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临床试验/NCT07187453
NCT07187453进行中(未招募)不适用

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

The University of Hong Kong1 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2025年9月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
88
试验地点
1
主要终点
Plaque Index

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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.

排除标准

  • •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.

研究组 & 干预措施

Test Group (only)

Experimental

This 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.

干预措施: Personalized Oral Hygiene Advice using AI assisted mHealth Tool by Non-Dental Personnel (Behavioral)

结局指标

主要结局

Plaque Index

时间窗: 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. 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.

Gingival Index

时间窗: 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; 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.

Plaque Index

时间窗: 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. 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.

Gingival Index

时间窗: 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; 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.

次要结局

  • International Caries Detection and Assessment System (ICDAS) for dental caries status(From enrollment (Baseline) Vs 3 months Vs 6 months Vs 9 months Vs 1 year)
  • The Geriatric Oral Health Assessment Index (GOHAI)(From enrollment (Baseline) Vs 3 months Vs 6 months Vs 9 months Vs 1 year)
  • Dental plaque microbiology(At baseline only (cross sectional data))
  • International Caries Detection and Assessment System (ICDAS) for dental caries status(From enrollment (Baseline) Vs 3 months Vs 6 months Vs 9 months Vs 1 year)
  • The Geriatric Oral Health Assessment Index (GOHAI)(From enrollment (Baseline) Vs 3 months Vs 6 months Vs 9 months Vs 1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Walter Y.H. Lam

Clinical Associate Professor

The University of Hong Kong

研究点 (1)

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