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This research investigates children aged 10 to 11 years who have one or both upper permanent canine teeth displaced towards the palate, a condition affecting 2-3% of children where adult canine teeth fail to erupt properly. The study aims to evaluate whether early orthodontic treatments can prevent the need for later surgery by correcting the position of these displaced teeth. Previous evidence for treatments is limited, so this trial compares different approaches to improve outcomes and reduce complications such as damage to nearby teeth or the need for invasive surgery. Participants will be randomly assigned to one of three groups: no treatment (control), removal of the primary (baby) canine tooth, or creation of space for the adult tooth using orthodontic devices such as fixed appliances with open coils or rapid maxillary expansion. The space creation involves specific activation schedules, including daily adjustments for 14 days followed by alternate-day activations. In Sweden, patients having the baby canine removed will also receive a space-maintaining appliance to preserve dental arch space during the 18-month observation period. Throughout the study, various assessments will be done including standardized dental radiographs and cone beam computed tomography scans at baseline, 12 months, and 18 months to monitor tooth position, eruption success, and any root damage. Digital or study dental casts will also be used to assess space in the dental arch. The primary outcome is the rate of successful eruption without surgery 18 months after treatment begins. Secondary outcomes include cost-effectiveness, quality of life measures, and incidence of damage or adverse effects. The trial plans to enroll 324 children across multiple centers in Sweden, Germany, and the UK.

Age: 10Years - 12YearsAll GendersPhase Not Applicable
3 locations
Traben Trarbach Clinical Trials | DecenTrialz