Clinical Safety Guidelines for Managing Distal Shoe Complications

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age3-9
SponsorUniversity of Florida

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Standard Clinical Practice Regimen

Treatment groups

50 Participants
are divided into 1 treatment group

Sponsors and collaborators