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IRCT20191127045518N2 IRCT 2021-09-13 Shiraz University of Medical Sciences Effect of Nano hydroxyapatite_containing tooth paste on the health of the enamel during orthodontic treatment. The effect of Nano hydroxyapatite_containing tooth paste on enamel demineralization during the first six months of fixed orthodontic treatment- A triple-blind randomized clinical trial 2021-09-23 anticipated 36 Complete https://irct.ir/trial/58519 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. The patients will be equally divided into two groups, namely, the TP1 and TP2 group. The distribution of the group to be first assigned will be recorded on sequentially numbered cards and placed in opaque and sealed envelopes. Each participant randomly picks one envelope corresponding to either the TP1 or TP2 group. Once the participant is eligible for the procedure and all initial evaluations are completed, the allocation assignment will be revealed by opening the envelope immediately after implementation, 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 toothpastes given to the patients will be subjected to surface treatment with an abrasive cloth to remove all information regarding its contents. That way, the patients and the clinician responsible for the treatment will be blinded to the treatment that they receive. The person who uses DIAGNOdent to measure the enamel demineralization is also unaware of how individuals are assigned to the groups. Furthermore, the individual analyzing the data will be unaware of the study protocol. N/A Enamel demineralization, Nano hydroxyapatite, 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 brush with Nano-hydroxyapatite toothpaste 3 times a day. 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 brush with fluoride toothpaste 3 times a day. 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 Patients with smoking habit Patients with tooth anomalies Patients with 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 brush with Nano-hydroxyapatite toothpaste 3 times a day. 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 brush with fluoride toothpaste 3 times a day. The amount of enamel demineralization is measured by the number indicated by the DIAGNOdent device. Timepoint: The enamel demineralization 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: Evaluating by DIAGNOdent device. Shiraz University of Medical Sciences Approved 2021-08-25 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)