Type 2 Diabetes MellitusNCT07809477
Integrated Diabetes and Oral Health Care in Oman
A study testing Health Belief Model-Based Integrated Diabetes-Oral Health Educational Intervention and Standard Diabetes Education and Routine Care in people with Type 2 Diabetes Mellitus and Periodontitis, run by Oman Ministry of Health.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus, Periodontitis, T2DM
- What is being tested?
- Health Belief Model-Based Integrated Diabetes-Oral Health Educational Intervention and Standard Diabetes Education and Routine Care
- 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
- 290 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 1 Sep 2028
- 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 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
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.
Read the detailed description
Type 2 diabetes mellitus (T2DM) is an important public health problem in Oman. Periodontal disease is common among people with diabetes, and the relationship between diabetes and periodontal disease is bidirectional. Poor glycaemic control may contribute to periodontal inflammation, while periodontal inflammation may adversely affect metabolic control. Despite this relationship, diabetes education commonly focuses on glycaemic control and general diabetes self-management, with limited structured integration of oral-health education and behavioural approaches.
This study is a multicentre, two-arm randomized controlled trial designed to evaluate the effectiveness and cost-effectiveness of an integrated diabetes-oral health educational intervention based on the Health Belief Model (HBM). The study will recruit 290 adults with T2DM (145 participants per group) from participating diabetes clinics in Oman. Participants will be allocated to either the intervention group or the control group.
Participants assigned to the intervention group will receive six structured, individual HBM-based educational sessions, approximately 30 minutes each, delivered over 12 weeks. The intervention addresses diabetes and oral-health risk awareness; the severity and consequences of periodontal disease in people with T2DM; benefits of glycaemic control and oral hygiene; barriers to oral-health self-care and practical solutions; toothbrushing, interdental cleaning, and self-monitoring skills; and maintenance planning and relapse prevention. Sessions will include structured educational material, individualized advice, and goal-setting. Participants in the control group will continue to receive standard diabetes care and education.
Data will be collected at baseline and at 3, 6, and 12 months, as appropriate for each outcome. The primary outcome is change in HbA1c from baseline to 12 months. Secondary outcomes include periodontal clinical indicators, diabetes and oral-health self-management behaviours, HBM constructs, oral health-related and general health-related quality of life, psychological well-being, diabetes distress, healthcare utilization, and direct medical costs. An economic evaluation will assess the cost-effectiveness of the intervention.
As an exploratory component, participants will undergo periodontal assessment to estimate the prevalence of previously undiagnosed periodontal disease and examine its association with glycaemic control. The study will also explore associations between changes in periodontal status and oral microbiome profiles.
- Conditions
- Type 2 Diabetes Mellitus, Periodontitis, T2DM, Periodontal Disease, Type 2 Diabetes, Gum Inflammation
- Being tested
- Health Belief Model-Based Integrated Diabetes-Oral Health Educational Intervention, Standard Diabetes Education and Routine Care
- Keywords
- Health Belief Model, Oral health, Periodontal health, Oral microbiome, Diabetes self-management, Oral health behavior change, Glycemic control, Integrated diabetes-oral health care, Cost-effectiveness
- Medical subject headings
- Diabetes Mellitus, Type 2, Periodontitis, Periodontal Diseases, Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health Belief Model-Based Integrated Diabetes-Oral Health Educational InterventionBehavioural
Participants will receive an individualized Health Belief Model-based integrated diabetes-oral health educational intervention in addition to routine diabetes care. The intervention consists of six individual face-to-face educational sessions delivered over 12 weeks, with each session lasting approximately 30 minutes. The sessions address diabetes and oral health risk awareness, severity and consequences of periodontal disease, benefits of glycaemic control and oral hygiene, barriers to oral health self-care and practical solutions, brushing and interdental cleaning and self-monitoring skills, and maintenance planning and relapse prevention. Each session includes structured educational material, individualized advice, and simple goal-setting.
Standard Diabetes Education and Routine CareBehavioural
Participants will receive standard diabetes education and routine clinical care provided by existing diabetes services. Routine education includes advice on diet, medication adherence, physical activity, and blood glucose monitoring. Participants will not receive the structured Health Belief Model-based integrated diabetes-oral health educational intervention.
