About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
AI OHI group
BehavioralThe 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
Human-OHI group
BehavioralThe 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.
Control group
Behavioralpatients will receive standard oral hygiene instruction on the adequacy of patients' home care
Treatment groups
Trial outcomes
Primary outcomes
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).
FPG level at 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
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
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)
Secondary outcomes
Blood pressure at baseline, 6-month and 12-month follow-ups
Blood pressure will be assessed at baseline, 6-month and 12-month follow-ups
Estimated glomerular filtration rate at baseline, 6-month and 12-month follow-ups
Estimated glomerular filtration rate will be assessed at baseline, 6-month and 12-month follow-ups
Urine analysis at baseline, 6-month and 12-month follow-ups
Urine analysis will be assessed at baseline, 6-month and 12-month follow-ups
Full lipids profile at baseline, 6-month and 12-month follow-ups
Full lipids profile will be assessed at baseline, 6-month and 12-month follow-ups
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: