Clinical Safety Guidelines for Managing Distal Shoe Complications
Recruiting now
Conditions studied: Premature Loss of Primary Molars, Space Maintainer, Soft Tissue Inflammation
In brief
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.
Key facts
- Study ID
- NCT07410442
- Run by
- University of Florida
- People needed
- 50
- Starts
- 2026-08-01
- Expected to finish
- 2029-02-01
- Last updated by the study team
- 2026-07-06
Who can join
Age: 3 and older, up to 9. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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 may not qualify if…
- 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 is running
- University of Florida — Gainesville, Florida, United States (enrolling)
- Department of Pediatric Dentistry, Universit of Florida, College of Dentistry — Gainesville, Florida, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.