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临床试验/NCT07841717
NCT07841717尚未招募不适用

Effectiveness of Personalized Oral Hygiene Advice Delivered by Artificial Intelligence or Dental Professionals Versus Standard Oral Hygiene Advice on Oral and Systemic Health in Community-based Type II Diabetes Patients: A Randomized Controlled Trial

The University of Hong Kong0 个研究点目标入组 105 人开始时间: 2026年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
105
主要终点
HbA1c level at baseline

研究概览

简要总结

Diabetes is a systemic condition characterized by elevated blood glucose levels 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 by maintaining oral hygiene improves blood glucose levels and reduces long-term complications. However, close supervision of good oral hygiene through 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 and standardised oral health instructions.

详细描述

Diabetes is a systemic condition characterized by elevated blood glucose levels 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). We hypothesize that the use of AI can improve home care, thereby enhancing both gum health and systemic health, compared to the absence of AI in chronic disease healthcare.

Diabetes is a serious public health problem and accounts for 9% of all deaths worldwide. According to the World Health Organization (WHO), by 2030, the number of diabetics will increase to at least 366 million worldwide. In Europe, the diabetic population is estimated at 66 million, a number that will rise to 89 million by 2045. However, these figures are not as dramatic as in America and many other low- and middle-income countries. Diabetes has become a major public health problem in China, increasing rapidly in last decades. About 90% of diabetes patients have type 2 diabetes mellitus (T2DM ), which causes a range of health complications, such as eye, mouth, and skin infections, cardiovascular diseases, blindness, and kidney failure, and can lead to lower limb amputation, reducing patients' quality of life and imposing a burden on them, their families, and the wider society. The main predisposing factors for T2DM are the existence of prediabetes, obesity, age ≥ 45 years, a family history of T2DM in first-degree relatives, a lack of physical exercise, the onset of gestational diabetes or the birth of a new-born weighing > 4 kg, the presence of non-alcoholic fatty liver disease, and smoking.

Prevention of T2DM is a major challenge worldwide, as both its prevalence and incidence are increasing rapidly. The main symptoms of T2DM are typical and common to all types; they include polyuria, polydipsia, polyphagia, dry mouth and/or dry skin, excessive fatigue, blurred vision, and trauma, such as cuts and bruises that are slow to heal.

Chronic oral diseases are significantly more common and more severe in diabetic patients. In addition to gingival infection and periodontal inflammation, there may be complications of implants, caries, dry mouth, bacterial and fungal infections, oral malodour, and slow healing of wounds from dental treatments. In addition, the Candida species are seen more often in people with diabetes than in healthy people. Periodontitis is the main and most important complication of T2DM, with a prevalence of 7 in 10 adults having some type of periodontal disease, and almost half of this population having moderate or severe periodontitis. Age, sex, education level, family income, smoking, oral hygiene-related behaviours, T2DM, and other comorbidities, such as some autoimmune diseases, have been identified as important potential risk factors for periodontitis in many studies.

The findings of the studies also show that T2DM is associated with an increased risk of tooth loss because of periodontal disease, possibly through the mechanism of inflammation: directly due to an inflammatory response of the gums and indirectly due to the creation of a substrate resulting from reduced saliva production secondary to medication. In particular, periodontal disease is caused by changes in collagen metabolism-and consequently, in periodontal fibers-and by the presence of microbial plaque and poor hygiene in most diabetics, resulting in resorption of the gums, the underlying connective tissue, and the jawbones, leading to loss of teeth.

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 are with T2DM state with impaired HbA1c > 6.4%, or impaired fasting plasma glucose level > 6.9 mmol/L or impaired plasma glucose level after 2h OGTT > 11.0 mmol/L.
  • •Subjects who can speak, read, or understand Cantonese to complete the 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 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

Experimental

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)

Human-OHI group:

Experimental

personalized oral hygiene instructions provided by dental professionals on the adequacy of patients' home care

干预措施: Human-OHI group (Behavioral)

Control group

Active Comparator

patients will receive standard oral hygiene instruction on the adequacy of patients' home care

干预措施: Control group (Behavioral)

结局指标

主要结局

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).

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).

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)

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 6-month

时间窗: 6 month

Glycaemic level at 6-month follow-up is evaluated by HbA1c level (glycated haemoglobin that measures glycaemic control over the past 2-3 months).

FPG level at 6-month

时间窗: 6 month

Glycaemic level at 6-month follow-up is evaluated by FPG (fasting plasma glucose level that measures the blood sugar levels).

2-h PG during 75-g OGTT level at 6-month

时间窗: 6 month

Glycaemic level at 6-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)

Gum inflammation at 6-month

时间窗: 6 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 6-month follow up

Gingival health at 6-month

时间窗: 6 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 6-month follow-up

Oral hygiene status at 6-month

时间窗: 6 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 6-month follow-up

HbA1c level at 12-month

时间窗: 12 month

Glycaemic level at 12-month follow-up is evaluated by HbA1c level (glycated haemoglobin that measures glycaemic control over the past 2-3 months)

FPG level at 12-month

时间窗: 12 month

Glycaemic level at 12-month follow-up is evaluated by FPG (fasting plasma glucose level that measures the blood sugar levels)

2-h PG during 75-g OGTT level at 12-month

时间窗: 12 month

Glycaemic level at 12-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).

Gum inflammation at 12-month

时间窗: 12 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 12-month follow up

Gingival health at 12-month

时间窗: 12 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 12-month follow-up

Oral hygiene status at 12-month

时间窗: 12 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 12-month follow-up

次要结局

  • Blood pressure at baseline, 6-month and 12-month follow-ups(baseline, 6-month and 12-month follow-ups)
  • Estimated glomerular filtration rate at baseline, 6-month and 12-month follow-ups(baseline, 6-month and 12-month follow-ups)
  • Urine analysis at baseline, 6-month and 12-month follow-ups(baseline, 6-month and 12-month follow-ups)
  • Full lipids profile at baseline, 6-month and 12-month follow-ups(baseline, 6-month and 12-month follow-ups)
  • Body weight at baseline, 6-month and 12-month follow-ups(baseline, 6-month and 12-month follow-ups)
  • Body mass index at baseline, 6-month and 12-month follow-ups(baseline, 6-month and 12-month follow-ups)
  • Shannon diversity index of oral and gut microbiota at baseline, 6-month and 12-month follow-ups(baseline, 6-month and 12-month follow-ups)
  • Lifestyle assessment at baseline, 6-month and 12-month follow-ups(baseline, 6-month and 12-month follow-ups)
  • Oral health-related quality of life questionnaire at baseline, 6-month and 12-month follow-ups(baseline, 6-month and 12-month follow-ups)
  • Oral Health Impact Profile at baseline, 6-month and 12-month follow-ups(baseline, 6-month and 12-month follow-ups)
  • Oral Health Knowledge, attitude and behavior at baseline, 6-month and 12-month follow-ups(baseline, 6-month and 12-month follow-ups)
  • Oral hygiene self-efficacy and self-esteem at baseline, 6-month and 12-month follow-ups(baseline, 6-month and 12-month follow-ups)

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

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