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Study aim
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determine the level of pain and inflammatory factors associated with Th17 (IL6, IL17a, IL17f, IL21) in gingival sulcus fluid in orthodontic treatment with niti and cuniti wires
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Design
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In this research, 24 eligible patients referring to Dentistry School of Shiraz University of Medical Sciences will be chosen purposefully and a code will be allocated to each one of them. Then, patients will randomly be divided in two groups of 12 people.
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Settings and conduct
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Due to extensive advertising that claim pain reduction in patients requiring fixed orthodontic treatment using copper alloy wires, a clinical trial study that compares these wires to other wires used in the treatment process, is necessary.This study will be supported by the Department of Organizational Research and the Ethics Committee of the Shiraz University of Medical Sciences in collaboration with the school of Dentistry and will be performed as a prospective double blind clinical trial in 2017 at the dentistry clinic of Shiraz University of Medical Sciences on patients requiring orthodontic treatment. Fixed orthodontist treatment with MBT system (0.022 * 0.028 slot) will be performed for all patients.The orthodontic wires used in this study are nickel-titanium (0.016 AO, USA) and orthodontic wires consisting of copper, nickel and titanium (0.016 Ormco, USA).). In this study, 24 patients that need orthodontic treatment (From persons referring to dental school of Shiraz University of Medical Sciences) will take orthodontic treatment by an orthodontist.Sample size is calculated by reviewing literatures and studies in the past also, determine the mean of applying orthodontic wires.Patients
will be selected by easy sampling method, then using a random block method (Each block consists of 4 samples) will be divided into two groups.The demographic information questionnaire, such as date, age, sex, occupation, and entry and exit criteria for patients will be recorded.visual analogue scale(vas) and numeric pain rating scale(nrs) will be used to determine the pain level. This study will be double-blind.The researcher who performs laboratory tests and also the patient do not know about the type of wire.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:Good general and periodontal health؛Orthodontic treatment plan must not include tooth extraction؛Age 12-25؛Crowding in the anterior mandibular segment
Exclusion criteria:Chronic NSAID intake؛Presence of block outed tooth that does not allow the bracket to be placed in the initial bonding session؛Pregnancy؛Antibiotic therapy in the past 6 months؛Any previous orthodontic treatment؛Radiographic evidence of periodontal bone loss
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Intervention groups
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First intervention group: Twelve patients will be nited for 4 weeks using orthodontic wires.
Second intervention group: 12 patients will use Cuniti wires for 4 weeks.
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Main outcome variables
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First out: The degree of pain in patients will be evaluated in each of the groups.
Secondary outcome: To investigate the inflammatory factors associated with TH17, the gingival fluid is collected around the inoculum teeth.