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
Trial ID: NCT06980701
Status: RECRUITING
Study type: INTERVENTIONAL
Phase: NA
Start date: 2025-04-12
Completion date: 2026-04-18
Sponsor: The University of Hong Kong
Conditions: Gum Disease; Prediabetes
Interventions: AI OHI group; Dental professionals OHI group
Locations: Prince Philip Dental Hospital
Countries: Hong Kong
Enrollment: 148
Age range: 18 Years - None
Sex: ALL

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.

Eligibility criteria:
Inclusion Criteria:

* \- 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.

Exclusion Criteria:

* \- 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.

Outcomes:
Gum inflammation at baseline; Gingival health at baseline; Oral hygiene status at baseline; HbA1c level at baseline; FPG level at baseline; 2-h PG during 75-g OGTT level at baseline; Gum inflammation at 3-month; Gingival health at 3-month; Oral hygiene status at 3-month; HbA1c level at 3-month; FPG level at 3-month; 2-h PG during 75-g OGTT level at 3-month; Gum inflammation at 9-month; Gingival health at 9-month; Oral hygiene status at 9-month; HbA1c level at 9-month; FPG level at 9-month; 2-h PG during 75-g OGTT level at 9-month