Clinical Safety Guidelines for Managing Distal Shoe Complications

NCT07410442 | Not Yet Recruiting

• 1 other identifier: IRB202600105
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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

Keywords

primary second molar; distal shoe; soft tissue complications

Outcome Measures

Primary Outcomes (1)

• Incidence and severity of soft tissue complications adjacent to the distal shoe appliance

  Assessment of the proportion of participants experiencing localized soft tissue complications and the graded severity of such responses. Evaluation includes the presence of gingival inflammation, ulceration, granulation tissue formation, or clinical signs of infection. These complications will be systematically documented during standardized clinical examinations at each follow-up visit. Severity will be categorized using a defined clinical scale (none, mild, moderate, severe). For participants with multiple symptoms, the overall severity will be reported based on the most severe clinical finding to arrive at one aggregated value per participant.

  From appliance placement until functional eruption of the permanent first molar (typically 12 to 24 months).

Secondary Outcomes (3)

• Frequency of missed follow-up appointments per participant

  From appliance placement until functional eruption of the permanent first molar (typically 12 to 24 months).

• Adherence to oral hygiene instructions based on clinical assessment

  From appliance placement until functional eruption of the permanent first molar (typically 12 to 24 months).

• Incidence of successful eruption guidance of the permanent first molar

  From appliance placement until functional eruption of the permanent first molar (typically 12 to 24 months).

Study Arms (1)

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.

Other: Standard Clinical Practice Regimen

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.

Distal Shoe Therapy Cohort

Eligibility Criteria

• Age: 3 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of pediatric patients recruited from the University of Florida College of Dentistry Pediatric Dental Clinic. Participants are children aged 3 to 9 years, classified as ASA I or II, who require distal shoe therapy as part of their standard clinical care following premature loss of a primary second molar. This population represents a clinical sample of children undergoing established space maintenance procedures under general anesthesia due to behavioral or clinical necessity.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

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

Gainesville, Florida, 32610, United States

Location

Related Publications (1)

• Brill WA. The distal shoe space maintainer chairside fabrication and clinical performance. Pediatr Dent. 2002 Nov-Dec;24(6):561-5.

  PMID: 12528949 BACKGROUND

Related Links

• University of Florida College of Dentistry, Department of Pediatric Dentistry

Study Officials

• Mi Sook Lee, DMD, MSD, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mi Sook Lee, DMD, MSD, PhD

CONTACT

352-273-7643; misooklee@ufl.edu

Marcio Guelmann, DDS

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: February 7, 2026
• First Posted: February 13, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2029
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

US (1)