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IRCT20191127045518N1 IRCT 2020-09-16 Shiraz University of Medical Sciences Effect of Nano hydroxyapatite containing tooth paste on tooth discoloration during orthodontic treatment The effect of Nano hydroxyapatite containing tooth paste on tooth discoloration during the first six months of fixed orthodontic treatment - A triple-blind randomized clinical trial 2020-08-31 anticipated 36 Complete https://irct.ir/trial/49476 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Randomization will be carried out using a computer-generated random number sequence to produce random samples. Each consecutive patient labeled by random number go through block randomization with a block length 18, Blinding description: The trial will be triple-blinded. Both the participants and clinician will be masked to group allocation and they will not be aware of the type of toothpaste. The laboratory technician taking the photographs will be masked to intervention. Furthermore, the individual analyzing the data will be unaware of the study protocol. N/A Tooth discoloration, Nanohydroxyapatite, Fixed Orthodontic treatment. Intervention 1: Intervention group: The teeth will be etched at the bracket base area with 37% phosphoric acid for 15 seconds, rinsed, and dried. Transbond XT Adhesive Primer and Transbond XT Adhesive Resin will be used for bonding metal brackets. Bonding procedures will be performed according to the manufacturer’s instructions. Stainless steel brackets will be placed and firmly pressed onto the enamel surfaces and excess adhesive will be removed from the bracket base periphery. If a slight bit of excess adhesive is present after setting (especially along the gingival margin), it will be removed with burs.patients in the experimental group will be brush at least 3 times a day with Nano hydroxyapatite toothpaste. Intervention 2: Control group: The teeth will be etched at the bracket base area with 37% phosphoric acid for 15 seconds, rinsed, and dried. Transbond XT Adhesive Primer and Transbond XT Adhesive Resin will be used for bonding metal brackets. Bonding procedures will be performed according to the manufacturer’s instructions. Stainless steel brackets will be placed and firmly pressed onto the enamel surfaces and excess adhesive will be removed from the bracket base periphery. If a slight bit of excess adhesive is present after setting (especially along the gingival margin), it will be removed with burs. patients in the control group will be brush at least 3 times a day with fluoride toothpaste. Yes - There is a plan to make this available What will be shared: All patient data can be tracked through the journal site When: The data will be provided to the journal and the exact time of availability of the information will be announced by the journal. To whom: Eligibility for access to information is determined by the relevant journal rules. Conditions: Eligibility for access to information is determined by the relevant journal rules. Where to obtain: All patient data can be tracked through the journal site. Therefore, by searching for articles on reputable sites, it will be possible to follow and access information How to obtain: All patient data can be tracked through the journal site. Therefore, by searching for articles on reputable sites, it will be possible to follow and access information Comments:
public Ahmadreza Sardarian
Shiraz Dental School, Qasrdasht, Shiraz,
Shiraz Iran (Islamic Republic of) 7195615878 +98 917 718 8859 sardarian@sums.ac.ir Shiraz University of Medical Sciences scientific Ahmadreza Sardarian
Shiraz Dental School, Qasrdasht, Shiraz
Shiraz Iran (Islamic Republic of) 7195615878 +98 917 718 8859 sardarian@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) need for comprehensive orthodontic treatment by fixed appliances at least in the upper arch permanent dentition no plaque accumulation or gingival inflammation before bracket bonding good general health no limit no limit Both smoking habit tooth anomalies active dental caries Treatment - Other Treatment - Other Intervention group: The teeth will be etched at the bracket base area with 37% phosphoric acid for 15 seconds, rinsed, and dried. Transbond XT Adhesive Primer and Transbond XT Adhesive Resin will be used for bonding metal brackets. Bonding procedures will be performed according to the manufacturer’s instructions. Stainless steel brackets will be placed and firmly pressed onto the enamel surfaces and excess adhesive will be removed from the bracket base periphery. If a slight bit of excess adhesive is present after setting (especially along the gingival margin), it will be removed with burs.patients in the experimental group will be brush at least 3 times a day with Nano hydroxyapatite toothpaste. Control group: The teeth will be etched at the bracket base area with 37% phosphoric acid for 15 seconds, rinsed, and dried. Transbond XT Adhesive Primer and Transbond XT Adhesive Resin will be used for bonding metal brackets. Bonding procedures will be performed according to the manufacturer’s instructions. Stainless steel brackets will be placed and firmly pressed onto the enamel surfaces and excess adhesive will be removed from the bracket base periphery. If a slight bit of excess adhesive is present after setting (especially along the gingival margin), it will be removed with burs. patients in the control group will be brush at least 3 times a day with fluoride toothpaste. Percentage of patients who have a color measurement criterion (ΔΕ) of more than one unit. Timepoint: The tooth color will be recorded 3 times during the first 6 months of fixed orthodontic treatment. At the start of the study and 3, 6 months during the treatment. Method of measurement: Digital photographic assessment. Shiraz University of Medical Sciences Approved 2020-04-29 Ethics committee of Shiraz University of Medical Sciences Orthodontics Research Center, Department of Orthodontics, Shiraz University of Medical Science, Shiraz, Iran. Shiraz Fars Iran (Islamic Republic of)