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

The University of Hong Kong148 enrolled

Overview

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.

Interventions

AI OHI groupBEHAVIORAL

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

Dental professionals OHI groupBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Gum inflammation at baseline

Gum inflammation will be evaluated using BPE score (from 0 to 4), which will be examined by a blinded assessor (a calibrated dentist who blinded to participants' group)

Time frame: baseline

Gingival health at baseline

Gingival health will be assessed by gingival index (Löe H 1967), with a scale from 0 to 3, which will be examined by a blinded assessor (a calibrated dentist who blinded to participants' group)

Time frame: baseline

Oral hygiene status at baseline

Oral hygiene status will be assessed by plaque index (Silness and Loe, 1965), with a scale from 0 to 3, which will be examined by a blinded assessor (a calibrated dentist who blinded to participants' group)

Time frame: baseline

HbA1c level at baseline

Glycaemic level at baseline is evaluated by HbA1c level (glycated haemoglobin that measures glycaemic control over the past 2-3 months). Prediabetes is defined as HbA1c of 5.7-6.4% (39-47 mmol/mol)

Time frame: baseline

FPG level at baseline

Glycaemic level at baseline is evaluated by FPG (fasting plasma glucose level that measures the blood sugar levels). Prediabetes is defined as 100-125 mg/dL (5.6-6.9 mmol/L)

Time frame: baseline

2-h PG during 75-g OGTT level at baseline

Glycaemic level at baseline is evaluated by 2-h PG during 75-g OGTT (plasma glucose level after 2-hour 75-g oral glucose tolerance test). Prediabetes is defined as 2-h PG during 75-g OGTT of 140-199 mg/dL (7.8-11.0 mmol/L)

Time frame: baseline

Gum inflammation at 3-month

Gum inflammation will be evaluated using BPE score (from 0 to 4), which will be examined by a blinded assessor (a calibrated dentist who blinded to participants' group) at 3-month follow up

Time frame: 3-month

Gingival health at 3-month

Gingival health will be assessed by gingival index (Löe H 1967), with a scale from 0 to 3, which will be examined by a blinded assessor (a calibrated dentist who blinded to participants' group) at 3-month follow-up

Time frame: 3-month

Oral hygiene status at 3-month

Time frame: 3-month

HbA1c level at 3-month

Glycaemic level at 3-month follow-up is evaluated by HbA1c level (glycated haemoglobin that measures glycaemic control over the past 2-3 months). Prediabetes is defined as HbA1c of 5.7-6.4% (39-47 mmol/mol)

Time frame: 3-month

FPG level at 3-month

Glycaemic level at 3-month follow-up is evaluated by FPG (fasting plasma glucose level that measures the blood sugar levels). Prediabetes is defined as 100-125 mg/dL (5.6-6.9 mmol/L)

Time frame: 3-month

2-h PG during 75-g OGTT level at 3-month

Glycaemic level at 3-month follow-up is evaluated by 2-h PG during 75-g OGTT (plasma glucose level after 2-hour 75-g oral glucose tolerance test). Prediabetes is defined as 2-h PG during 75-g OGTT of 140-199 mg/dL (7.8-11.0 mmol/L)

Time frame: 3-month

Gum inflammation at 9-month

Gum inflammation will be evaluated using BPE score (from 0 to 4), which will be examined by a blinded assessor (a calibrated dentist who blinded to participants' group) at 9-month follow up

Time frame: 9-month

Gingival health at 9-month

Time frame: 9-month

Oral hygiene status at 9-month

Time frame: 9-month

HbA1c level at 9-month

Glycaemic level at 9-month follow-up is evaluated by HbA1c level (glycated haemoglobin that measures glycaemic control over the past 2-3 months). Prediabetes is defined as HbA1c of 5.7-6.4% (39-47 mmol/mol)

Time frame: 9-month

FPG level at 9-month

Glycaemic level at 9-month follow-up is evaluated by FPG (fasting plasma glucose level that measures the blood sugar levels). Prediabetes is defined as 100-125 mg/dL (5.6-6.9 mmol/L)

Time frame: 9-month

2-h PG during 75-g OGTT level at 9-month

Glycaemic level at 9-month follow-up is evaluated by 2-h PG during 75-g OGTT (plasma glucose level after 2-hour 75-g oral glucose tolerance test). Prediabetes is defined as 2-h PG during 75-g OGTT of 140-199 mg/dL (7.8-11.0 mmol/L)

Time frame: 9-month

Secondary Outcomes

C-reactive protein level at baseline, 3-month and 9-month follow-ups

Inflammatory markers, i.e., C-reactive protein from serum, saliva and plaque samples (pg/mL) will be assessed at baseline, 3-month and 9-month follow-ups