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Gum DiseaseNCT07841717

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 study testing AI OHI group and Human-OHI group in people with Gum Disease and Diabetes, run by The University of Hong Kong.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Gum Disease, Diabetes
What is being tested?
AI OHI group and Human-OHI group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
105 participants
Where
No sites listed yet
Study dates
1 Oct 2026to 30 Sep 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Walter Y.H. Lam, Prof. contact

(852) 28590306

retlaw@hku.hk

About this study

Official title: 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

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.

Read the detailed description

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.

There has been growing interest in an alternative pathway known as the enteral route. Recent research has demonstrated the interconnectedness of the oral cavity and gastrointestinal tract, highlighting their mutual influence, particularly in terms of microbiological aspects. The discovery that even healthy individuals harbour habitual oral microbes in their feces has contradicted the traditional belief that multiple barriers were responsible for maintaining the segregation of oral and gut microbiota. One possible explanation is the transfer of oral bacteria and their by-products from the mouth to the digestive tract through swallowing. Upon reaching the gut, these bacteria may induce inflammation, disrupt the gut microbiota, and generate metabolites that facilitate pathological processes. Studies have revealed the presence of circadian rhythms in both oral and gut microbiota in humans, which suggests that, in addition to dietary choices, the timing of food consumption could also impact the composition of oral and gut microbiota.

The relation between oral health and diabetes management has long been under-appreciated. People with diabetes have a 2-3-fold greater risk for periodontitis compared to people without diabetes, but also a higher incidence of caries due to dry mouth. The progression and severity of periodontitis are also greater in people with poorly controlled diabetes. According to the American Academy of Periodontology, 50% of diabetics up to the age of 35 suffer from periodontal disease, a figure that rises to 80% at the age of 45-54 years, compared to 60% in the healthy population. A growing body of data indicates that oral inflammation has an impact on general diseases.

It was reported that over 85% Chinese adults suffered from periodontal disease. A previous review considered the relationship between periodontitis and T2DM as bidirectional, with diabetes leading to increased risk for periodontitis, and periodontal inflammation negatively affecting glycaemic control. A number of studies revealed correlations of periodontal diseases with impaired fasting glucose, impaired glucose tolerance and HbA1c level. Poor oral hygiene is the most important cause of periodontal disease. Self-reported measures of oral hygiene have been associated with periodontal disease.

Unfortunately, the majority of diabetic patients are unaware of the connection between diabetes and their oral health. There is a need for educational programs for diabetic patients that emphasize this relationship, explain the unpleasant effects of poor oral health on the patient's glycaemic control, and recommend behaviours that promote good oral health, but also overall wellbeing and a better quality of life.

It has been suggested that oral hygiene education and oral health behaviour change may have a positive impact on periodontal condition and systemic inflammatory status. Oral hygiene instruction (OHI) ais regarded as an important treatment procedure for dental patients. Despite growing evidence on the benefit of non-surgical periodontal treatment (NSPT) in improving periodontal inflammation, facilitating glycaemic control, and reducing metabolic and proinflammatory markers in diabetic patients, data in the effectiveness of OHI in diabetic patients with remain scarce.

The American Academy of Periodontology treatment guidelines stress that periodontal health should be achieved in the least invasive and most cost-effective manner. This is often accomplished through NSPT, including OHI, scaling and root planning of the root surface to remove plaque, calculus and bacterial toxins from deep periodontal pockets. Adjunctive therapy, such as antimicrobial therapy and host modulation are incorporated into the treatment regimen as required on a case-by-case basis. Intervention trials have suggested that there was an improvement in glycaemic control in people with diabetes following non-surgical periodontal therapy.

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 our team found that AI-based mHealth for oral hygiene and gum disease monitoring showed clinical effectiveness across different clinical scenarios. Our 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). Our 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, we have tested that the accuracy of colour captured by a smartphone is comparable to that captured by a professional single-lens reflective camera. Our team already have applied our AI-powered smartphone photography among 38 older adults in 5 day-care centres of Hong Kong to test their 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 OHI closely to the patients to maintain periodontal health and consequently diabetic control.