| Study group | Role | What they receive |
|---|---|---|
| Health Belief Model-Based Educational Intervention | Experimental | Participants allocated to this arm will receive an individualized Health Belief Model-based integrated diabetes-oral health educational programme in addition to routine diabetes care. The intervention consists of six individual face-to-face educational sessions delivered over 12 weeks, with each session lasting approximately 30 minutes. The programme addresses diabetes and oral health risk awareness, periodontal disease, benefits of glycaemic control and oral hygiene, barriers to oral health self-care, practical self-care skills, goal-setting, and maintenance planning. Receives: Behavioral: Health Belief Model-Based Integrated Diabetes-Oral Health Educational Intervention |
| Standard Diabetes Education and Routine Care | Active comparator | Participants allocated to this arm will continue to receive standard diabetes education and routine clinical care. This includes routine advice on diet, medication adherence, physical activity, and blood glucose monitoring. Participants in this arm will not receive the structured Health Belief Model-based integrated diabetes-oral health educational intervention. Receives: Behavioral: Standard Diabetes Education and Routine Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Glycated Hemoglobin (HbA1c) From Baseline to 12 Months
Change in HbA1c (%) from baseline to 12 months will be used to assess the effect of the intervention on glycaemic control. HbA1c will be measured using blood samples processed in a certified hospital laboratory. The between-group difference in change over time will be evaluated.
Measured: Baseline to 12 months
Secondary outcomes (5)
Change in Probing Pocket Depth (PPD)
Probing pocket depth will be measured in millimeters (mm) using a periodontal probe at six sites per tooth. Mean probing pocket depth will be calculated for each participant. Change in mean probing pocket depth from baseline will be compared between the intervention and control groups. Lower values indicate better periodontal health.
Measured: Baseline, 3 months, 6 months, and 12 months
Change in Diabetes Self-Management Behaviors
Diabetes self-management behaviors will be assessed using the Summary of Diabetes Self-Care Activities (SDSCA) questionnaire. The SDSCA assesses the frequency of diabetes self-care activities over the previous 7 days. Items are scored from 0 to 7 days, with higher scores indicating more frequent performance of the assessed self-care behavior. Change in SDSCA scores from baseline will be compared between the intervention and control groups.
Measured: Baseline, 3 months, 6 months, and 12 months
Healthcare Utilization
Healthcare utilization will be assessed as the number of healthcare services used by each participant during the study period, including relevant outpatient visits and other healthcare contacts recorded as part of the study. Healthcare utilization will be compared between the intervention and control groups. Higher values indicate greater healthcare resource utilization.
Measured: From baseline through 12 months
Change in Oral Health-Related Quality of Life Assessed Using the Oral Health Impact Profile-14 (OHIP-14)
Oral health-related quality of life will be assessed using the 14-item Oral Health Impact Profile (OHIP-14). Each item is scored from 0 (never) to 4 (very often), producing a total score ranging from 0 to 56. Higher total scores indicate poorer oral health-related quality of life. The change in total OHIP-14 score from baseline will be compared between the intervention and control groups.
Measured: Baseline, 3 months, 6 months, and 12 months
Direct Medical Costs
Direct medical costs associated with healthcare utilization will be estimated from the health-system perspective and reported in Omani Rial (OMR) per participant. Mean direct medical costs over the study period will be compared between the intervention and control groups. Higher values indicate greater healthcare costs.
Measured: Baseline through 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- 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
- Model description
- Two-arm, parallel-group randomized controlled trial comparing a structured Health Belief Model-based integrated diabetes-oral health educational intervention with standard diabetes care and education.
- Masking
- None (open label)
- Enrolment
- 290 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oman Ministry of Health
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07809477
- Sponsor's protocol ID
- MoH/CSR/26/32411
- Status last verified
- Aug 2026
- First submitted
- 16 Aug 2026
- Last updated
- 9 Sep 2026
- 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 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07809477
- Acronym / sponsor ID
- MoH/CSR/26/32411
- Conditions
- Type 2 Diabetes Mellitus, Periodontitis, T2DM, Periodontal Disease, Type 2 Diabetes, Gum Inflammation
- Keywords
- Health Belief Model, Oral health, Periodontal health, Oral microbiome, Diabetes self-management, Oral health behavior change, Glycemic control, Integrated diabetes-oral health care
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 290 participants (estimated)
- Lead sponsor
- Oman Ministry of HealthOther government
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 9 Sep 2026 (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.
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.
Detailed description
Type 2 diabetes mellitus (T2DM) is an important public health problem in Oman. Periodontal disease is common among people with diabetes, and the relationship between diabetes and periodontal disease is bidirectional. Poor glycaemic control may contribute to periodontal inflammation, while periodontal inflammation may adversely affect metabolic control. Despite this relationship, diabetes education commonly focuses on glycaemic control and general diabetes self-management, with limited structured integration of oral-health education and behavioural approaches.
This study is a multicentre, two-arm randomized controlled trial designed to evaluate the effectiveness and cost-effectiveness of an integrated diabetes-oral health educational intervention based on the Health Belief Model (HBM). The study will recruit 290 adults with T2DM (145 participants per group) from participating diabetes clinics in Oman. Participants will be allocated to either the intervention group or the control group.
