Assessment of oral health status and effectiveness of an online oral health promotion program multiple sclerosis patients

The aim of this study is to evaluate the effectiveness of a social cognitive theory–based digital oral health education program on knowledge, attitudes, and oral health–related behaviors among patients with multiple sclerosis in Zanjan

randomized controlled trial with two parallel groups, enrolling 100 MS patients equally randomized by age and sex using Excel’s RAND function; study is not double-blinded.

The study will be conducted at the Omid Rehabilitation Center in Zanjan. Participants will be randomly assigned to two groups: intervention (receiving WhatsApp education) and control (no education), stratified by age and sex. Outcome assessments will be performed by blinded evaluators who are unaware of group assignments to prevent bias.

Inclusion Criteria: Confirmed diagnosis of MS (based on medical records) At least 6 months since diagnosis Active medical file at Omid MS Center in Zanjan No dementia, psychiatric disorders, or severe physical disability Basic literacy (reading and writing skills) Not completely edentulous Exclusion Criteria: Severe physical disability preventing clinic attendance Systemic diseases affecting oral health No access to a smartphone Unwillingness to participate in the study

Intervention Group: a six-week oral health education program via WhatsApp, covering key oral hygiene topics with short quizzes to reinforce learning. Control Group: receive usual care at the center without additional education during the study. After the study, educational materials will be provided to them.

Knowledge, attitudes, and practices (KAP) of patients with multiple sclerosis toward oral health; Plaque Index (PI); Periodontal Disease Index (PDI)

To perform randomization, participants were first stratified based on gender (female/male) and age group (18–39 years / 40–60 years) into four distinct strata. Within each stratum, individuals were assigned sequential numerical codes (1, 2, 3, etc.). A random selection of codes was then performed within each stratum using either a table of random numbers or a computer-generated randomization tool. This stratified randomization method helped ensure a balanced distribution of key demographic variables, such as age and gender, across the three intervention groups, thereby enhancing the internal validity of the study.

Due to the behavioral and educational nature of the interventions, participant blinding is not feasible, as they will be aware of the type of intervention they receive. However, to minimize bias in outcome assessment, blinding of the outcome assessor and blinding of the clinical supervisor will be implemented. The outcome assessor, responsible for collecting quantitative and qualitative data such as the Plaque Index and Gingival Index, will remain unaware of participants' group allocation to ensure objective and unbiased evaluations. Similarly, the clinical supervisor who monitors participants’ overall health status and manages follow-up will also be blinded to group assignments, reducing potential bias in adverse event reporting and clinical follow-up. Blinding these two roles helps reduce assessment and reporting bias, thereby enhancing the internal validity of the study.

Title of the Documents or Data Files: Individual Participant Data from the Clinical Trial on Oral Health Education in Patients with Multiple Sclerosis Details: The collected data include demographic information, Knowledge-Attitude-Practice (KAP) scores regarding oral health, and clinical indicators such as plaque index and periodontal disease index. After de-identification and proper data encryption, partial sharing of the dataset (e.g., primary outcome results) will be possible for research purposes in compliance with ethical standards.

Timeframe for Data/Document Availability: Data will be available starting 6 months after publication of the final results and will remain accessible to qualified researchers for a period of 3 years.

Authorized Individuals for Access: The data will only be available to academic researchers and individuals affiliated with recognized research institutions. Requests from non-commercial health-related organizations may also be considered.

De-identified data can only be used for research purposes and statistical analyses related to oral health and the study topic. Commercial or promotional use is not permitted. Applicants must submit a formal request outlining the research aim, type of intended analyses, and approval from an ethics committee or relevant institution. Requests will be reviewed by the research team, and upon approval, limited access will be granted under a data confidentiality agreement.

Applicants wishing to access the data or documents can submit their requests via email to the principal investigator, Dr. Seyed Kian Haji Seyed Javadi, at kian.javadi.dentist@gmail.com. They may also contact by phone at +98 912 641 7256 for further information. For postal correspondence, the research center's address is as follows: Dental Sciences Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Shahrak Ghods (West), between Flamark Jonubi and Zarafshan, Simaye Iran Street, Block A, 13th Floo

Applicants requesting data or documents must first submit a formal request via email to the principal investigator, including the purpose of use, the type of data or documents needed, and a commitment to comply with the terms of use. Upon receipt, the research team will review the request and, if complete and in accordance with privacy and ethical policies, approve it. Then, a confidentiality agreement outlining usage restrictions will be signed by the applicant. After signing this agreement, the requested data or documents will be provided in an appropriate format, typically within 2 to 4 weeks. If additional information or documents are required, the process may take longer, and the applicant will be informed accordingly.