[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"premature-loss-of-primary-molars\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:premature-loss-of-primary-molars":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"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":5},"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",{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":51,"sex":16,"minAge":17,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":55,"conditions":56,"keywords":60,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":75},"100590312","space-changes-after-premature-loss-of-lower-first-primary-molars-in-children-using-digital-scanning-100590312","NCT06965777","Space Changes After Premature Loss of Lower First Primary Molars in Children Using Digital Scanning","The Space Changes Following Premature Loss of Lower First Primary Molars in the Primary Dentition Stage Using Digital Scanning A Prospective Split-mouth Clinical Study","Inclusion Criteria:\n\n* Children aged 3 to 5.5 years\n* Mandibular first primary molar indicated for extraction due to extensive decay or hopeless prognosis\n* Contralateral mandibular first primary molar must be intact and free of proximal caries\n* No eruption of mandibular permanent first molar at the time of enrollment\n* Presence of primary canines and second primary molars\n* No space maintainers placed\n* Parents\u002Fcaregivers unable or unwilling to fabricate a space maintainer\n\nExclusion Criteria:\n\n* Bilateral premature loss of mandibular first primary molars\n* Contralateral mandibular molar has proximal caries or poor prognosis\n* Children with good prognosis first primary molars (i.e., not needing extraction)\n* Eruption of the mandibular permanent first molar\n* Children who already have space maintainers\n* Uncooperative behavior preventing study participation",true,"66 Months",{"count":54,"type":21},11,"This prospective split-mouth clinical study aims to evaluate space changes in the mandibular dental arch following premature extraction of the lower first primary molar in children aged 3 to 5.5 years. Using digital 3D models, changes in the D space and mandibular arch perimeter will be measured at baseline and 6 months post-extraction. The goal is to determine whether space maintainers are necessary in the primary dentition stage.",[25,57,58,59],"Space Maintenance","Dental Arch Development","Pediatric Tooth Extraction",[61,62,63,64],"Tooth Loss","Dental Arch","Pediatric Dentistry","Primary Dentition","NOT_YET_RECRUITING","2025-05-10",{"date":68,"type":36},"2025-05-14",{"date":70,"type":21},"2025-08-01",{"date":72,"type":21},"2026-03-01",{"name":74,"class":43},"Cairo University",1]