Being tested
AI OHI group, Human-OHI group, Control group
Keywords
gum disease, diabetes, oral hygiene, HbA1c
Medical subject headings
Gingival Diseases, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AI OHI groupBehavioural

    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 groupBehavioural

    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 groupBehavioural

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

Study groups in NCT07841717
Study groupRoleWhat they receive
AI OHI groupExperimentalAI-OHI group: personalized oral hygiene instructions provided by AI on the adequacy of patients' home care
Receives: Behavioral: AI OHI group
Human-OHI group:Experimentalpersonalized oral hygiene instructions provided by dental professionals on the adequacy of patients' home care
Receives: Behavioral: Human-OHI group
Control groupActive comparatorpatients will receive standard oral hygiene instruction on the adequacy of patients' home care
Receives: Behavioral: Control group

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: baseline

  2. FPG level at baseline

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

    Measured: 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)

    Measured: 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)

    Measured: baseline

  5. 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)

    Measured: baseline

  6. 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)

    Measured: baseline

  7. HbA1c level at 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).

    Measured: 6 month

  8. FPG level at 6-month

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

    Measured: 6 month

  9. 2-h PG during 75-g OGTT level at 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)

    Measured: 6 month

  10. Gum inflammation at 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

    Measured: 6 month

  11. Gingival health at 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

    Measured: 6 month

  12. Oral hygiene status at 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

    Measured: 6 month

  13. HbA1c level at 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)

    Measured: 12 month

  14. FPG level at 12-month

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

    Measured: 12 month

  15. 2-h PG during 75-g OGTT level at 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).

    Measured: 12 month

  16. Gum inflammation at 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

    Measured: 12 month

  17. Gingival health at 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

    Measured: 12 month

  18. Oral hygiene status at 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

    Measured: 12 month

Secondary outcomes (12)
  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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: baseline, 6-month and 12-month follow-ups

  5. Body weight at baseline, 6-month and 12-month follow-ups

    Body weight (measured with standard procedures, in kilograms) will be assessed at baseline, 6-month and 12-month follow-ups

    Measured: baseline, 6-month and 12-month follow-ups

  6. Body mass index at baseline, 6-month and 12-month follow-ups

    Body mass index will be assessed at baseline, 6-month and 12-month follow-ups

    Measured: baseline, 6-month and 12-month follow-ups

  7. Shannon diversity index of oral and gut microbiota at baseline, 6-month and 12-month follow-ups

    Oral and gut microbiota will be analyzed from stool, plaque and salivary sample. The diversity of the oral and gut microbiota samples will be measured by the Shannon diversity index.

    Measured: baseline, 6-month and 12-month follow-ups

  8. Lifestyle assessment at baseline, 6-month and 12-month follow-ups

    Lifestyle assessment including dietary intake, smoke and drinking habits, physical activity, will be assessed at baseline, 6-month and 12-month follow-ups

    Measured: baseline, 6-month and 12-month follow-ups

  9. Oral health-related quality of life questionnaire at baseline, 6-month and 12-month follow-ups

    Oral health-related quality of life (OHRQoL) questionnaire will be evaluated at baseline, 6-month and 12-month follow-ups

    Measured: baseline, 6-month and 12-month follow-ups

  10. Oral Health Impact Profile at baseline, 6-month and 12-month follow-ups

    Oral Health Impact Profile (OHIP-14) will be assessed at baseline, 6-month and 12-month follow-ups

    Measured: baseline, 6-month and 12-month follow-ups

  11. Oral Health Knowledge, attitude and behavior at baseline, 6-month and 12-month follow-ups

    Oral Health Knowledge, attitude and behavior will be assessed at baseline, 6-month and 12-month follow-ups

    Measured: baseline, 6-month and 12-month follow-ups

  12. Oral hygiene self-efficacy and self-esteem at baseline, 6-month and 12-month follow-ups

    Oral hygiene self-efficacy and self-esteem will be assessed at baseline, 6-month and 12-month follow-ups

    Measured: baseline, 6-month and 12-month follow-ups

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Sep 2026
  2. Study start1 Oct 2026 (estimated)
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion30 Sep 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
105 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07841717
Sponsor's protocol ID
UW 26-112
Other IDs
UW 26-112
Status last verified
Sep 2026
First submitted
19 Sep 2026
Last updated
1 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing AI OHI group and Human-OHI group in people with Gum Disease and Diabetes, run by The University of Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Walter Y.H. Lam, Prof. ((852) 28590306, retlaw@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HbA1c level at baseline (time frame: baseline). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.

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