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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 148
- 试验地点
- 1
- 主要终点
- Gum inflammation at baseline
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- 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.
排除标准
- •- 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.
研究组 & 干预措施
AI OHI group
Personalized oral hygiene instructions provided by AI on the adequacy of patients' home care.
干预措施: AI OHI group (Behavioral)
Dental professionals OHI group
Personalized oral hygiene instructions provided by a dental professional on the adequacy of patients' home care
干预措施: Dental professionals OHI group (Behavioral)
结局指标
主要结局
Gum inflammation at baseline
时间窗: 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)
Gingival health at baseline
时间窗: 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)
Oral hygiene status at baseline
时间窗: 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)
HbA1c level at baseline
时间窗: 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)
FPG level at baseline
时间窗: 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)
2-h PG during 75-g OGTT level at baseline
时间窗: 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)
Gum inflammation at 3-month
时间窗: 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
Gingival health at 3-month
时间窗: 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
Oral hygiene status at 3-month
时间窗: 3-month
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) at 3-month follow-up
HbA1c level at 3-month
时间窗: 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)
FPG level at 3-month
时间窗: 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)
2-h PG during 75-g OGTT level at 3-month
时间窗: 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)
Gum inflammation at baseline
时间窗: 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)
Gingival health at baseline
时间窗: 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)
Oral hygiene status at baseline
时间窗: 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)
HbA1c level at baseline
时间窗: 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)
FPG level at baseline
时间窗: 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)
2-h PG during 75-g OGTT level at baseline
时间窗: 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)
Gingival health at 3-month
时间窗: 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
Oral hygiene status at 9-month
时间窗: 9-month
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) at 9-month follow-up
Gum inflammation at 3-month
时间窗: 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
Gum inflammation at 9-month
时间窗: 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
Oral hygiene status at 3-month
时间窗: 3-month
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) at 3-month follow-up
HbA1c level at 3-month
时间窗: 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)
FPG level at 3-month
时间窗: 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)
2-h PG during 75-g OGTT level at 3-month
时间窗: 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)
Gingival health at 9-month
时间窗: 9-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 9-month follow-up
HbA1c level at 9-month
时间窗: 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)
2-h PG during 75-g OGTT level at 9-month
时间窗: 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)
FPG level at 9-month
时间窗: 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)
次要结局
- IL8 level at baseline, 3-month and 9-month follow-ups(at baseline, 3-month and 9-month follow-ups)
- Body weight at baseline, 3-month and 9-month follow-ups(at baseline, 3-month and 9-month follow-ups)
- Percentage body fat at baseline, 3-month and 9-month follow-ups(at baseline, 3-month and 9-month follow-ups)
- Concentration of short chain fatty acid in stool samples at baseline, 3-month and 9-month follow-ups(at baseline, 3-month and 9-month follow-ups)
- 3-day food record at baseline, 3-month and 9-month follow-ups(at baseline, 3-month and 9-month follow-ups)
- C-reactive protein level at baseline, 3-month and 9-month follow-ups(at baseline, 3-month and 9-month follow-ups)
- IL6 level at baseline, 3-month and 9-month follow-ups(at baseline, 3-month and 9-month follow-ups)
- Shannon diversity index of oral and gut microbiota at baseline, 3-month and 9-month follow-ups(at baseline, 3-month and 9-month follow-ups)
- Chinese version of Chrono-nutrition Profile Questionnaire at baseline, 3-month and 9-month follow-ups(at baseline, 3-month and 9-month follow-ups)
- Chinese version of Munich Chronotype Questionnaire at baseline, 3-month and 9-month follow-ups(at baseline, 3-month and 9-month follow-ups)
- Chinese version of international physical activity questionnaire short form at baseline, 3-month and 9-month follow-ups(at baseline, 3-month and 9-month follow-ups)
研究者
Prof. Walter Y.H. Lam
Clinical Associate Professor
The University of Hong Kong