Clinical Safety Guidelines for Managing Distal Shoe Complications

Conditions

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

Eligibility Criteria

Sex

ALL

Age

3 Years - 9 Years

Healthy Volunteers

Not accepted

Interventions

• Standard Clinical Practice Regimen — OTHER
  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.

Study Details

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 Dates

Start date

May 31, 2026

Status verified

Feb 2026

Primary completion

Feb 29, 2028

Completion

Feb 28, 2029

Study Design

Enrollment

50 participants (estimated)

Arms

• Arm: Distal Shoe Therapy Cohort
  This cohort includes pediatric patients, aged 3 to 9 years (ASA I or II), for whom distal shoe therapy has been clinically indicated as the standard of care (SOC). Participants undergo routine appliance fabrication and placement as part of their standard clinical care. The cohort will be prospectively monitored during SOC follow-up visits (at 1-week and 3-month intervals) to evaluate soft tissue health, gingival inflammation, and the successful eruption of the permanent first molar. Individual participation typically ranges from 12 to 24 months.

Primary Outcome Measure

Incidence and severity of soft tissue complications adjacent to the distal shoe appliance [ Time Frame: From appliance placement until functional eruption of the permanent first molar (typically 12 to 24 months). ]

Central Contacts

• Mi Sook Lee, DMD, MSD, PhD
  352-273-7643
  [email protected]
• Marcio Guelmann, DDS
  352-273-7635
  [email protected]

Locations (2)

Find similar trials in Gainesville, FL