Inflammatory markers in orthodontic treatment with clear aligners: split mouth clinical trial

INTERVENTION: A single group of 21 patients requiring orthodontic treatment will be treated with clear aligners (Invisalign®, Align Technology, San José, CA, USA). For a period of 3 weeks one second molar will be randomly selected as study item and the contralateral will be used as control item. Using a dedicated software (ClinCheck®, Align Technology, San José, CA, USA) a single movement of 0.25 mm will be set on the first clear aligner only for the selected second molar. Gingival Crevicular Fluid (GCF) samples will be collected using periopaper strips (Harco, Tustin, Calif). Samples will be collected at the mesiobuccal and mesiolingual sites of control and test teeth at baseline, at 1 hour, at 7 days, and 21 days after placement of the appliances. Teeth will be isolated with cotton rolls, cleaned of plaque deposits, and dried gently with air before paper strips will be applied 1 mm subgingivally for 30 seconds. The volume of the sample on the paper strips will be measured using a calibrated Periotron 8000 (Harco). The readings from the Periotron will be converted to an actual volume (microliters) by reference to the standard curve calibrated with human serum. CONDITION: Malocclusion ; Oral Health ; Malocclusion, unspecified PRIMARY OUTCOME: Cytokine concentration (interleukin 1‐beta, TGF‐beta, RANKL, OPG and OPN), determined from GCF samples using titration and centrifugation at baseline, 1 hour, 7 days and 21 days SECONDARY OUTCOME: No secondary outcome measures INCLUSION CRITERIA: 1. Age >18 years 2. Absence of systemic diseases influencing bone metabolism and/or healing process 3. Good oral hygiene (FMPS e FMBS <20%) 4. Dentoskeletal Class I malocclusion (Witts appraisal) 5. Mild crowding (mean crowding 6 mm)