Gum DiseaseNCT06980701
Improving Oral and Systemic Health in Individuals With Prediabetes Through Personalized Oral Hygiene Advice Provided by Dentists or by AI
A study testing AI OHI group and Dental professionals OHI group in people with Gum Disease and Prediabetes, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gum Disease, Prediabetes
- What is being tested?
- AI OHI group and Dental professionals OHI group
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteHong Kong
- Study dates
- 12 Apr 2025to 18 Apr 2026
- 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 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.
- - Subjects who can speak, read, or understand Cantonese to complete the satisfaction 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 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Prince Philip Dental Hospital
Hong Kong, Sai Ying Pun, 999077
Walter Lam, Prof., +852 28590306, retlaw@hku.hk
About this study
Official title: Improving Oral and Systemic Health in Individuals With Prediabetes Through Personalized Oral Hygiene Advice Provided by Dentists or by Artificial Intelligence: A Randomized Clinical 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.
Read the detailed description
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. The relation between oral health and prediabetes management has long been under-appreciated. People with prediabetes have a 2-3-fold greater risk for periodontitis compared to people without prediabetes. The progression and severity of periodontitis are also greater in prediabetic patients. According to the National Health and Nutrition Examination Survey, the severity of periodontitis is positively associated with the risk as well as the prevalence of prediabetes. A growing body of data indicates that oral inflammation has an impact on general diseases. 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.
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 investigators' team found that AI-based mHealth for oral hygiene and gum disease monitoring showed clinical effectiveness across different clinical scenarios. The investigators' 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). The 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, the investigators have tested that the accuracy of colour captured by a smartphone is comparable to that captured by a professional single-lens reflective camera. The investigators' team already have applied the AI-powered smartphone photography among 38 older adults in 5 day-care centres of Hong Kong to test participants' 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 oral health instruction (OHI) closely to the patients to maintain periodontal health and consequently prediabetic control.
In this study, the hypothesis is that the use of AI can improve home care, thereby enhancing both gum health and systemic health, similar to human dental professionals.
- Conditions
- Gum Disease, Prediabetes
- Being tested
- AI OHI group, Dental professionals OHI group
- Keywords
- gum disease, prediabetes, oral health, oral hygiene
- Medical subject headings
- Gingival Diseases, Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI OHI groupBehavioural
Also called AI
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 groupBehavioural
Also called conventional OHI
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.
| Study group | Role | What they receive |
|---|---|---|
| AI OHI group | Experimental | Personalized oral hygiene instructions provided by AI on the adequacy of patients' home care. Receives: Behavioral: AI OHI group |
| Dental professionals OHI group | Active comparator | Personalized oral hygiene instructions provided by a dental professional on the adequacy of patients' home care Receives: Behavioral: Dental professionals OHI group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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
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
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)
Measured: baseline
FPG level at baseline
Glycaemic level at baseline is evaluated by FPG (fasting plasma glucose level that measures the blood sugar levels). Prediabetes is defined as 100-125 mg/dL (5.6-6.9 mmol/L)
Measured: baseline
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). Prediabetes is defined as 2-h PG during 75-g OGTT of 140-199 mg/dL (7.8-11.0 mmol/L)
Measured: baseline
Gum inflammation at 3-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 3-month follow up
Measured: 3-month
Gingival health at 3-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 3-month follow-up
Measured: 3-month
Oral hygiene status at 3-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 3-month follow-up
Measured: 3-month
HbA1c level at 3-month
Glycaemic level at 3-month follow-up 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)
Measured: 3-month
FPG level at 3-month
Glycaemic level at 3-month follow-up is evaluated by FPG (fasting plasma glucose level that measures the blood sugar levels). Prediabetes is defined as 100-125 mg/dL (5.6-6.9 mmol/L)
Measured: 3-month
2-h PG during 75-g OGTT level at 3-month
Glycaemic level at 3-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). Prediabetes is defined as 2-h PG during 75-g OGTT of 140-199 mg/dL (7.8-11.0 mmol/L)
Measured: 3-month
Gum inflammation at 9-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 9-month follow up
Measured: 9-month
Gingival health at 9-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 9-month follow-up
Measured: 9-month
Oral hygiene status at 9-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 9-month follow-up
Measured: 9-month
HbA1c level at 9-month
Glycaemic level at 9-month follow-up 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)
Measured: 9-month
FPG level at 9-month
Glycaemic level at 9-month follow-up is evaluated by FPG (fasting plasma glucose level that measures the blood sugar levels). Prediabetes is defined as 100-125 mg/dL (5.6-6.9 mmol/L)
Measured: 9-month
2-h PG during 75-g OGTT level at 9-month
Glycaemic level at 9-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). Prediabetes is defined as 2-h PG during 75-g OGTT of 140-199 mg/dL (7.8-11.0 mmol/L)
Measured: 9-month
Secondary outcomes (11)
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
Measured: at baseline, 3-month and 9-month follow-ups
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
Measured: at baseline, 3-month and 9-month follow-ups
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
Measured: at baseline, 3-month and 9-month follow-ups
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
Measured: at baseline, 3-month and 9-month follow-ups
Percentage body fat at baseline, 3-month and 9-month follow-ups
Percentage body fat (using bioelectrical impedance analysis, %) will be assessed at baseline, 3-month and 9-month follow-ups
Measured: at baseline, 3-month and 9-month follow-ups
Shannon diversity index of oral and gut microbiota at baseline, 3-month and 9-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: at baseline, 3-month and 9-month follow-ups
Concentration of short chain fatty acid in stool samples at baseline, 3-month and 9-month follow-ups
Fecal metabolites will be measured through the concentration of short chain fatty acid in stool samples
Measured: at baseline, 3-month and 9-month follow-ups
3-day food record at baseline, 3-month and 9-month follow-ups
Dietary intake will be assessed using a 3-day food record to determine meal patterns, including macronutrient intake, energy intake, and meal timing
Measured: at baseline, 3-month and 9-month follow-ups
Chinese version of Chrono-nutrition Profile Questionnaire at baseline, 3-month and 9-month follow-ups
Chrono-nutrition behaviors will be evaluated using the Chinese version of the Chrono-nutrition Profile Questionnaire (CP-Q), which includes six distinct aspects: breakfast skipping, timing of the largest meal, evening eating habits, evening latency, nighttime eating behaviors, and eating window.
