Clinical Safety Guidelines for Managing Distal Shoe Complications
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age3-9
SponsorUniversity of Florida
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Standard Clinical Practice Regimen
Other interventionhis 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.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Distal Shoe Therapy Cohort1 intervention
Trial outcomes
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.
Time frame
From appliance placement until functional eruption of the permanent first molar (typically 12 to 24 months).Secondary outcomes
1
Frequency of missed follow-up appointments per participant
Assessment of patient and caregiver compliance through the systematic tracking of scheduled routine follow-up visits. This measure quantifies the total number of missed appointments during the study period for each participant, reflecting adherence to the prescribed clinical monitoring protocol.
Time frame
From appliance placement until functional eruption of the permanent first molar (typically 12 to 24 months).2
Adherence to oral hygiene instructions based on clinical assessment
Evaluation of patient/caregiver adherence to standardized oral hygiene protocols. Adherence will be assessed during routine follow-up visits and reported as the number of participants who consistently maintain adequate oral hygiene (e.g., meeting predefined clinical criteria for plaque control) throughout the study duration.
Time frame
From appliance placement until functional eruption of the permanent first molar (typically 12 to 24 months).3
Incidence of successful eruption guidance of the permanent first molar
The success of eruption guidance will be determined by verifying the correct anatomical positioning of the permanent first molar. Success is defined by radiographic assessment (bitewing radiographs) and standardized clinical photographs showing the molar in its intended position without impaction or significant mesial drifting. Results will be reported as the number of participants achieving successful eruption guidance.
Time frame
From appliance placement until functional eruption of the permanent first molar (typically 12 to 24 months).Sponsors and contacts
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Source ClinicalTrials.gov