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IRCT20150101020523N4 IRCT 2019-12-19 Hamedan University of Medical Sciences Evaluation of the staining effect of Orthokin mouthwash Evaluation of the effect of Orthokin mouthwash in comparison with chlorhexidine mouthwash on tooth staining in patient with fix orthodontic appliance: A randomized clinical trial 2020-01-21 anticipated 70 Complete https://irct.ir/trial/43991 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization was done with individual unit of randomization. Patient allocation and allocation concealment was conducted with numbers in sealed and opaque pockets, Blinding description: Mouthwashes are given in identical bottles and patients are not aware which bottle contains which solution. In addition, the person who assess the staining status and statistician are unaware of the consumed mouthwash. 3 Staining status of teeth. Intervention 1: Intervention group: Mouth rinse with 15 milliliter of Orthokin mouthwash (Kin laboratory, Spain) containing diluted chlorhexidine, sodium floride and zinc acetate, 1 minute, 3 times per day for 4 weeks. Intervention 2: Control group: Mouth rinse with 15 milliliter of 2% chlorhexidine mouthwash (Najoo, Iran) , 1 minute, 3 times per day for 4 weeks. Yes - There is a plan to make this available What will be shared: Data regarding primary outcome measure will be shared. When: Data will be shared 6 months after data publication To whom: Data will be available for all people. Conditions: Data will be available for future research project and for data accumulation for systematic reviews. Where to obtain: Applicant can receive data by sending an email to se.soheilifar@gmail.com. How to obtain: Applicants can send an email and tell their reason for receiving data.Data will be send within 2 weeks. Comments:
public Hananeh Khodadadi
Dental Faculty, Hamadan University of Medical Sciences, Shahid Fahmideh Street
Hamadan Iran (Islamic Republic of) 654178-38741 +98 81 3838 1085 hannaneh_khodadadi@yahoo.com Hamedan University of Medical Sciences scientific Sepideh Soheilifar
Orthodontic department, Dental Faculty, Hamadan University of Medical Sciences, Shahid Fahmideh Street
Hamadan Iran (Islamic Republic of) 654178-38741 +98 81 3838 1085 se.soheilifar@gmail.com Hamedan University of Medical Sciences Iran (Islamic Republic of) Systematically healthy people History of acceptable compliance with treatment Healthy periodontium or mild gingivitis with pocket depth less than 3 milimeters and with no loss of attachment 14 years 30 years Both Special drug consumption (hypertension, antihistamine, chemotherapy drugs) Presence of active dental caries Presence of staining on labial surface of the teeth Consumption of tea, coffee or chocolate milk more than three times per day Smoking Treatment - Drugs Treatment - Drugs Intervention group: Mouth rinse with 15 milliliter of Orthokin mouthwash (Kin laboratory, Spain) containing diluted chlorhexidine, sodium floride and zinc acetate, 1 minute, 3 times per day for 4 weeks Control group: Mouth rinse with 15 milliliter of 2% chlorhexidine mouthwash (Najoo, Iran) , 1 minute, 3 times per day for 4 weeks Staining status according to Extrinsic Enamel Stain Index. Timepoint: At baseline (before intervention) and 4 weeks later. Method of measurement: Extrinsic Enamel Stain Index by Loben method. Gingival health status. Timepoint: At baseline and 4 weeks later. Method of measurement: Gingival index. Hamedan University of Medical Sciences Approved 2019-10-26 Ethnic committee of Hamadan University of Medical Sciences Orthodontic department, Dental Faculty, Shahid Fahmideh Street Hamadan Hamadan Iran (Islamic Republic of)