Integrated Diabetes and Oral Health Care in Oman

Authors
Category Primary study
Registry of TrialsClinicalTrials.gov
Year 2026
Type 2 diabetes mellitus (T2DM) is an important public health problem in Oman.Periodontal disease is common among people with diabetes, and the relationship betweendiabetes and periodontal disease is bidirectional. Poor glycaemic control may contributeto periodontal inflammation, while periodontal inflammation may adversely affectmetabolic control. Despite this relationship, diabetes education commonly focuses onglycaemic control and general diabetes self‐management, with limited structuredintegration of oral‐health education and behavioural approaches.This study is a multicentre, two‐arm randomized controlled trial designed to evaluate theeffectiveness and cost‐effectiveness of an integrated diabetes‐oral health educationalintervention based on the Health Belief Model (HBM). The study will recruit 290 adultswith 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, individualHBM‐based educational sessions, approximately 30 minutes each, delivered over 12 weeks.The intervention addresses diabetes and oral‐health risk awareness; the severity andconsequences of periodontal disease in people with T2DM; benefits of glycaemic controland oral hygiene; barriers to oral‐health self‐care and practical solutions;toothbrushing, interdental cleaning, and self‐monitoring skills; and maintenance planningand relapse prevention. Sessions will include structured educational material,individualized advice, and goal‐setting. Participants in the control group will continueto receive standard diabetes care and education.Data will be collected at baseline and at 3, 6, and 12 months, as appropriate for eachoutcome. The primary outcome is change in HbA1c from baseline to 12 months. Secondaryoutcomes include periodontal clinical indicators, diabetes and oral‐healthself‐management behaviours, HBM constructs, oral health‐related and generalhealth‐related quality of life, psychological well‐being, diabetes distress, healthcareutilization, and direct medical costs. An economic evaluation will assess thecost‐effectiveness of the intervention.As an exploratory component, participants will undergo periodontal assessment to estimatethe prevalence of previously undiagnosed periodontal disease and examine its associationwith glycaemic control. The study will also explore associations between changes inperiodontal status and oral microbiome profiles.
Epistemonikos ID: d1d713d4d6094946e54289b72bc87abe15e9333e
First added on: Sep 10, 2026