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

NCT06980701 | Recruiting

• 1 other identifier: UW 24-658
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Gum Disease; Prediabetes

Keywords

gum disease; prediabetes; oral health; oral hygiene

Outcome Measures

Primary Outcomes (18)

• 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)

  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)

  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)

  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)

  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)

  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)

  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

  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

  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

  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)

  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)

  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)

  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

  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

  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

  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)

  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)

  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)

  9-month

Secondary Outcomes (11)

• C-reactive protein level at baseline, 3-month and 9-month follow-ups

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

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

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

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

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

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

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

• Percentage body fat at baseline, 3-month and 9-month follow-ups

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

Study Arms (2)

AI OHI group

EXPERIMENTAL

Personalized oral hygiene instructions provided by AI on the adequacy of patients' home care.

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

Behavioral: Dental professionals OHI group

Interventions

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

Also known as: AI

AI OHI group

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.

Also known as: conventional OHI

Dental professionals OHI group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Prince Philip Dental Hospital

Hong Kong, Sai Ying Pun, 999077, Hong Kong

RECRUITING

MeSH Terms

Conditions

Gingival Diseases; Prediabetic State

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Walter Y.H. Lam, Prof.

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Walter Y.H. Lam, Prof.

CONTACT

(852) 28590306; retlaw@hku.hk

Mandy M Ho, Prof.

CONTACT

(852) 39176973; mandyho1@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: May 1, 2025
• First Posted: May 20, 2025
• Study Start: April 12, 2025
• Primary Completion: April 18, 2026
• Study Completion: April 18, 2026
• Last Updated: December 3, 2025

Record last verified: 2025-05

Locations

HK (1)