Anomalies of tooth position
Conditions
Interventions
This is a two-arm, parallel, randomized controlled clinical trial (1:1 allocation). Experimental group: 17 patients with mild to moderate mandibular anterior crowding will be treated with ceramic nano
however, outcome assessment will be performed by independent, blinded evaluators. Monthly follow-ups will be conducted until complete alignment, with an estimated maximum treatment duration of 12 mont
Sponsors
Faculdade de Odontologia de Bauru – Universidade de São Paulo
Faculdade de Odontologia de Bauru – Universidade de São Paulo
Eligibility
Age
13 Years to 30 Years
Inclusion criteria
Inclusion criteria: Patients aged between 13 and 30 years; presence of mild to moderate mandibular anterior crowding with a Little’s irregularity index greater than 2 mm; satisfactory posterior occlusion showing proper intercuspation of molars and premolars; complete permanent dentition with all teeth present at least up to the first molars; acceptable oral hygiene assessed by clinical examination; good general health
Exclusion criteria
Exclusion criteria: Patients with the presence of any malocclusion requiring orthodontic treatment other than anterior crowding; presence of large rotations or positional alterations of the canines; periodontal conditions that may be aggravated by labial inclination of the lower incisors; poor oral hygiene or presence of active periodontal disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected outcome 1 – Treatment effectiveness. It is expected to find greater clinical effectiveness of ceramic nanotubes in correcting mandibular anterior crowding compared with conventional metallic fixed appliances, verified through the reduction of Little’s Irregularity Index (LII) and the maintenance or improvement of occlusal variables (intercanine distance, overjet, and overbite). Measurements will be obtained from intraoral digital scans (Trios 3, 3Shape, Denmark) and analyzed using the 3D Slicer software (version 5.7.0) comparing T1 and T2 models. | — |
Secondary
| Measure | Time frame |
|---|---|
| Expected outcome 2 – Survival rate of orthodontic accessories (Secondary outcome). It is expected to observe a higher survival rate of nanotube orthodontic accessories compared with conventional brackets, assessed by recording adhesive failures, wire fractures, and accessory fractures during treatment (T1–T2). Data will be recorded in Excel sheets, and the overall survival rate will be expressed as a percentage, identifying the main causes of failure.;Expected outcome 3 – Periodontal condition. It is expected to maintain or improve periodontal conditions in patients treated with ceramic nanotubes compared with conventional brackets, verified through the Calculus Index (CI), Gingival Index (GI), and Plaque Index (PI). Measurements will be performed on vestibular, lingual, mesial, and distal surfaces of all mandibular teeth at T1, 1 month, 3 months, and every 3 months until T2, following Greene & Vermillion (1964) and Löe (1967).;Expected outcome 4 – Patient perception. It is expected that patients treated with ceramic nanotubes will report higher comfort and satisfaction, assessed by a structured 5-point Likert scale questionnaire applied at 7 days, 1 month, 3 months, and at the end of treatment (T2). The questionnaire includes items on adaptation, speech, aesthetics, oral hygiene, comfort, gingival/labial irritation, durability, and overall satisfaction.;Expected outcome 5 – Three-dimensional dentoalveolar effects. It is expected to identify differences in three-dimensional tooth movements between groups in the canine-to-canine region, assessed through digital superimposition of mandibular models (T1 and T2) using 3D Slicer software (version 5.7.0) and CMF registration. Landmarks will be placed on the mucogingival junction and cusp tips, and displacements in x, y, and z axes will be quantified. | — |
Countries
Brazil
Contacts
Public ContactUrsula Pantigozo Morán
Faculdade de Odontologia de Bauru – Universidade de São Paulo
Outcome results
None listed