]>
IRCT20190827044632N1 IRCT 2019-10-05 Kerman University of Medical Sciences Effect of flouride mouthwash and tooth-mousse paste on fixed orthodontic appliances Effect of flouride mouthwash and tooth-mousse paste usage on ion release and PH of soliva in patients undergoing fixed orthodontic treatment 2019-09-23 anticipated 36 Complete https://irct.ir/trial/41802 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Each patient is assigned a number based on a random number table obtained by using a computer software (NCSS, Kaysville, UT, USA). Details of different groups are stored on cards and in sealed envelopes that are similar in appearance and have their own group contents. These envelops are numbered by an independent individual and assigned to patients based on the number of them, Blinding description: Each patient receives a packet containing the health contents of their group. Once the study volunteer has been evaluated by the lead researcher and his/her compliance with the inclusion criteria has been confirmed, the envelope dedicated to the patient will be opened by a senior resident in the field of orthodontics and the study process will begin. N/A Ion release and PH of soliva during use of different remineralizing agents in patients undergoing fixed orthodontic treatment. Intervention 1: Control group: All patients are instructed to brush their teeth twice a day for 3 minutes using 1450 ppm fluoride toothpaste. They are asked not to use any oral hygiene products or instruments, including Oral irrigators or antimicrobial mouthwashes, during the study. Intervention 2: Intervention group: Following health training similar to group 1, Patients were asked to place 5 mm of ACP-CPP cream (GC Tooth Mousse, Asia Pty. Ltd, Japan) twice a day after brushing on their tooth surfaces and they were advised to keep the paste on the surface of their teeth for at least 3 minutes before washing their mouths. Patients should not take any food or drink for 30 minutes after using CPP-ACP paste, and any other fluoride supplement is not permitted. Intervention 3: Intervention group: Patients are instructed to rinse 15 ml fluoride in their mouths for 30 seconds twice a day after brushing, and then refrain from eating, drinking and washing for 30 minutes. Yes - There is a plan to make this available What will be shared: only part of the data, such as the main outcome information, can be shared. When: 6 month after the results are published To whom: researchers working in academic institutions Conditions: For review in academic and scientific environments Where to obtain: behnoosh.hormozy@gmail.com How to obtain: As soon as posible Comments:
public Behnoush Hormozi
School of Dentistry, Kerman University of medical Sciences, Shafa Stree, Kerman, Iran
Kerman Iran (Islamic Republic of) 7618759689 +98 34 3211 9021 Behnoosh.hormozy@gmail.com Kerman University of Medical Sciences scientific Samaneh Sadeghi
School of Dentistry, Kerman University of medical Sciences, Shafa Stree, Kerman, Iran
Kerman Iran (Islamic Republic of) 7618759689 00983432119021-30 samaneh_sa82@yahoo.com Kerman University of Medical Sciences Iran (Islamic Republic of) No history of systemic disease Lack of dental Caries Absence of active periodontal disease Patients in Permanent dental stage No metal crowns, bridge or any nickel and chromium restorations in the patient's mouth The patient does not have previous orthodontic treatment 12 years 30 years Both Patient with cleft lip or palate or any type of oral syndrome Evolutionary enamel lesions Multiple dental restorations History of allergy to milk proteins Use of antibiotics during the study Oral breathing Smokers Lifestyle Prevention Prevention Control group: All patients are instructed to brush their teeth twice a day for 3 minutes using 1450 ppm fluoride toothpaste. They are asked not to use any oral hygiene products or instruments, including Oral irrigators or antimicrobial mouthwashes, during the study. Intervention group: Following health training similar to group 1, Patients were asked to place 5 mm of ACP-CPP cream (GC Tooth Mousse, Asia Pty. Ltd, Japan) twice a day after brushing on their tooth surfaces and they were advised to keep the paste on the surface of their teeth for at least 3 minutes before washing their mouths. Patients should not take any food or drink for 30 minutes after using CPP-ACP paste, and any other fluoride supplement is not permitted. Intervention group: Patients are instructed to rinse 15 ml fluoride in their mouths for 30 seconds twice a day after brushing, and then refrain from eating, drinking and washing for 30 minutes. The rate of release of nickel ion. Timepoint: Before orthodontic treatment, 1 month and 2 month after orthodontic treatment. Method of measurement: Atomic absorption spectrophotometer. The rate of release of chromium ion. Timepoint: Before orthodontic treatment, 1 month and 2 month after orthodontic treatment. Method of measurement: Atomic absorption spectrophotometer. Kerman University of Medical Sciences Approved 2019-07-29 Iran National Committee For Ethics In Biomedical Research Floor 13, Block A, Ministry of Health & Medical Education Headquarters, Between Zarafshan & South Falamak, Qods Town, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)