NCT06980701

Improving Oral and Systemic Health in Individuals With Prediabetes Through Personalized Oral Hygiene Advice Provided by Dentists or by AI

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 148 (estimated)
• Sponsor: The University of Hong Kong · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gum Disease
• Prediabetes

Interventions

Type	Name	Description
BEHAVIORAL	AI OHI group	The participants will receive personalized OHI such as toothbrush and interdental cleaning to specific areas provided by AI. An mHealth system will be used to detect intraoral photograph of anterior teeth and analysis of the photograph and label the gum condition as Healthy (green)/questionable (yellow)/diseased (red) within 2 minutes by AI. Then specific OHI to each particular site would be provided by AI according to tested results on the photograph
BEHAVIORAL	Dental professionals OHI group	ll participants will receive personalized OHI by dental professionals. This instruction includes brushing and interdental cleaning in each particular dental site. If they have any personal concern or unclear points regarding oral hygiene practice, they can ask.

Timeline

• Start date: 2025-04-12
• Primary completion: 2026-04-18
• Completion: 2026-04-18
• First posted: 2025-05-20
• Last updated: 2025-12-03

Locations

1 site across 1 country: Hong Kong