The distal shoe space maintainer chairside fabrication and clinical performance.
Warren A Brill
https://pubmed.ncbi.nlm.nih.gov/12528949Actively Recruiting
Age: 3Years - 9Years
All Genders
ID07410442
Soft Tissue Complications and Clinical Decision-Making in Distal Shoe Therapy: A Prospective Clinical Follow-Up Study
Led by University of Florida · Updated on 2026-05-12
50
Participants Needed
2
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying children aged 3 to 9 years who need distal shoe space maintainers, a standard dental device used to guide the proper eruption of permanent first molars after early loss of primary second molars. This observational study aims to gather prospective data on soft tissue complications, patient adherence, and factors predicting treatment success to help develop standardized clinical monitoring and management strategies. Participants receive routine distal shoe therapy as part of their standard dental care, with no experimental changes to the device or procedure. They are monitored at regular follow-up visits, typically at 1 week and every 3 months, to assess gingival health, inflammation, and the eruption of the permanent first molar. Individual participation usually lasts between 12 and 24 months. Throughout the study, clinical data including radiographic measurements, gingival health scores, and caregiver-reported compliance are collected during routine visits. Researchers measure the incidence and severity of soft tissue issues near the appliance, adherence to oral hygiene instructions, appointment attendance, and success in guiding tooth eruption. This comprehensive monitoring supports the development of evidence-based guidelines to optimize treatment outcomes and reduce complications.
CONDITIONS
Brief Title
Clinical Safety Guidelines for Managing Distal Shoe Complications
Who Can Participate
Age: 3Years - 9Years
All Genders
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Monitoring
Duration - 12 to 24 months
Participants who undergo distal shoe therapy as part of routine clinical care are observed to evaluate soft tissue health, gingival inflammation, and the eruption of the permanent first molar.
Follow-up visits at 1 week and every 3 months during monitoring
Trial Site Locations
Total: 2 locations
1
Department of Pediatric Dentistry, Universit of Florida, College of Dentistry
Gainesville, Florida, United States, 32610
Not Yet Recruiting
2
University of Florida
Gainesville, Florida, United States, 32610
Actively Recruiting
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Research Team
M
Mi Sook Lee, DMD, MSD, PhD
M
Marcio Guelmann, DDS
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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