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Gum InflammationNCT07187453

Improving Gum Health Among Older Adults Using AI Based mHealth for Personalized OHI

A study testing Personalized Oral Hygiene Advice using AI assisted mHealth Tool by Non-Dental Personnel in people with Gum Inflammation and Periodontal Diseases, run by The University of Hong Kong at 1 site in Hong Kong.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Background: Many older adults in Hong Kong lack thorough tooth cleaning and regular dental check-ups, which can lead to plaque-induced gum diseases and systemic health issues. A self-developed Mobile Health (mHealth) system, which utilizes smartphone photographs and artificial intelligence (AI), has been shown to… Read more about this study

Who is it for?
Ages 60 years and olderHealthy volunteers can take part
What is being tested?
Personalized Oral Hygiene Advice using AI assisted mHealth Tool by Non-Dental Personnel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
88 participants
Where
1 siteHong Kong
Study dates
10 Sep 2025to 10 Jul 2026
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 60 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Subjects aged ≥60 years and able to give informed consent:
  • Subjects who are mentally and cognitively healthy
  • Subjects who have at least 20 anterior maxillary or mandibular natural teeth including incisors and canine.
  • Subjects who can speak, read, or understand Cantonese for complete the satisfaction questionnaire.
  • Subjects who can practice oral hygiene procedure (regular tooth brushing and interdental cleansing/flossing/brushing) daily on their own independently.

Who cannot join

  • Subjects who have less than 20 anterior maxillary or mandibular natural teeth with or without dental prostheses in those area.
  • Subjects who have mental illness, or similar problems that unable to complete the satisfaction questionnaire.
  • Subjects who cannot perform oral hygiene procedure (regular tooth brushing and interdental cleansing/flossing/brushing) by any condition of oral cavity such as tumor or maxillomandibular fixation.
  • Subjects who cannot attend weekly oral hygiene instruction at centers.

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site
  • Prince Philip Dental Hospital

    Hong Kong, Central and Western, 999077

Other trials in Hong Kong

About this study

Official title: Improving Gum Health Among Older Adults in Hong Kong Through Artificial Intelligence-Based Mobile Health for Personalized Oral Hygiene Instruction

Background: Many older adults in Hong Kong lack thorough tooth cleaning and regular dental check-ups, which can lead to plaque-induced gum diseases and systemic health issues. A self-developed Mobile Health (mHealth) system, which utilizes smartphone photographs and artificial intelligence (AI), has been shown to accurately detect gum health. Personalized oral hygiene instruction (POHI) can then be provided based on the detected results.

Objectives:

Read more
  1. To improve gum health among non-institutionalized older adults using mHealth and POHI.
  2. To evaluate the clinical effectiveness of mHealth and POHI in improving gum health.

Hypothesis: The personalized oral hygiene instruction (OHI) in addition to AI based mHealth provided by volunteer social workers can improve clinical effectiveness and oral health related quality of life (OHRQoL).

Design and subjects: 88 older adults will be recruited from daycare centers, who will receive bi-weekly POHI based on their gum condition, detected by mHealth which is provided by trained volunteers.

Two calibrated assessors will assess the participants' gum health, oral hygiene, caries, dental plaque, and structured questionnaire at baseline, after 3 months, 6 months, 9 months and 1 year Study Instruments: Gingival Index, Plaque Index, International Caries Detection and Assessment System (ICDAS) code, dental plaque microbiology, and Geriatric Oral Health Assessment Index (GOHAI) + Structured Questionnaire.

Interventions: Personalized oral hygiene instruction using AI-powered mHealth provided by trained volunteers bi-weekly Main Outcomes: Gingival condition, Oral hygiene status, Dental plaque microbiology, and oral health-related quality of life.

Data analysis: t-tests and Wilcoxon rank-sum test will compare pre- and post-intervention data.

Expected Result: The use of mHealth and POHI provided by trained volunteers bi-weekly can lead to improved gum health among older adults.

Read the detailed description

The project will be conducted in prospective design (pre- and post-) comparing before and after the intervention without sub-group. Eligible elderly will receive bi-weekly AI-based mHealth and personalized OHI provided by (non-dental) trained volunteers. The recruitment of participants among Hong Kong elderly would be according to the following pre-set criteria. The clinical effectiveness of bi-weekly AI-based mHealth and personalized OHI provided by volunteer (non dental professonial people) will be assessed by Gingival Index, Plaque Index, Dental plaque microbilology, the International Caries Detection and Assessment System (ICDAS), and Structured Questionnaire for Oral Health Related Quality of Life (OHRQoL). The time interval for intervention will be up to 1 year. The assessments will be performed at baseline and 3-month, 6-month, 9-month and 1-year intervals.

