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NCT Number: NCT07187453

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

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:

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.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Prince Philip Dental Hospital

Hong Kong, Central and Western, 999077

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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

Behavioral

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.

Primary outcomes

  1. Plaque Index

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

    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.

    • = 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.
    • = 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.
    • = Abundance of soft matter within the gingival pocket and/or on the gingival margin and adjacent tooth surface.
  2. Gingival Index

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

    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;

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

Secondary outcomes

  1. Dental plaque microbiology

    Time frame: At baseline only (cross sectional data)

    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.

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

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

    (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

  3. The Geriatric Oral Health Assessment Index (GOHAI)

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

    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.

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Sep 23, 2025
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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