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IRCT20200618047823N1 IRCT 2020-07-06 Tehran University of Medical Sciences Evaluation of efficacy of an Iranian-made toothbrush in orthodontic patients Evaluation of clinical efficacy of an Iranian-made toothbrush in fixed orthodontic patients (Randomized clinical trial) 2020-07-09 anticipated 40 Complete https://irct.ir/trial/49104 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Randomization is done by Balanced block randomization. To randomize the samples, they are numbered in order of entry into the study, Randomization is done using 4 random blocks.Due to the fact that there are 2 different modes of 2 types of intervention, in each block 2 samples are assigned to each of the following states: 1. First Oral B then Confident 2. First Confident then Oral B The placement of samples inside the blocks will be by Random allocation method, in such a way that there are 2 samples from each group in the block. Randomization is done using Excel software and This process is designed by the project methodological consultant who is not involved in the executive operation of the study, Blinding description: Participant: The brand name of the toothbrush is covered. Care provider: The toothbrushes are distributed by another person and the person who measures indexes does not know how the participants are allocated in groups. Outcome assessor: The toothbrushes are distributed by another person and the person who gives patients information about oral hygiene and the method of brushing does not know how the participants are allocated in groups. N/A Evaluation of Plaque index (Silness & Loe), Gingival index (Silness & Loe) and Ortho-plaque index in fixed orthodontic patients. Intervention 1: Intervention group: Participants use an Iranian toothbrush (Confident brand, with national standard mark, ISO 9001 certification and ISO 13485 certification) for one month, twice a day, 4 minutes each time, Modified bass method. All of them are taught by a clinician using a face-to-face dental model and instruction videos to brush the Modified bass method. Patients in both groups are advised to use the same interdental toothbrush, orthodontic floss, toothpaste and mouthwash. Also do not change them during the study period. At the beginning of the study and after one month, the Plaque index, Gingival index and Ortho-plaque index are measured using disclosing tablets (Made in USA). The clinical efficiency of the toothbrush is evaluated by comparing these indexes. Intervention 2: Control group: Participants use Oral B toothbrush (Made in Ireland ) for one month, twice a day, 4 minutes each time, Modified bass method. All of them are taught by a clinician using a face-to-face dental model and instruction videos to brush the Modified bass method. Patients in both groups are advised to use the same interdental toothbrush, orthodontic floss, toothpaste and mouthwash. Also do not change them during the study period. At the beginning of the study and after one month, the Plaque index, Gingival index and Ortho-plaque index are measured using disclosing tablets (Made in USA). The clinical efficiency of the toothbrush is evaluated by comparing these indexes. 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 No more information
public Atefeh Saffar Shahroudi
N kargar st.,Tehran University of Medical Sciences Faculty of Dentistry
Tehran Iran (Islamic Republic of) 300088351176 +98 21 4279 4000 Atefe.saffar@yahoo.com Tehran University of Medical Sciences scientific Behrad Tanbakuchi
N kargar st.,Tehran University of Medical Sciences Faculty of Dentistry
Tehran Iran (Islamic Republic of) 300088351176 +98 21 4279 4000 behrad.tanbakuchi@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) Patients are 13-35 years old. Patients are at the end of the first phase of treatment. Patients have a fixed orthodontic appliance for at least one month. Patients are physically and mentally healthy in order to observe oral hygiene. Patient's consent to participate in the study and use of prescribed toothbrushes 13 years 35 years Both Systemic disease History of antibiotic use over the past two months The presence of lingual arch in the lower jaw and transpalatal arch or Nance in the upper jaw and any auxillary appliance such as headgear, intrusion arch and ... Prevention Prevention Intervention group: Participants use an Iranian toothbrush (Confident brand, with national standard mark, ISO 9001 certification and ISO 13485 certification) for one month, twice a day, 4 minutes each time, Modified bass method. All of them are taught by a clinician using a face-to-face dental model and instruction videos to brush the Modified bass method. Patients in both groups are advised to use the same interdental toothbrush, orthodontic floss, toothpaste and mouthwash. Also do not change them during the study period. At the beginning of the study and after one month, the Plaque index, Gingival index and Ortho-plaque index are measured using disclosing tablets (Made in USA). The clinical efficiency of the toothbrush is evaluated by comparing these indexes. Control group: Participants use Oral B toothbrush (Made in Ireland ) for one month, twice a day, 4 minutes each time, Modified bass method. All of them are taught by a clinician using a face-to-face dental model and instruction videos to brush the Modified bass method. Patients in both groups are advised to use the same interdental toothbrush, orthodontic floss, toothpaste and mouthwash. Also do not change them during the study period. At the beginning of the study and after one month, the Plaque index, Gingival index and Ortho-plaque index are measured using disclosing tablets (Made in USA). The clinical efficiency of the toothbrush is evaluated by comparing these indexes. Plaque index (Silness & Loe). Timepoint: Measurement of Plaque index at the beginning of the study (before the start of the intervention) and 30, 37 and 67 days after the start of the study. Method of measurement: Disclosing tablets. Gingival index (Silness & Loe). Timepoint: Measurement of Gingival index at the beginning of the study (before the start of the intervention) and 30, 37 and 67 days after the start of the study. Method of measurement: Williams periodontal probe. Ortho-plaque index. Timepoint: Measurement of Ortho-plaque index at the beginning of the study (before the start of the intervention) and 30, 37 and 67 days after the start of the study. Method of measurement: Disclosing tablets. Tehran University of Medical Sciences Approved 2020-06-14 Ethics committee of Dentistry school of Tehran University of Medical Science N Kargar st.,Tehran University of Medical Sciences Faculty of Dentistry Tehran Tehran Iran (Islamic Republic of)