Measured: at baseline, 3-month and 9-month follow-ups
Chinese version of Munich Chronotype Questionnaire at baseline, 3-month and 9-month follow-ups
Chronotype will be assessed by Chinese version of Munich Chronotype Questionnaire (MCTQ). The computed variables of workdays and work-free days from this questionnaire include sleep onset (SOw, SOf, hh:mm), local time of getting out of bed (GUw, GUf, hh:mm), sleep duration (SDw, SDf, hh:mm), total time in bed (TBTw, TBTf, hh:mm), mid-sleep (MSW, MSF, hh:mm). The computation of the variables include: Average weekly sleep duration (hh:mm) =(SDw x WD + SDf x FD)/7, Chronotype (hh:mm) =If SDf ≤ SDw: MSF; If SDf > SDw: MSF - (SDf - SDweek)/2, Weekly sleep loss (hh:mm) = If SDweek > SDw: (SDweek - SDw) x WD; If SDweek ≤ SDw: (SDweek - SDf) x FD, Relative social jetlag (hh:mm) = MSF - MSW, Absolute social jetlag (hh:mm) = | MSF - MSW |, Average weekly light exposure (hh:mm) = (LEw x WD + LEf x FD)/7
Measured: at baseline, 3-month and 9-month follow-ups
Chinese version of international physical activity questionnaire short form at baseline, 3-month and 9-month follow-ups
Physical activity (PA) levels will be evaluated by a Chinese version of international physical activity questionnaire short form (IPAQ). Total PA (min/wk) = 2x time spent on vigorous + moderate + walking, MET (Metabolic Equivalent of Task, min/wk) = 8 x vigorous +4x moderate + 3.3 x walking
Measured: at baseline, 3-month and 9-month follow-ups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2025
- Study start12 Apr 2025
- Primary completion18 Apr 2026 (estimated)
- Study completion18 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gum DiseaseStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 148 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Walter Y.H. Lam, The University of Hong Kong
- Investigators
- Walter Y.H. Lam, Prof., Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06980701
- Sponsor's protocol ID
- UW 24-658
- Status last verified
- May 2025
- First submitted
- 1 May 2025
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Oral and Systemic Health in Individuals With Prediabetes Through Personalized Oral Hygiene Advice Provided by Dentists or by Artificial Intelligence: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06980701
- Acronym / sponsor ID
- UW 24-658
- Conditions
- Gum Disease, Prediabetes
- Keywords
- gum disease, prediabetes, oral health, oral hygiene
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 148 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 12 Apr 2025 (actual)
- Primary completion
- 18 Apr 2026 (estimated)
- Study completion
- 18 Apr 2026 (estimated)
- First posted
- 20 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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. The relation between oral health and prediabetes management has long been under-appreciated. People with prediabetes have a 2-3-fold greater risk for periodontitis compared to people without prediabetes. The progression and severity of periodontitis are also greater in prediabetic patients. According to the National Health and Nutrition Examination Survey, the severity of periodontitis is positively associated with the risk as well as the prevalence of prediabetes. A growing body of data indicates that oral inflammation has an impact on general diseases. 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.
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 investigators' team found that AI-based mHealth for oral hygiene and gum disease monitoring showed clinical effectiveness across different clinical scenarios. The investigators' 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). The 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, the investigators have tested that the accuracy of colour captured by a smartphone is comparable to that captured by a professional single-lens reflective camera. The investigators' team already have applied the AI-powered smartphone photography among 38 older adults in 5 day-care centres of Hong Kong to test participants' 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 oral health instruction (OHI) closely to the patients to maintain periodontal health and consequently prediabetic control.