Participants assigned to the intervention group will receive six structured, individual HBM-based educational sessions, approximately 30 minutes each, delivered over 12 weeks. The intervention addresses diabetes and oral-health risk awareness; the severity and consequences of periodontal disease in people with T2DM; benefits of glycaemic control and oral hygiene; barriers to oral-health self-care and practical solutions; toothbrushing, interdental cleaning, and self-monitoring skills; and maintenance planning and relapse prevention. Sessions will include structured educational material, individualized advice, and goal-setting. Participants in the control group will continue to receive standard diabetes care and education.
Data will be collected at baseline and at 3, 6, and 12 months, as appropriate for each outcome. The primary outcome is change in HbA1c from baseline to 12 months. Secondary outcomes include periodontal clinical indicators, diabetes and oral-health self-management behaviours, HBM constructs, oral health-related and general health-related quality of life, psychological well-being, diabetes distress, healthcare utilization, and direct medical costs. An economic evaluation will assess the cost-effectiveness of the intervention.
As an exploratory component, participants will undergo periodontal assessment to estimate the prevalence of previously undiagnosed periodontal disease and examine its association with glycaemic control. The study will also explore associations between changes in periodontal status and oral microbiome profiles.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two-arm, parallel-group randomized controlled trial comparing a structured Health Belief Model-based integrated diabetes-oral health educational intervention with standard diabetes care and education.
| Arm | Type | Receives |
|---|---|---|
| Health Belief Model-Based Educational Intervention | Experimental | Behavioral: Health Belief Model-Based Integrated Diabetes-Oral Health Educational InterventionParticipants allocated to this arm will receive an individualized Health Belief Model-based integrated diabetes-oral health educational programme in addition to routine diabetes care. The intervention consists of six individual face-to-face educational sessions delivered over 12 weeks, with each session lasting approximately 30 minutes. The programme addresses diabetes and oral health risk awareness, periodontal disease, benefits of glycaemic control and oral hygiene, barriers to oral health self-care, practical self-care skills, goal-setting, and maintenance planning. |
| Standard Diabetes Education and Routine Care | Active comparator | Behavioral: Standard Diabetes Education and Routine CareParticipants allocated to this arm will continue to receive standard diabetes education and routine clinical care. This includes routine advice on diet, medication adherence, physical activity, and blood glucose monitoring. Participants in this arm will not receive the structured Health Belief Model-based integrated diabetes-oral health educational intervention. |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
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 |
|---|---|---|
| Health Belief Model-Based Integrated Diabetes-Oral Health Educational InterventionParticipants will receive an individualized Health Belief Model-based integrated diabetes-oral health educational intervention in addition to routine diabetes care. The intervention consists of six individual face-to-face educational sessions delivered over 12 weeks, with each session lasting approximately 30 minutes. The sessions address diabetes and oral health risk awareness, severity and consequences of periodontal disease, benefits of glycaemic control and oral hygiene, barriers to oral health self-care and practical solutions, brushing and interdental cleaning and self-monitoring skills, and maintenance planning and relapse prevention. Each session includes structured educational material, individualized advice, and simple goal-setting. | Behavioural | Health Belief Model-Based Educational Intervention |
| Standard Diabetes Education and Routine CareParticipants will receive standard diabetes education and routine clinical care provided by existing diabetes services. Routine education includes advice on diet, medication adherence, physical activity, and blood glucose monitoring. Participants will not receive the structured Health Belief Model-based integrated diabetes-oral health educational intervention. | Behavioural | Standard Diabetes Education and Routine Care |
Primary outcome
Change in Glycated Hemoglobin (HbA1c) From Baseline to 12 Months
Time frame: Baseline to 12 months
Change in HbA1c (%) from baseline to 12 months will be used to assess the effect of the intervention on glycaemic control. HbA1c will be measured using blood samples processed in a certified hospital laboratory. The between-group difference in change over time will be evaluated.
5 secondary outcomes
Change in Probing Pocket Depth (PPD)
Time frame: Baseline, 3 months, 6 months, and 12 months
Change in Diabetes Self-Management Behaviors
Time frame: Baseline, 3 months, 6 months, and 12 months
Healthcare Utilization
Time frame: From baseline through 12 months
Change in Oral Health-Related Quality of Life Assessed Using the Oral Health Impact Profile-14 (OHIP-14)
Time frame: Baseline, 3 months, 6 months, and 12 months
Direct Medical Costs
Time frame: Baseline through 12 months
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 9 Sep 2026.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Health Belief Model-Based Integrated Diabetes-Oral Health Educational Intervention and Standard Diabetes Education and Routine Care in people with Type 2 Diabetes Mellitus and Periodontitis, run by Oman Ministry of Health.
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 5 inclusion and 7 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: opening soon, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Dr Fatma Sultan Al Maskari, Master, and 1st year Phd (95764646, s156958@student.squ.edu.om), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Glycated Hemoglobin (HbA1c) From Baseline to 12 Months (time frame: Baseline to 12 months). 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 9 Sep 2026.