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Clinical Safety Guidelines for Managing Distal Shoe Complications
Soft Tissue Complications and Clinical Decision-Making in Distal Shoe Therapy: A Prospective Clinical Follow-Up Study
Who can join
Ages 3 to 9 · All sexes
Full eligibility criteria
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
About the study
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.
What is being tested
- Standard Clinical Practice Regimen (other)
Sponsor: University of Florida · Participants: 50 · Started: 2026-08
Contact the study team
- Mi Sook Lee, DMD, MSD, PhD · Phone: 352-273-7643
- Marcio Guelmann, DDS · Phone: 352-273-7635
Official record on ClinicalTrials.gov — NCT07410442
Locations in the U.S.
| Florida | Department of Pediatric Dentistry, Universit of Florida, College of Dentistry, Gainesville (Not yet recruiting) University of Florida, Gainesville |
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.