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Clinical Safety Guidelines for Managing Distal Shoe Complications
Sponsor: University of Florida
Summary
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.
Official title: Soft Tissue Complications and Clinical Decision-Making in Distal Shoe Therapy: A Prospective Clinical Follow-Up Study
Key Details
Gender
All
Age Range
3 Years - 9 Years
Study Type
OBSERVATIONAL
Enrollment
50
Start Date
2026-02
Completion Date
2029-02
Last Updated
2026-02-17
Healthy Volunteers
No
Interventions
Standard Clinical Practice Regimen
his study involves the prospective observational monitoring of clinical outcomes during standard distal shoe therapy. Research activities consist of systematic documentation of clinical data, including radiographic assessment of the intra-alveolar blade depth measured from the mesial margin of the permanent first molar, standardized gingival health scores, and caregiver-reported compliance. No experimental modifications to the clinical device or surgical procedures are performed, ensuring the study reflects routine clinical practice.
Locations (1)
Department of Pediatric Dentistry, Universit of Florida, College of Dentistry
Gainesville, Florida, United States