Managing complications from distal shoe space maintainers
Soft Tissue Complications and Clinical Decision-Making in Distal Shoe Therapy: A Prospective Clinical Follow-Up Study
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 |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 3 Years to 9 Years |
| Sex | All |
| Sponsor | University of Florida Academic / other |
| Locations | 2 sites (Gainesville, Florida and 1 other locations) |
| Trial ID | NCT07410442 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Gainesville, Florida and 1 other locations
- Department of Pediatric Dentistry, Universit of Florida, College of Dentistry — Gainesville, Florida, United States (Not_yet_recruiting)
- University of Florida — Gainesville, Florida, United States (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.