Clinical Safety Guidelines for Managing Distal Shoe Complications

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.

NCT Number	NCT07410442
Lead Sponsor	University of Florida
Conditions	Premature Loss of Primary Molars, Space Maintainer, Soft Tissue Inflammation
Enrollment	50 participants
Start Date	2026-08
Primary Completion	2028-02 (estimated)
Study Completion	2029-02 (estimated)
Updated on ClinicalTrials.gov	2026-07-06