Recruiting

Observational Study

Sponsor:

University of Florida

Code:

NCT07410442

Conditions

Premature Loss of Primary Molars

Space Maintainer

Soft Tissue Inflammation

Eligibility Criteria

Sex: All

Age: 3 - 9

Healthy Volunteers: Not accepted

Interventions

Standard Clinical Practice Regimen

Study Details

Brief 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

Study ID

NCT07410442

Start date

Aug, 2026

Status verified date

Jul, 2026

Completion date

Feb, 2029

Anticipated

Primary completion date

Feb, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 3 - 9

Healthy Volunteers: Not accepted

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

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.

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 and Locations

Central contacts

Mi Sook Lee, DMD, MSD, PhD

352-273-7643misooklee@ufl.edu

Marcio Guelmann, DDS

352-273-7635mguelmann@dental.ufl.edu

Locations

University of Florida

Recruiting

Gainesville, Florida, United States, 32610

More Information

Sponsor

University of Florida

Last update posted

Jul 6, 2026

Last verified

Jul, 2026

Keywords

  • primary second molar
  • distal shoe
  • soft tissue complications

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Florida on 2026-07-06.