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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe University of Hong Kong

About this trial

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.

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 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.

Disqualifiers

- 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.

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

  • Dental professionals OHI group

    Behavioral

    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.

Treatment groups

148 Participants
are divided into 2 treatment groups
Group A: AI OHI groupExperimental treatment 1 intervention
Group B: Dental professionals OHI groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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
3

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
4

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

Secondary outcomes

1

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

Time frame
at baseline, 3-month and 9-month follow-ups
2

IL6 level at baseline, 3-month and 9-month follow-ups

Inflammatory markers, i.e., IL6 from serum, saliva and plaque samples (pg/mL) will be assessed at baseline, 3-month and 9-month follow-ups

Time frame
at baseline, 3-month and 9-month follow-ups
3

IL8 level at baseline, 3-month and 9-month follow-ups

Inflammatory markers, i.e., IL8 from serum, saliva and plaque samples (pg/mL) will be assessed at baseline, 3-month and 9-month follow-ups

Time frame
at baseline, 3-month and 9-month follow-ups
4

Body weight at baseline, 3-month and 9-month follow-ups

Body weight (measured with standard procedures, in kilograms) will be assessed at baseline, 3-month and 9-month follow-ups

Time frame
at baseline, 3-month and 9-month follow-ups

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.