial Impact of Dental Aesthetics Questionnaire (PIDAQ) Total Score
Time frame: 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
Time frame: 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.
3 secondary outcomes
Change in OIDP Domain Scores
Time frame: Baseline, 3 months, and 6 months
Change in PIDAQ Subscale Scores
Time frame: Baseline, 3 months, and 6 months
Correlation Between Changes in OIDP and PIDAQ Total Scores
Time frame: Baseline to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with other researchers in order to protect participant confidentiality.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Orthodontic Education and Manus AI-Assisted Orthodontic Education in people with Oral Health-Related Quality of Life, run by University of Malaya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chenxu su, Bachelor of Medicine in Stomat (60 173242016, suchenxu47@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Psychosocial Impact of Dental Aesthetics Questionnaire (PIDAQ) Total Score (time frame: Baseline, 3 months, and 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.