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Integrated Diabetes and Oral Health Care in Oman

Not Yet RecruitingNA

Sponsor: Oman Ministry of Health

Conditions: Type 2 Diabetes Mellitus, Periodontitis, T2DM, Periodontal Disease, Type 2 Diabetes

Interventions: Health Belief Model-Based Integrated Diabetes-Oral Health Educational Intervention, Standard Diabetes Education and Routine Care

Type 2 diabetes mellitus (T2DM) and periodontal (gum) disease are closely related conditions that may negatively affect each other. However, oral health is not routinely integrated into diabetes self-management education. This study will evaluate whether a structured diabetes-oral health educational intervention based on the Health Belief Model can improve glycaemic control, periodontal health, self-management behaviours, and quality of life among adults with T2DM in Oman. This multicentre randomized controlled trial will include 290 adults with T2DM. Participants will be randomly assigned to either an intervention group or a control group. The intervention group will receive six individual, structured diabetes-oral health education sessions over 12 weeks in addition to usual care. The control group will continue to receive standard diabetes care and education. Participants will be followed for 12 months. The primary outcome is change in glycated haemoglobin (HbA1c) from baseline to 12 months. Secondary outcomes include periodontal health, diabetes and oral-health self-care behaviours, Health Belief Model constructs, quality of life, psychological well-being, diabetes distress, healthcare utilization, and healthcare costs. The study will also assess the cost-effectiveness of the intervention. Exploratory components will assess previously undiagnosed periodontal disease and examine associations between periodontal changes and the oral microbiome.

Eligibility overview

Sex: ALL

Age: 35 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Aged 35 years or older.
* Confirmed diagnosis of type 2 diabetes mellitus (T2DM), documented in the medical record for at least 12 months.
* Able to understand Arabic or English.
* Able to provide written informed consent.
* Able to attend the scheduled educational sessions and follow-up visits.

Exclusion Criteria:

* Pregnant or breastfeeding.
* Cognitive impairment or severe mental illness limiting participation.
* Active systemic infectious diseases such as tuberculosis, syphilis, or HIV.
* Use of medications that may significantly affect glucose metabolism or gingival health, such as long-term systemic corticosteroids, immunosuppressants, phenytoin, or calcium channel blockers.
* Severe periodontitis requiring immediate surgical intervention.
* Participation in another diabetes or oral health intervention trial.
* Unable to comply with the follow-up schedule.