[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"soft-tissue-inflammation\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:soft-tissue-inflammation":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100624500","clinical-safety-guidelines-for-managing-distal-shoe-complications-100624500",false,"NCT07410442","Clinical Safety Guidelines for Managing Distal Shoe Complications","Soft Tissue Complications and Clinical Decision-Making in Distal Shoe Therapy: A Prospective Clinical Follow-Up Study","Inclusion Criteria\n\n* Pediatric participants aged 3 to 9 years\n* American Society of Anesthesiologists (ASA) Physical Status I or II\n* Clinical indication for distal shoe therapy as the standard of care\n* Undergoing distal shoe space maintainer placement\n* Parent or caregiver able to provide consent and comply with follow-up visits\n\nExclusion Criteria\n\n* Presence of systemic medical conditions that may affect bone metabolism or wound healing\n* Patients unable or unwilling to comply with the planned follow-up schedule (up to 24 months)\n* Patients with contraindications to distal shoe therapy based on clinical judgment","ALL","3 Years","9 Years",{"count":20,"type":21},50,"ESTIMATED","OBSERVATIONAL","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.",[25,26,27],"Premature Loss of Primary Molars","Space Maintainer","Soft Tissue Inflammation",[29,30,31],"primary second molar","distal shoe","soft tissue complications","RECRUITING","2026-05-07",{"date":35,"type":36},"2026-05-12","ACTUAL",{"date":38,"type":21},"2026-05",{"date":40,"type":21},"2029-02",{"name":42,"class":43},"University of Florida","OTHER",2]