[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100608716":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":31,"centralContacts":35,"locations":40,"responsibleParty":57,"collaborators":10,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":67,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":10,"studyType":74,"phases":10,"briefSummary":75,"conditions":76,"keywords":10,"overallStatus":43,"whyStopped":10,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS","OTHER",[8,14,18,22],{"label":9,"type":10,"description":11,"interventionNames":12},"Pediatric patients in the primary dentition stage",null,"This group includes children who still have all their primary (baby) teeth, with no eruption of permanent teeth. Typically, this stage ranges from approximately 2 to 6 years of age.",[13],"Other: Orthodontic and periodontal analysis",{"label":15,"type":10,"description":16,"interventionNames":17},"Pediatric patients in the early mixed dentition stage","This group includes children in the initial phase of tooth transition, where the first permanent molars and incisors have erupted while primary teeth are still present. This stage generally occurs between 6 and 8 years of age.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Pediatric patients in the late mixed dentition stage","This group consists of children in the later phase of dental transition, when canines and premolars begin to replace primary teeth. It usually occurs between 9 and 12 years of age.",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"Pediatric patients in the permanent dentition stage","This group includes adolescents who have completed the transition and have all or nearly all of their permanent teeth, excluding third molars (wisdom teeth). This stage typically begins around age 12 and up.",[13],[27],{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":10},"Orthodontic and periodontal analysis","Intraoral digital impression aimed at orthodontic analysis and periodontal evaluation using a dedicated periodontal probe, as part of the routine dental examination.",[15,19,23,9],[32],{"name":33,"affiliation":5,"role":34},"Patrizia Gallenzi","PRINCIPAL_INVESTIGATOR",[36],{"name":33,"role":37,"phone":38,"phoneExt":10,"email":39},"CONTACT","+39 0630156358","patrizia.gallenzi@unicatt.it",[41],{"facility":42,"status":43,"city":44,"state":10,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Clinica Odontostomatologica - Fondazione Policlinico IRCSS A. Gemelli","RECRUITING","Roma","00168","Italy","IT",{"type":49,"coordinates":50},"Point",[51,52],11.10642,44.99364,{"lat":52,"lon":51},[55],{"name":56,"role":37,"phone":38,"phoneExt":10,"email":39},"Prof. Patrizia Gallenzi",{"type":58,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100608716","gingival-phenotype-and-dental-crowding-in-pediatric-patients-100608716",false,"NCT07205172","Gingival Phenotype and Dental Crowding in Pediatric Patients","Gingival Phenotype and Dental Crowding in Pediatric Patients, a Pilot Study","BIOTIPO_PEDO","Inclusion Criteria:\n\n* Pediatric patients attending the Pediatric Dentistry and\u002For Orthodontics clinic (consultation and\u002For outpatient appointment).\n* Parents and\u002For legal guardians have signed the informed consent for participation in the study.\n* Age between 5 and 16 years.\n* Clinical dentition criteria by group:\n\nGroup 1 (Primary Dentition): Presence in the mandibular arch of deciduous teeth from canine to canine. Group 2 (Early Mixed Dentition): Presence in the mandibular arch of at least two permanent mandibular incisors, fully erupted (incisal edge at occlusal level) or partially erupted (≥50% of the crown), with no clinical attachment loss, and healthy gingiva or mild gingivitis (Gingival Index, GI ≤ 1). Group 3 (Late Mixed Dentition): Presence in the mandibular arch of all four permanent mandibular incisors fully erupted (incisal edge at occlusal level), with no clinical attachment loss, and healthy gingiva or mild gingivitis (GI ≤\n\n1). Group 4 (Permanent Dentition): Presence in the mandibular arch of all four permanent mandibular incisors fully erupted (incisal edge at occlusal level), with no clinical attachment loss, and healthy gingiva or mild gingivitis (GI ≤ 1).\n\nExclusion Criteria:\n\nPatient-related:\n\n* Parents and\u002For legal guardians have not signed the informed consent.\n* Patients who are not sufficiently cooperative to allow a routine dental examination.\n* Non-cooperative patients, including those with special needs.\n* Children with systemic diseases or undergoing medication that affects gingival tissues.\n* Patients who have already undergone orthodontic treatment or are currently undergoing orthodontic treatment.\n\nTooth-related:\n\n* Presence of dental agenesis or dental anomalies.\n* Dental sites with mucogingival problems.",true,"ALL","5 Years","16 Years",{"count":72,"type":73},180,"ESTIMATED","OBSERVATIONAL","The periodontal phenotype influences treatment outcomes across dental specialties, as tissues of different thickness respond differently to chemical, bacterial, and mechanical insults. In pediatric patients, understanding the gingival phenotype is particularly relevant: a thin phenotype may predispose to dehiscence, fenestration, and gingival recession-especially at the mandibular incisors-when tooth movement exceeds the biological limits of the bony housing.\n\nDuring the mixed dentition phase, significant changes in soft and hard tissues affect tooth position and periodontal stability, making early phenotype assessment essential. Interceptive orthodontics can reduce the long-term risk of mucogingival defects; early identification of a thin biotype allows for preventive strategies, including soft tissue grafting before critical orthodontic movements.\n\nNo studies have examined the association between dental crowding severity and periodontal phenotype in children. Adult data remain inconsistent: Kaya et al. found no correlation between phenotype and skeletal malocclusion, while Kong et al. reported a site-specific association between thin biotype and skeletal Class I\u002FIII at the mandibular central incisor. No predictive model exists for periodontal risk related to severe crowding in childhood.\n\nThis study aims to assess the periodontal phenotype in pediatric patients across different stages of dental transition and to investigate a possible association between a thin periodontal biotype and severe dental crowding.",[77,78],"Crowding, Tooth","Gingival Diseases","2026-05-21",{"date":81,"type":82},"2026-05-26","ACTUAL",{"date":84,"type":82},"2025-12-16",{"date":86,"type":73},"2027-04",{"name":5,"class":6},1]