Integrated Diabetes and Oral Health Care in Oman

NCT07809477 | Not Yet Recruiting

• 1 other identifier: MoH/CSR/26/32411
• Study Type: interventional
• Target: 290
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Periodontitis; T2DM; Periodontal Disease; Type 2 Diabetes; Gum Inflammation; Non Insulin Dependent Diabetes; NIDDM; Type 2 Diabetes Mellitus

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline to 12 months

Secondary Outcomes (5)

• Change in Probing Pocket Depth (PPD)

  Baseline, 3 months, 6 months, and 12 months

• Change in Diabetes Self-Management Behaviors

  Baseline, 3 months, 6 months, and 12 months

• Healthcare Utilization

  From baseline through 12 months

• Change in Oral Health-Related Quality of Life Assessed Using the Oral Health Impact Profile-14 (OHIP-14)

  Baseline, 3 months, 6 months, and 12 months

• Direct Medical Costs

  Baseline through 12 months

Study Arms (2)

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.

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.

Behavioral: Standard Diabetes Education and Routine Care

Interventions

Standard Diabetes Education and Routine Care BEHAVIORAL

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.

Standard Diabetes Education and Routine Care

Health Belief Model-Based Integrated Diabetes-Oral Health Educational Intervention BEHAVIORAL

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.

Health Belief Model-Based Educational Intervention

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oman Ministry of Health: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Periodontitis; Periodontal Diseases; Gingivitis

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Dr Fatma Sultan Al Maskari, Master, and 1st year Phd

CONTACT

95764646; s156958@student.squ.edu.om

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 16, 2026
• First Posted: September 9, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: September 9, 2026

Record last verified: 2026-08