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IRCT20140215016582N5 IRCT 2021-01-24 Hamedan University of Medical Sciences The effect of bioactive glass toothpaste on improving the early stages of dental caries during fixed orthodontic treatment Effect of toothpaste containing Bioactiveglass in remineralization of white spot lesion during fixed orthodontic treatment: A randomized clinical trial 2021-01-20 anticipated 38 Complete https://irct.ir/trial/52294 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Based on the block quantification method, it is divided into control group and study group by the researcher. The method of confiscation is that four blocks are used. If there are two treatments A and B, there are six different blocks as AABB, BBAA, ABAB, BABA, ABBA and BAAB. Random numbers between zero and one are now generated and the blocks are randomly selected based on random numbers. Thus, for numbers between 0 and 0.17, the first block, for numbers between 0.18 and 0.33, and the second block, for numbers between 0.34 and, Blinding description: In this study, patients are aware of the purpose of the study, which is to control white enamel lesions, but are blind to the product to be used in the study or to the group to which they belong. All tubes are covered by a blinding label. Assessments at all appointments are performed by an independent researcher who is blind to the groups. Statistical analysis is performed by a researcher who is blind to treatments. N/A Enamel white lesions. Intervention 1: Intervention group: Receiving toothpaste containing bioactive glass. In this group, the amount of tooth mineralization is first determined using a diagnostic laser made by the German company Kavo. Patients are then given toothpaste containing the bioactive glass (sensodyne, powered by Novamin) in a white tube without specifications and patients are instructed twice a day with a certain amount of toothpaste (about the size of a pea) for Brush their teeth for two minutes in 3 months. The amount of mineralization of the tooth is measured by the diagnostic device one and three months later. Intervention 2: Control group: Patients receiving fluoride toothpaste. In this group, the amount of tooth mineralization is first determined using a diagnostic laser made by the German company Kavo. Fluoride toothpaste (sensodyne, Rapid Relief) is then given to patients in a white tube without specifications and patients are instructed to take a certain amount of toothpaste (about the size of a pea) twice a day for two minutes. Brush their teeth for 3 months. The amount of mineralization of the tooth is measured by the diagnostic device one and three months later. Yes - There is a plan to make this available What will be shared: Individual data includes demographic characteristics and original outcome information are shared When: Start the access period starts 6 months after printing the results To whom: Researchers working in academic and scientific institutes and companies producing toothpaste Conditions: Unidentifiable information will not be provided due to the type of consent given to patients and the obligation of the investigator to comply with ethical requirements. Where to obtain: Maryam Haidarpour: corresponding author, Maryamheydarpour @ gmail.com Vahid Malabashi: First author, mollabashi@umsha.ac.ir How to obtain: After result publication through electronic E Mail of corresponding author and complete introduction and mention the goal from having the documentation, within a maximum one week related file is available to the applicant Comments:
public Maryam Heydarpour
Shahid Fahmide Ave
Hamadan Iran (Islamic Republic of) 654178-38741 +98 81 3838 1059 Maryamheydarpour97@gmail.com Hamedan University of Medical Sciences scientific Maryam Heydarpour
Shahid Fahmide Ave
Hamadan Iran (Islamic Republic of) 654178-38741 +98 81 3838 1059 Maryamheydarpour97@gmail.com Hamedan University of Medical Sciences Iran (Islamic Republic of) Fixed orthodontic applique on all teeth Remain at least 3 months until the end of fixed orthodontic treatment Having at least one white enamel lesion on the buccal surface of six anterior teeth and the first premolars in the maxilla or mandible 15 years 30 years Both Active dental caries Active periodontal disease Teeth with enamel defects Teeth with internal and external discoloration such as fluorosis or tetracycline discoloration Primary teeth Facial-oral syndromes and cleft lip and palatal deformity Patients under medical treatment or patients taking any type of medication K02 Dental caries Treatment - Other Other Intervention group: Receiving toothpaste containing bioactive glass. In this group, the amount of tooth mineralization is first determined using a diagnostic laser made by the German company Kavo. Patients are then given toothpaste containing the bioactive glass (sensodyne, powered by Novamin) in a white tube without specifications and patients are instructed twice a day with a certain amount of toothpaste (about the size of a pea) for Brush their teeth for two minutes in 3 months. The amount of mineralization of the tooth is measured by the diagnostic device one and three months later Control group: Patients receiving fluoride toothpaste. In this group, the amount of tooth mineralization is first determined using a diagnostic laser made by the German company Kavo. Fluoride toothpaste (sensodyne, Rapid Relief) is then given to patients in a white tube without specifications and patients are instructed to take a certain amount of toothpaste (about the size of a pea) twice a day for two minutes. Brush their teeth for 3 months. The amount of mineralization of the tooth is measured by the diagnostic device one and three months later Change in white enamel lesions. Timepoint: At the beginning of the study and one month later and three months later. Method of measurement: Diagnodent laser device. Hamedan University of Medical Sciences Approved 2020-12-14 Ethics committee of Hamadan University of Medical Science Shahid Fahmide Ave, Hamadan Hamadan Iran (Islamic Republic of)