Clinical trial NCT06980701: Improving Oral and Systemic Health in Individuals With Prediabetes Through Personalized Oral Hygiene Advice Provided by Dentists or by AI
Official title: Improving Oral and Systemic Health in Individuals With Prediabetes Through Personalized Oral Hygiene Advice Provided by Dentists or by Artificial Intelligence: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gum Disease
Prediabetes
Keywords: gum disease
prediabetes
oral health
oral hygiene
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2025-05-20
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Prediabetes is an intermediate stage before the development of diabetes, characterized by elevated blood glucose levels but lower than the diagnostic criteria of diabetes and is associated with multiple long-term complications. This systemic disease is mutually linked to inflammatory gum diseases through circulating inflammatory mediators. Controlling inflammatory gum diseases improves blood glucose levels and reduces long-term complications. While maintaining good oral hygiene through home care is essential for managing inflammatory gum diseases, close supervision of patients' home care is labor-intensive and expensive. Artificial Intelligence (AI) has been used to provide personalized advice on the adequacy of patients' home care (oral hygiene). The investigators hypothesize that the use of AI can improve home care, thereby enhancing both gum health and systemic health, similar to human dental professionals.

Detailed description: Prediabetes is an intermediate stage before the development of diabetes, characterized by elevated blood glucose levels but lower than the diagnostic criteria of diabetes and is associated with multiple long-term complications. This systemic disease is mutually linked to inflammatory gum diseases through circulating inflammatory mediators. The relation between oral health and prediabetes management has long been under-appreciated. People with prediabetes have a 2-3-fold greater risk for periodontitis compared to people without prediabetes. The progression and severity of periodontitis are also greater in prediabetic patients. According to the National Health and Nutrition Examination Survey, the severity of periodontitis is positively associated with the risk as well as the prevalence of prediabetes. A growing body of data indicates that oral inflammation has an impact on general diseases. Controlling inflammatory gum diseases improves blood glucose levels and reduces long-term complications. While maintaining good oral hygiene through home care is essential for managing inflammatory gum diseases, close supervision of patients' home care is labor-intensive and expensive.

Nowadays, artificial intelligence (AI) can readily assist in the self-detection of diseases, including gum disease, allowing older adults to identify diseases early and prevent further complications. The use of AI-based mHealth has become increasingly effective in promoting periodontal health by adopting simple, AI-driven self-tests using smartphones. Another systematic review done by investigators' team found that AI-based mHealth for oral hygiene and gum disease monitoring showed clinical effectiveness across different clinical scenarios. The investigators' team has already launched an AI system for the detection of gum disease using smartphone intraoral photography, in which the system can detect colour changes of gum inflammation in specific sites in intraoral photography and diagnose as three simple situations (severe, mild and no inflammation). The AI system have high sensitivity 92% to identify disease from sites that have gingivitis, and high specificity 94% to identify healthy tissue from sites that have no gingivitis using professional intraoral photography. Moreover, the investigators have tested that the accuracy of colour captured by a smartphone is comparable to that captured by a professional single-lens reflective camera. The investigators' team already have applied the AI-powered smartphone photography among 38 older adults in 5 day-care centres of Hong Kong to test participants' gum health. The result is promising with accuracy of 96% sensitivity and 82% specificity. The present study will apply AI technology on disease detection and giving personalized oral health instruction (OHI) closely to the patients to maintain periodontal health and consequently prediabetic control.

In this study, the hypothesis is that the use of AI can improve home care, thereby enhancing both gum health and systemic health, similar to human dental professionals.

Eligibility criteria: Inclusion Criteria:

* - Subjects who are \>18 years of age and able to give informed consent.
* - Subjects who are mentally and cognitively healthy.
* - Subjects who have at least 6 anterior maxillary or mandibular natural teeth including incisors and canine.
* - Subjects who are with prediabetic state with impaired HbA1c 5.7% to 6.4%, impaired fasting plasma glucose level 5.6mmol/L to 6.9 mmol/L and/or impaired plasma glucose level after 2h OGTT 7.8 mmol/L to 11.0 mmol/L.
* - Subjects who can speak, read, or understand Cantonese to 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 6 anterior maxillary or mandibular natural teeth with or without dental prostheses in those area.
* - Subjects who are with a current diagnosis or clinical history of T2DM.
* - 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.

Primary outcomes:
measure: Gum inflammation at baseline
timeFrame: baseline
measure: Gingival health at baseline
timeFrame: baseline
measure: Oral hygiene status at baseline
timeFrame: baseline
measure: HbA1c level at baseline
timeFrame: baseline
measure: FPG level at baseline
timeFrame: baseline
measure: 2-h PG during 75-g OGTT level at baseline
timeFrame: baseline
measure: Gum inflammation at 3-month
timeFrame: 3-month
measure: Gingival health at 3-month
timeFrame: 3-month
measure: Oral hygiene status at 3-month
timeFrame: 3-month
measure: HbA1c level at 3-month
timeFrame: 3-month
measure: FPG level at 3-month
timeFrame: 3-month
measure: 2-h PG during 75-g OGTT level at 3-month
timeFrame: 3-month
Secondary outcomes:
measure: C-reactive protein level at baseline and 3 months
timeFrame: at baseline and 3 month
measure: IL6 level at baseline and 3 months
timeFrame: at baseline and 3 month
measure: IL8 level at baseline and 3 months
timeFrame: at baseline and 3 month
measure: Body weight at baseline and 3 month
timeFrame: at baseline and 3 month
measure: Percentage body fat at baseline and 3 month
timeFrame: at baseline and 3 month
measure: Shannon diversity index of oral and gut microbiota at baseline and 3 months
timeFrame: at baseline and 3 months
measure: Concentration of short chain fatty acid in stool samples at baseline and 3 months
timeFrame: at baseline and 3 months
measure: 3-day food record at baseline and 3 months
timeFrame: at baseline and 3 months
measure: Chinese version of Chrono-nutrition Profile Questionnaire at baseline and 3 months
timeFrame: at baseline and 3 months
measure: Chinese version of Munich Chronotype Questionnaire at baseline and 3 months
timeFrame: at baseline and 3 months
measure: Chinese version of international physical activity questionnaire short form at baseline and 3 months
timeFrame: at baseline and 3 months
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Prince Philip Dental Hospital
state: Sai Ying Pun
Study officials:
affiliation: The University of Hong Kong
name: Walter Y.H. Lam, Prof.
role: PRINCIPAL_INVESTIGATOR
References: