RecruitingNCT07410442

Clinical Safety Guidelines for Managing Distal Shoe Complications

Soft Tissue Complications and Clinical Decision-Making in Distal Shoe Therapy: A Prospective Clinical Follow-Up Study


Sponsor

University of Florida

Enrollment

50 participants

Start Date

Aug 1, 2026

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 3 YearsMax Age: 9 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Standard Clinical Practice Regimen for people with premature loss of primary molars, soft tissue inflammation, and other related conditions. The study is currently recruiting participants at 2 locations. People eligible for this study include aged 3 Years to 9 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERStandard 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.


Locations(2)

Department of Pediatric Dentistry, Universit of Florida, College of Dentistry

Gainesville, Florida, United States

University of Florida

Gainesville, Florida, United States

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NCT07410442


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