Managing complications from distal shoe space maintainers
Official title: Soft Tissue Complications and Clinical Decision-Making in Distal Shoe Therapy: A Prospective Clinical Follow-Up Study
Run by University of Florida · NCT07410442 · Data updated 2026-11-12
This project will collect routine treatment data to see how often and why soft tissue problems happen in children ages 3–9 who receive distal shoe space maintainers after losing a primary second molar.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 3 Years to 9 Years |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | University of Florida Academic / other |
| Locations | 2 sites (Gainesville, Florida and 1 other locations) |
| Status | Recruiting |
| Started | August 2026 |
| Main results expected | February 2028 |
| Study ends | February 2029 |
| Registry record updated | July 6, 2026 |
| Trial ID | NCT07410442 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children aged 3–9 years who are ASA class I or II, have a clinical indication for distal shoe therapy, are undergoing distal shoe placement, and whose parent or caregiver can consent and attend follow-up visits are ideal candidates.
✕Probably not a fit
Patients with systemic conditions that affect bone metabolism or wound healing, those unable to comply with follow-up up to 24 months, or those with clinical contraindications to distal shoe therapy are unlikely to benefit from this project.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective observational project will collect clinical outcome data from pediatric patients receiving distal shoe space maintainers during routine visits at the University of Florida College of Dentistry. Clinicians will record appliance features, soft tissue findings, patient adherence to care instructions, and any complications over follow-up visits lasting up to 24 months. The team will describe patterns and timing of soft tissue complications and analyze which patient- or treatment-related factors predict successful eruption of the permanent first molar. Findings are intended to inform standardized clinical monitoring and complication-management guidance for clinicians.
Why it matters
Potential benefit: If successful, the results could lead to clearer monitoring schedules and treatment guidelines that reduce soft tissue complications and the need for more complex future treatment.
How similar studies have gone: Existing literature is limited to case reports and small retrospective series, so prospective evidence on soft tissue complications and predictors of outcome is currently limited.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
University of Florida
Gainesville, Florida, United States Recruiting -
Department of Pediatric Dentistry, Universit of Florida, College of Dentistry
Gainesville, Florida, United States Not yet recruiting
Study contacts
- Principal investigator: Mi Sook Lee, DMD, MSD, PhD — University of Florida
- Study coordinator: Mi Sook Lee, DMD, MSD, PhD
- Email: misooklee@ufl.edu
- Phone: 352-273-7643
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.