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Clinical Safety Guidelines for Managing Distal Shoe Complications

NCT07410442 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2026-05-12

No results posted yet for this study

Summary

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

  • Premature Loss of Primary Molars
  • Space Maintainer
  • Soft Tissue Inflammation

Interventions

OTHER

Standard Clinical Practice Regimen

his study involves the prospective observational monitoring of clinical outcomes during standard distal shoe therapy. Research activities consist of systematic documentation of clinical data, including radiographic assessment of the intra-alveolar blade depth measured from the mesial margin of the permanent first molar, standardized gingival health scores, and caregiver-reported compliance. No experimental modifications to the clinical device or surgical procedures are performed, ensuring the study reflects routine clinical practice.

Sponsors & Collaborators

  • University of Florida

    lead OTHER

Principal Investigators

  • Mi Sook Lee, DMD, MSD, PhD · University of Florida

Eligibility

Min Age
3 Years
Max Age
9 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2028-02-29
Completion
2029-02-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07410442 on ClinicalTrials.gov