Distal Shoe Complications Safety Guidelines Gain Regulatory Clarity From University of Florida Trial

This regulatory update reports safety guidelines for distal shoe devices after premature loss of primary molars, based on a University of Florida trial of a standard clinical practice regimen.

Publication date context: February 15, 2026. A ClinicalTrials.gov listing describes safety guidelines for managing distal shoe complications in pediatric patients who require space maintainers and may experience soft tissue inflammation. The trial describes Premature Loss of Primary Molars as a condition, Space Maintainer as a device element, and Soft Tissue Inflammation as a safety consideration. The intervention is listed as Other: Standard Clinical Practice Regimen, indicating an evaluation of routine care rather than a novel device. The entry states Not yet recruiting and lists the University of Florida as sponsor. Official record details can be found on the ClinicalTrials.gov page linked below.

Official record: ClinicalTrials.gov listing NCT07410442.

What changed in distal shoe safety guidelines?

What is the regulatory intent?

The record centers on three elements: Premature Loss of Primary Molars, Space Maintainer, and Soft Tissue Inflammation. The intervention is described as Other: Standard Clinical Practice Regimen. This suggests the focus is on safety within standard care rather than device modification. The entry notes Not yet recruiting and identifies the University of Florida as sponsor. The description aligns with a regulatory perspective that safety and routine practice are being documented for pediatric space maintainers.

What is the practical effect for clinicians?

Clinicians may rely on established space maintenance protocols and existing device configurations when addressing soft tissue inflammation or early molar loss. The record underscores safety in routine care and supports consistency in how distal shoe components are managed within standard practice.

Who is affected by these guidelines?

Which patient groups are implied?

Pediatric dental patients experiencing premature loss of primary molars who require space maintainers are the implied population. Emphasis on soft tissue inflammation highlights safety considerations for clinicians and caregivers managing these cases.

What are the regulatory implications?

How does this entry relate to regulatory processes?

The description frames a standard clinical practice regimen as the focus of the safety assessment. This aligns with regulatory expectations to document how routine care is delivered in pediatric space maintainer scenarios. The sponsor and the Not yet recruiting status indicate oversight by a major academic center and an early stage evaluation rather than a finished device trial. The official record is accessible via the linked ClinicalTrials.gov page.

What about compliance and safety documentation?

The entry supports the notion that safety is being documented within routine care pathways. This approach facilitates transparency for clinicians and regulators while awaiting recruitment outcomes and any safety data that may be reported.

What safety and performance signals are described?

What is stated about device performance?

The description centers on safety of standard care for distal shoe complications rather than novel performance metrics. There is no indication of new device design changes in the record. The emphasis on standard practice aligns with regulatory norms to capture real world use and adherence to established care pathways.

Who sponsors and what is the trial status?

Who is listed as sponsor?

The University of Florida is named as sponsor in the record. The status Not yet recruiting indicates that participant enrollment has not started.

Where can the official record be found?

The record is hosted on ClinicalTrials.gov and is linked in the source text as well as in this article.

Conclusion

This update conveys that safety oriented guidelines for distal shoe complications are being documented in the context of a standard clinical practice regimen. Because the trial aims to capture routine care rather than device modification, the emphasis remains on patient safety and adherence to established care pathways. Regulators and clinicians should monitor the official record for updates on recruitment status and any reported safety outcomes.

https://clinicaltrials.gov/study/NCT07410442?term=medical+device