Actively Recruiting
Clinical Safety Guidelines for Managing Distal Shoe Complications
Led by University of Florida · Updated on 2026-05-12
50
Participants Needed
2
Research Sites
143 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Clinical Safety Guidelines for Managing Distal Shoe Complications
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Department of Pediatric Dentistry, Universit of Florida, College of Dentistry
Gainesville, Florida, United States, 32610
Not Yet Recruiting
2
University of Florida
Gainesville, Florida, United States, 32610
Actively Recruiting
Research Team
M
Mi Sook Lee, DMD, MSD, PhD
CONTACT
M
Marcio Guelmann, DDS
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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