NCT07809477Not yet recruiting
Integrated Diabetes and Oral Health Care in Oman
Cost-Effectiveness and Implementation of Integrated Diabetes-Oral Health Care in Oman: A Health Belief Model-Based Intervention to Enhance Clinical, Behavioral, and Exploratory Oral Microbiome in Health System Outcomes in Type 2 Diabetes
Source: ClinicalTrials.gov · Last updated 9 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 290 (estimated)
- First submitted
- 16 Aug 2026
- Start date
- 1 Sept 2026
- Primary completion date
- 1 Sept 2028
- Lead sponsor
- Oman Ministry of Health
- Diseases
- Type 1 diabetes, Type 2 diabetes
- NCT number
- NCT07809477
What you commit to
- Study type: Interventional
- Planned participants: 290
- From 1 Sept 2026 to the primary completion date, 1 Sept 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Severe periodontitis requiring immediate surgical intervention.
Other illness
- Cognitive impairment or severe mental illness limiting participation.
- Active systemic infectious diseases such as tuberculosis, syphilis, or HIV.
- Participation in another diabetes or oral health intervention trial.
Lab values
- Use of medications that may significantly affect glucose metabolism or gingival health, such as long-term systemic corticosteroids, immunosuppressants, phenytoin, or calcium channel blockers.
Other
- Pregnant or breastfeeding.
- Unable to comply with the follow-up schedule.
Who the study is looking for
- 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.
Age in the registry: 35 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.