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IRCT20241014063362N2 IRCT 2025-11-14 Yazd University of Medical Sciences Comparison of the Effectiveness of Interdental Aids in Reducing Plaque in Patient with Gingivitis Comparison of the Effectiveness of Interdental Aids in Reducing Plaque in Patient with Gingivitis 2025-10-23 anticipated 54 Recruiting https://irct.ir/trial/86574 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The randomization is performed using Simple Random Allocation. First, a sequence of random numbers from 1 to 54 is generated using the PASS 2021 software. The software output is a follow-up Excel file containing the numbers from 1 to 54 and a unique code for the study units. The patients who meet the criteria from numbers 1 to 54 are considered and allocated to one of the intervention groups (A, B, or C), Blinding description: To ensure Blinding of the referrals (patients), we use the help of a third person who is unaware of the interventions, and the table is provided to them. When a study unit (patient) is referred and meets the criteria, the intervention group (A, B, or C) is asked from the third person by phone based on the patient's number, and the patient is assigned to one of the specified groups. N/A gingivitis. Intervention 1: Intervention group: Using a soft toothbrush (Rejoy, Iran) and toothpaste (Pooneh, Iran) along with dental floss (Oxygen, Iran) - brushing twice a day and flossing once a day. Intervention 2: Intervention group: Use a soft toothbrush (Rejoy, Iran) and toothpaste (Pooneh, Iran) with a wooden toothpick (Bamboo, Iran) - brushing teeth twice a day and using a wooden toothpick once a day. Intervention 3: Intervention group: Using a soft toothbrush (Rejoy, Iran) and toothpaste (Pooneh, Iran) with a soft pick (Oral B, America) - brushing twice a day and using a soft pick once a day. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information.
public Roghaye Eslami Nosrat Abadi
10th Alley, Imam Jafar Sadegh st., vakil st.,Jomhouri Blvd.
Yazd Iran (Islamic Republic of) 8917931753 +98 35 3526 2688 reslami2002@gmail.com Yazd University of Medical Sciences scientific Roghaye Eslami Nosrat Abadi
10th Alley, Imam Jafar Sadegh st., vakil st.,Jomhouri Blvd.
Yazd Iran (Islamic Republic of) 8917931753 +98 35 3526 2688 reslami2002@gmail.com Yazd University of Medical Sciences Iran (Islamic Republic of) Patient's age is between 18-50 years Patient has generalized gingivitis No history of periodontal treatment in last 6 months No history of antibiotic consumption in the last 3 months Patient is physically healthy in terms of systemic health (patient is free of any physical-motor restrictions that limit hygienic practices) Absence of inflammatory conditions in the oral mucosa such as Aphthous Ulcers and Lichen Planus No use of drugs affecting the periodontium, such as anticonvulsants, calcium channel blockers, and immunosuppressants. No history of smoking Patient's crowding is less than 4 mm 18 years 50 years Both Failure of the patient to attend the follow-up session Identification of a systemic disease that affects periodontal conditions during the study K05 Gingivitis and periodontal diseases Prevention Prevention Prevention Intervention group: Using a soft toothbrush (Rejoy, Iran) and toothpaste (Pooneh, Iran) along with dental floss (Oxygen, Iran) - brushing twice a day and flossing once a day Intervention group: Use a soft toothbrush (Rejoy, Iran) and toothpaste (Pooneh, Iran) with a wooden toothpick (Bamboo, Iran) - brushing teeth twice a day and using a wooden toothpick once a day Intervention group: Using a soft toothbrush (Rejoy, Iran) and toothpaste (Pooneh, Iran) with a soft pick (Oral B, America) - brushing twice a day and using a soft pick once a day Full mouth plaque index. Timepoint: At the beginning of the study (before the intervention) and 4 weeks after use. Method of measurement: Percentage of plaque-bearing surfaces on existing teeth. Bleeding index. Timepoint: At the beginning of the study (before the intervention) and 4 weeks after use. Method of measurement: Percentage of surfaces with bleeding in existing teeth during probing. Probing depth. Timepoint: At the beginning of the study (before the intervention) and 4 weeks after use. Method of measurement: Distance from gingival margin to sulcus depth. Ease of use (Patient satisfaction). Timepoint: 4 weeks after use. Method of measurement: Visual analog scale ( VAS ). Yazd University of Medical Sciences Approved 2025-08-03 Ethics Committee of Shahid Sadoughi University of Medical Sciences, Yazd Central Organization of Shahid Sadougi University of Medical Sciences and Healthcare Services, Shahid Dr. Bahner Square yazd Yazd Iran (Islamic Republic of)