Effectiveness of a social cognitive theory–based oral health education programme among people with multiple sclerosis: study protocol for a three-arm randomised controlled trial

Vollständiger Abstract

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Abstract Background People with multiple sclerosis experience physical, cognitive, and medication-related challenges that can compromise oral self-care and increase their risk of oral disease. However, tailored, theory-based oral health interventions for this population remain limited. This trial aims to evaluate two social cognitive theory–based oral health education interventions, delivered via WhatsApp and face-to-face motivational interviewing, to improve oral health knowledge, attitudes, practices, and clinical outcomes among people with multiple sclerosis. Methods This single-centre, three-arm, parallel-group superiority randomised controlled trial will enrol 201 adults with multiple sclerosis aged 18–60 years at the Omid MS Rehabilitation Center in Zanjan, Iran. Participants will be allocated in a 1:1:1 ratio using stratified randomisation with concealed allocation to a 6-week WhatsApp-based oral health education programme, six weekly face-to-face motivational interviewing sessions, or usual care. The primary outcome family will comprise changes from baseline in oral health knowledge, attitude, and practice domain scores, assessed using a 26-item questionnaire that was content-validated and pilot-tested prior to baseline assessment and randomisation. The domains will be tested at the 3-month follow-up in the prespecified hierarchical order of practice, attitude, and knowledge; the immediate post-intervention assessment will provide supportive evidence. Secondary outcomes will comprise changes from baseline in mean Plaque Index and Gingival Index scores. Outcomes will be measured at baseline, immediately after the interventions and at the 3-month follow-up. Clinical examinations will be performed by an assessor blinded to group allocation. Recruitment will begin in November 2025 and continue until January 2026. Following baseline assessment and randomisation, the 6-week interventions will be delivered between February and March 2026, with the immediate post-intervention and final 3-month follow-up assessments completed by June 2026. Discussion This trial will compare two theory-informed oral health education approaches with usual care among people with multiple sclerosis. If effective, these interventions may inform accessible, scalable, and technology-assisted oral health promotion for people with multiple sclerosis and provide a basis for future studies of long-term effectiveness, cost-effectiveness, and broader application in chronic disease management. Trial registration Iranian Registry of Clinical Trials, IRCT20250414065316N1. Registered on 23 Sep 2025.