Approximately 50 volunteers will be recruited through the respective district council of the participating day care centers in Hong Kong. They will be provide a one-day training at Faculty of Dentistry, the University of Hong Kong, regarding how to operate the mHealth system, provide personalized feedback based on the AI outputs, basics of conducting the structured interviews, and communicate with the subjects.

Subjects: 88 eligible subjects will be recruited through three day-care centers in Hong Kong.

(Pre) Baseline: Written informed consent will be obtained on the day of the baseline examination. Sociodemographic information such as age, gender, education, occupation, and medical conditions will be collected. The intraoral photo of participants will be taken for reference status of baseline. Two independent assessors will assess participants' gingival health status using gingival index, oral hygiene status using plaque index and participants' caries status using ICDAS criteria. Dental plaque on surface layer of root will be carefully collected without causing pain using sterilized excavators from two sites of each participant with root caries i.e. dental plaque from the sound root surface and root caries. Each Sample will be immediately suspended in 300 μl ethanol and frozen at -80°C later until further analysis of microbiome composition. Additionally, patient's demographics and OHRQoL using structured questionnaires and Geriatric Oral Health Assessment Index (GOHAI) will be assessed.

Intervention: Participants will need to join for 3 months to 1 year. The participants will receive baseline and bi-weekly mHealth intervention to test the gum condition and receive personalized OHI to specific areas based on the result tested. Trained volunteers will take the anterior teeth and gum photo of participants with a smartphone camera at their homes or elderly centers without using any additional device such as retractors. Participants may need to pull the lips and cheek by their hands for photo taking. The photo will be uploaded into AI powered gum disease detection mobile application (GumAI app) by volunteers. The mHealth system will screen the intraoral photograph of anterior teeth, analyse the photograph, and label the gum condition as Healthy (green)/questionable (yellow)/diseased (red) within 2 minutes. According to the results tested by GumAI app, the volunteers will give personalized site specific OHI such as tooth brushing and interdental cleaning to elderly participants. This instruction includes brushing and interdental cleaning. If they have any personal concern or unclear points regarding oral hygiene practice, they can ask.

(Post) Assessment: The same assessment as in baseline at 3- months, 6 months, 9 months and 1 year will be examined by 2 calibrated dentists.

Being tested
Personalized Oral Hygiene Advice using AI assisted mHealth Tool by Non-Dental Personnel
Keywords
Gum Health, Oral Hygiene, Oral Health, Mobile Health, Artificial Intelligence, Elderly, Personalized Oral Hygiene Instruction
Medical subject headings
Gingivitis, Periodontal Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Personalized Oral Hygiene Advice using AI assisted mHealth Tool by Non-Dental PersonnelBehavioural

    The intervention involve the delivering personalized oral hygiene advice using AI assisted gum disease screening tool by non-dental personnel social workers. Our proposed intervention involve AI to assist in the self-detection of gum disease, and emphasizes the use of mHealth for disease prevention and monitoring. Moreover, the proposed project focuses on providing personalized oral hygiene instruction, which can be utilized or provided by non-dental personnel volunteers. This combination of AI, mHealth, and personalized instruction in addition with regular service of non-dental personnel volunteers is a novel approach in managing periodontal health among older adults.

Study groups in NCT07187453
Study groupRoleWhat they receive
Test Group (only)ExperimentalThis study is single test group (no control) study with pre vs post design. The (only) single test group will receive an intervention which involve the delivering personalized oral hygiene advice using AI assisted gum disease screening tool by non-dental personnel social workers.
Receives: Behavioral: Personalized Oral Hygiene Advice using AI assisted mHealth Tool by Non-Dental Personnel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Plaque Index

    Oral Hygiene status assessment using plaque index ((Silness and Loe, 1965), with a scale from 0 to 3 (higher scores mean worse outcome) on index teeth only as follow.

    0 = No plaque in the gingival area.

    1. = A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may only be recognized by running a probe across the tooth surface.
    2. = Moderate accumulation of soft deposits within the gingival pocket, on the gingival margin and/or adjacent tooth sur- face, which can be seen by the naked eye.
    3. = Abundance of soft matter within the gingival pocket and/or on the gingival margin and adjacent tooth surface.

    Measured: From enrollment (Baseline) Vs 3 months Vs 6 months Vs 9 months Vs 1 year

  2. Gingival Index

    Gingival health status assessment using gingival index. Dentist will perform clinical examination of anterior teeth using mouth mirror and periodontal probe to grade gingival index (gingival index (Löe H 1967), with a scale from 0 to 3, (higher scores mean worse outcome)) on index teeth.

    0 = normal gingiva;

    1. = mild inflammation: a slight change in colour, slight oedema, no bleeding on probing;
    2. = moderate inflammation: redness, oedema, glazing, or bleeding on probing;
    3. = severe inflammation: marked redness and oedema, a tendency toward spontaneous bleeding, and ulceration.