In this study, the hypothesis is that the use of AI can improve home care, thereby enhancing both gum health and systemic health, similar to human dental professionals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AI OHI group | Experimental | Behavioral: AI OHI groupPersonalized oral hygiene instructions provided by AI on the adequacy of patients' home care. |
| Dental professionals OHI group | Active comparator | Behavioral: Dental professionals OHI groupPersonalized oral hygiene instructions provided by a dental professional on the adequacy of patients' home care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- - 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.
- - Subjects who can speak, read, or understand Cantonese to complete the satisfaction questionnaire.
Key exclusion criteria (4 listed)
- - 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AI OHI groupAlso: AIThe 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 | Behavioural | AI OHI group |
| Dental professionals OHI groupAlso: conventional OHIll 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. | Behavioural | Dental professionals OHI group |
Primary outcome
Gum inflammation at baseline
Time frame: 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
Time frame: 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
Time frame: 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 baseline
Time frame: 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)
FPG level at baseline
Time frame: baseline
Glycaemic level at baseline is evaluated by FPG (fasting plasma glucose level that measures the blood sugar levels). Prediabetes is defined as 100-125 mg/dL (5.6-6.9 mmol/L)
2-h PG during 75-g OGTT level at baseline
Time frame: 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). Prediabetes is defined as 2-h PG during 75-g OGTT of 140-199 mg/dL (7.8-11.0 mmol/L)
Gum inflammation at 3-month
Time frame: 3-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 3-month follow up
Gingival health at 3-month
Time frame: 3-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 3-month follow-up
Oral hygiene status at 3-month
Time frame: 3-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 3-month follow-up
HbA1c level at 3-month
Time frame: 3-month
Glycaemic level at 3-month follow-up 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)
FPG level at 3-month
Time frame: 3-month
Glycaemic level at 3-month follow-up is evaluated by FPG (fasting plasma glucose level that measures the blood sugar levels). Prediabetes is defined as 100-125 mg/dL (5.6-6.9 mmol/L)
2-h PG during 75-g OGTT level at 3-month
Time frame: 3-month
Glycaemic level at 3-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). Prediabetes is defined as 2-h PG during 75-g OGTT of 140-199 mg/dL (7.8-11.0 mmol/L)
Gum inflammation at 9-month
Time frame: 9-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 9-month follow up
Gingival health at 9-month
Time frame: 9-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 9-month follow-up
Oral hygiene status at 9-month
Time frame: 9-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 9-month follow-up
HbA1c level at 9-month
Time frame: 9-month
Glycaemic level at 9-month follow-up 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)
FPG level at 9-month
Time frame: 9-month
Glycaemic level at 9-month follow-up is evaluated by FPG (fasting plasma glucose level that measures the blood sugar levels). Prediabetes is defined as 100-125 mg/dL (5.6-6.9 mmol/L)
2-h PG during 75-g OGTT level at 9-month
Time frame: 9-month
Glycaemic level at 9-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). Prediabetes is defined as 2-h PG during 75-g OGTT of 140-199 mg/dL (7.8-11.0 mmol/L)
11 secondary outcomes
C-reactive protein level at baseline, 3-month and 9-month follow-ups
Time frame: at baseline, 3-month and 9-month follow-ups
IL6 level at baseline, 3-month and 9-month follow-ups
Time frame: at baseline, 3-month and 9-month follow-ups
IL8 level at baseline, 3-month and 9-month follow-ups
Time frame: at baseline, 3-month and 9-month follow-ups
Body weight at baseline, 3-month and 9-month follow-ups
Time frame: at baseline, 3-month and 9-month follow-ups
Percentage body fat at baseline, 3-month and 9-month follow-ups
Time frame: at baseline, 3-month and 9-month follow-ups
Shannon diversity index of oral and gut microbiota at baseline, 3-month and 9-month follow-ups
Time frame: at baseline, 3-month and 9-month follow-ups
Concentration of short chain fatty acid in stool samples at baseline, 3-month and 9-month follow-ups
Time frame: at baseline, 3-month and 9-month follow-ups
3-day food record at baseline, 3-month and 9-month follow-ups
Time frame: at baseline, 3-month and 9-month follow-ups
Chinese version of Chrono-nutrition Profile Questionnaire at baseline, 3-month and 9-month follow-ups
Time frame: at baseline, 3-month and 9-month follow-ups
Chinese version of Munich Chronotype Questionnaire at baseline, 3-month and 9-month follow-ups
Time frame: at baseline, 3-month and 9-month follow-ups
Chinese version of international physical activity questionnaire short form at baseline, 3-month and 9-month follow-ups
Time frame: at baseline, 3-month and 9-month follow-ups
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Walter Y.H. Lam, Prof. principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI OHI group and Dental professionals OHI group in people with Gum Disease and Prediabetes, run by The University of Hong Kong at 1 site in 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 6 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Gum inflammation 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 3 Dec 2025.