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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe University of Hong Kong

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • AI OHI group

    Behavioral

    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

  • Human-OHI group

    Behavioral

    The 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

    Behavioral

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

Treatment groups

105 Participants
are divided into 3 treatment groups
Group A: AI OHI groupExperimental treatment 1 intervention
Group B: Human-OHI group:Experimental treatment 1 intervention
Group C: Control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
baseline
2

FPG level at baseline

Glycaemic level at baseline is evaluated by FPG (fasting plasma glucose level that measures the blood sugar levels).

Time frame
baseline
3

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)

Time frame
baseline
4

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

Secondary outcomes

1

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

Time frame
baseline, 6-month and 12-month follow-ups
2

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

Time frame
baseline, 6-month and 12-month follow-ups
3

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

Time frame
baseline, 6-month and 12-month follow-ups
4

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

Time frame
baseline, 6-month and 12-month follow-ups

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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