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Clinical Safety Guidelines for Managing Distal Shoe Complications

Recruitingn/aAges 3 Years - 9 YearsAllUniversity of Florida
NCT07410442 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Distal shoe space maintainers are the standard of care for guiding the eruption of permanent first molars following the premature loss of the primary second molars. Although this therapy represents established clinical practice, prospective evidence regarding soft tissue complications and predictors of treatment outcomes remains limited. This observational study will prospectively collect clinical outcome data during routine treatment visits. The aims of the study are to characterize patterns of complications, evaluate outcomes related to patient adherence, and identify predictors of treatment success. Ultimately, this study seeks to support the development of standardized strategies for clinical monitoring and complication management.

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📋 Eligibility rules (as published)
Inclusion Criteria * Pediatric participants aged 3 to 9 years * American Society of Anesthesiologists (ASA) Physical Status I or II * Clinical indication for distal shoe therapy as the standard of care * Undergoing distal shoe space maintainer placement * Parent or caregiver able to provide consent and comply with follow-up visits Exclusion Criteria * Presence of systemic medical conditions that may affect bone metabolism or wound healing * Patients unable or unwilling to comply with the planned follow-up schedule (up to 24 months) * Patients with contraindications to distal shoe therapy based on clinical judgment
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What it tests

  • Standard Clinical Practice Regimen
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Where

2 sites
Department of Pediatric Dentistry, Universit of Florida, College of Dentistry
Gainesville, United States
University of Florida
Gainesville, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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