    Measured: From enrollment (Baseline) Vs 3months Vs 6 months Vs 9 months Vs 1 year

Secondary outcomes (3)
  1. Dental plaque microbiology

    The contents of microbiome in dental plaques from root caries will be investigated. From collected and stored plaque samples, total DNA will be extracted from pellets centrifuged using QIAamp DNA Mini Kit (Qiagen, USA). An aliquot of DNA will be used to screen the bacterial microbiome community using 16S rRNA gene V3-V4 region (~450 bp) amplicon sequencing.

    Measured: At baseline only (cross sectional data)

  2. International Caries Detection and Assessment System (ICDAS) for dental caries status

    (Code 0,A,B,C,E, higher scores, worse outcome) Code 0/Sound: Root surface does not exhibit any unusual discoloration that distinguishes it from the surrounding or adjacent root areas nor does it exhibit a surface defect either at the cement-enamel junction or wholly on root surface.

    Code A/Initial lesion: clearly demarcated area on the root surface or at the cement-enamel junction (CEJ) that is discolored (light/dark brown, black) but no cavitation present (loss of anatomical contour < 0.5 mm).

    Code B/Moderate lesion: clearly demarcated area on the root surface or at the CEJ that is discolored (light/dark brown, black) and cavitation (loss of anatomical contour ≥ 0.5 mm ≤ -2 mm) present.

    Code C/Extensive lesion: clearly demarcated area on the root surface or at the CEJ that is discolored (light/dark brown, black) and cavitation (loss of anatomical contour > 2mm) present.

    Code E: If for any reason a root surface cannot be visualized directly

    Measured: From enrollment (Baseline) Vs 3 months Vs 6 months Vs 9 months Vs 1 year

  3. The Geriatric Oral Health Assessment Index (GOHAI)

    A structured interview tool to evaluate participants' oral health-related quality of life. Geriatric Oral Health Assessment Index (GOHAI - Chinese Version) will be used as a structured interview tool to evaluate participants' oral health-related quality of life. 12 questionnaires focusing on patients' perspective, self-reported outcomes on behavioral, knowledge and awareness would be asked to all participants at baseline and 3- month ( using all in Chinese Version) format. The score ranges 12-60 for a 5-level scale, in which higher scores mean better outcome.

    Measured: From enrollment (Baseline) Vs 3 months Vs 6 months Vs 9 months Vs 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Sep 2025
  2. Study start10 Sep 2025
  3. Primary completion31 Dec 2025
  4. Study completion10 Jul 2026 (estimated)

Resources

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
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
88 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07187453
Sponsor's protocol ID
UW 25-043
Status last verified
Apr 2026
First submitted
18 Sep 2025
Last updated
30 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Chau RCW, Cheng ACC, Mao K, Thu KM, Ling Z, Tew IM, Chang TH, Tan HJ, McGrath C, Lo WL, Hsung RT, Lam WYH. External Validation of an AI mHealth Tool for Gingivitis Detection among Older Adults at Daycare Centers: A Pilot Study. Int Dent J. 2025 Jun;75(3):1970-1978. doi: 10.1016/j.identj.2025.01.008. Epub 2025 Jan 26.

    PubMed 39864975
  • Chau RCW, Li GH, Tew IM, Thu KM, McGrath C, Lo WL, Ling WK, Hsung RT, Lam WYH. Accuracy of Artificial Intelligence-Based Photographic Detection of Gingivitis. Int Dent J. 2023 Oct;73(5):724-730. doi: 10.1016/j.identj.2023.03.007. Epub 2023 Apr 26.

    PubMed 37117096
  • Chau RCW, Thu KM, Chaurasia A, Hsung RTC, Lam WY. A Systematic Review of the Use of mHealth in Oral Health Education among Older Adults. Dent J (Basel). 2023 Aug 8;11(8):189. doi: 10.3390/dj11080189.

    PubMed 37623285
  • Chau RC, Thu KM, Hsung RT, McGrath C, Lam WY. Self-monitoring of Oral Health Using Smartphone Selfie Powered by Artificial Intelligence: Implications for Preventive Dentistry. Oral Health Prev Dent. 2024 Sep 23;22:327-340. doi: 10.3290/j.ohpd.b5758200.

    PubMed 39308412

Questions about this trial

What is this clinical trial studying?

A study testing Personalized Oral Hygiene Advice using AI assisted mHealth Tool by Non-Dental Personnel in people with Gum Inflammation and Periodontal Diseases, run by The University of Hong Kong at 1 site in Hong Kong.

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 5 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: under way, not looking for participants, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Plaque Index (time frame: From enrollment (Baseline) Vs 3 months Vs 6 months Vs 9 months Vs 1 year). 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?

On the ClinicalTrials.gov record for NCT07187453, which also lists 4 linked publications.

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 30 Apr 2026.

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