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IRCT20240303061155N5 IRCT 2026-04-25 Zanjan University of Medical Sciences Assessing the Effect of a Customized Method on Improving Oral Health in Patients with Multiple Sclerosis Design and Evaluation of the Efficacy of Customized Oral Health Intervention in Individuals with Multiple Sclerosis (MS) : A Randomized Controlled Trial 2026-05-10 anticipated 58 Complete https://irct.ir/trial/89570 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: In this study, participants will be randomly selected from a list of patients with multiple sclerosis using a lottery method. They will then be randomly allocated into intervention and control groups using sealed envelopes. Equal numbers of envelopes will be prepared for each group, labeled with specific colors (green for intervention and red for control). For each participant, one envelope will be randomly opened, and group assignment will be determined based on the color inside the envelope, Blinding description: This study will be conducted as a double-blind trial. Participants will be unaware of the type of intervention they receive. Outcome assessors will also be blinded to group allocation. To maintain blinding, group assignment will be performed by an independent individual, and group codes will remain concealed until data analysis is completed. N/A Design and Evaluation of the Efficacy of Customized Oral Health Intervention in Individuals with Multiple Sclerosis : A Randomized Controlled Trial. Intervention 1: Intervention group: patients with multiple sclerosis will receive a customized toothbrush with a handle specifically designed according to their hand anatomy using a molding technique. A strap will be added to improve grip and prevent dropping. In addition, individualized oral health education will be provided based on each patient’s motor ability; the Modified Bass technique will be taught to those with adequate motor function, while the Horizontal technique will be used for patients with significant motor limitations. Intervention 2: Control group: Participants in the control group will receive only individualized oral health education similar to the intervention group, adjusted to their motor abilities. However, they will not receive the customized toothbrush or any additional physical intervention. Yes - There is a plan to make this available What will be shared: All participant data can be shared after de-identification. When: The access period starts 6 months after the results are published To whom: The data will be available only to researchers working in academic and scientific institutions. Conditions: There are no special conditions. Where to obtain: To receive the data and documents, send an email to Dr.Maryam Fazli Or contact the research office of Zanjan School of Dentistry. Dr.Maryam Fazli's email: drfazli@zums.ac.ir Zanjan Faculty of Dentistry research office phone number: +98-24-33148215 How to obtain: Data requests are usually answered after two working weeks. Comments:
public Maryam ّFazli
Mahdavi blv. Zanjan University of Medical School-Dentistry Faculty
Zanjan Iran (Islamic Republic of) 4513956111 +98 912 043 6943 drfazli@zums.ac.ir Zanjan University of Medical Sciences scientific Maryam ّFazli
Mahdavi blv. Zanjan University of Medical School-Dentistry Faculty
Zanjan Iran (Islamic Republic of) 4513956111 +98 912 043 6943 drfazli@zums.ac.ir Zanjan University of Medical Sciences Iran (Islamic Republic of) The inclusion criteria are patients who are members of the Omid Charity Association of Zanjan, which is a non-governmental organization (NGO) in the city of Zanjan, who have been diagnosed with Multiple Sclerosis, do not have any mental disorders, and have provided written informed consent to participate in the study. no limit no limit Both Behavior Behavior Intervention group: patients with multiple sclerosis will receive a customized toothbrush with a handle specifically designed according to their hand anatomy using a molding technique. A strap will be added to improve grip and prevent dropping. In addition, individualized oral health education will be provided based on each patient’s motor ability; the Modified Bass technique will be taught to those with adequate motor function, while the Horizontal technique will be used for patients with significant motor limitations. Control group: Participants in the control group will receive only individualized oral health education similar to the intervention group, adjusted to their motor abilities. However, they will not receive the customized toothbrush or any additional physical intervention. Oral Health Knowledge. Timepoint: Measurement before the start of the intervention and 3 months after the start of the intervention. Method of measurement: Through a Valid and Reliable Questionnaire. Plaque Index (PI). Timepoint: Measurements will be performed at baseline (on the day of intervention) and three months after the intervention for all participants. Method of measurement: It will be measured using the Silness-Löe index with a periodontal probe on different tooth surfaces. Bleeding on Probing (BOP). Timepoint: This assessment will be carried out at baseline (on the day of intervention) and three months after the intervention for all participants. Method of measurement: It will be assessed using a periodontal probe by recording the presence or absence of bleeding after probing. Saliva Production. Timepoint: Measurements will be conducted at baseline (on the day of intervention) and three months after the intervention for all participants. Method of measurement: It will be measured using a sterile gauze method by calculating the weight difference before and after one minute of placement in the mouth using a precision scale. Zanjan University of Medical Sciences Zanjan University of Medical Sciences Zanjan University of Medical Sciences Approved 2025-04-08 Ethics committee of Zanjan University of Medical School Zanjan, Azadi Square, Beginning of Jomhouri Eslami Boulevard, Central Headquarters of Zanjan University of Medical Sciences zanjan Zanjan Iran (Islamic Republic of)