[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100557636":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":24,"locations":25,"responsibleParty":57,"collaborators":24,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":24,"eligibilityCriteria":67,"healthyVolunteers":68,"sex":69,"minAge":70,"maxAge":71,"enrollmentInfo":72,"targetDuration":24,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":83,"overallStatus":28,"whyStopped":24,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Universidade Estadual Paulista Júlio de Mesquita Filho","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Diabetic (D)","ACTIVE_COMPARATOR","Palatal wound healing in diabetic patients",[13],"Procedure: Palatal Wound",{"label":15,"type":10,"description":16,"interventionNames":17},"Control Group (CG)","Palatal wound healing in normoglycemic patients",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"PROCEDURE","Palatal Wound","With the goal to harvest the free gingival graft (FGG), an 8mm diameter scalpel will be used to ensure standardized wounds. Thereafter, a 2-mm thick FGG will be removed. The wound area will receive 4.0 silk sutures.",[15,9],null,[26,46],{"facility":27,"status":28,"city":29,"state":30,"zip":31,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"College of Dentistry - São José dos Campos, Sao Paulo State University","RECRUITING","São José dos Campos","São Paulo","12245-310","Brazil","BR",{"type":35,"coordinates":36},"Point",[37,38],-45.88694,-23.17944,{"lat":38,"lon":37},[41],{"name":42,"role":43,"phone":44,"phoneExt":24,"email":45},"Mauro P Santamaria, PhD","CONTACT","55 12 3947 9055","mauro.santamaria@unesp.br",{"facility":47,"status":28,"city":29,"state":30,"zip":48,"country":32,"countryCode":33,"cosmosGeoPoint":49,"geoPoint":51,"contacts":52},"Mauro Pedrine Santamaria and Ana Carolina Ferreira Bonafe","12245000",{"type":35,"coordinates":50},[37,38],{"lat":38,"lon":37},[53],{"name":54,"role":43,"phone":55,"phoneExt":24,"email":56},"Ana Carolina F Bonafe, MS","+55 12 991711401","ana.bonafe@unesp.br",{"type":58,"investigatorFullName":59,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"PRINCIPAL_INVESTIGATOR","Mauro Pedrine Santamaria","Associate Professor","100557636","comparison-of-palatal-wound-healing-in-diabetic-and-non-diabetic-patients-100557636",false,"NCT06540690","Comparison of Palatal Wound Healing in Diabetic and Non-diabetic Patients","Comparison of Palatal Wound Healing in Diabetic and Non-diabetic Patients: Controlled Clinical Trial and in Vitro Study","Inclusion Criteria:\n\n* Patients with at least 18 years, systemically healthy, with good oral hygiene, assessed by plaque index and gingival index less than 25% (Ainamo, Bay, 1975);\n* Patients with no morphological or pathological conditions on the palatine donor area;\n* Patients who present indication for extraction and ridge preservation;\n* The tooth included in the study, as well as, the adjacent teeth do not present loss of periodontal insertion;\n* Patients who agreed to and sign the formal consent to participate in the study after receiving an explanation of risks and benefits from an individual who was not a member of the present study (Resolution no. 118 - May, 2012, and Ethics and Code of Professional Conduct in Dentistry - 118\u002F12).\n* Patients diagnosed with type 2 diabetes for more than 5 years who are using oral hypoglycemic agents or insulin supplementation, with HbA1c levels ranging from ≥ 6.1% to 8.5%.\n* Non-diabetic patients with HbA1c levels below 6.1%.\n\nExclusion Criteria:\n\n* Patients with systemic problems (cardiovascular, blood dyscrasias, immunodeficiency, and diabetes, among others) that will contraindicate the surgical procedure;\n* Patients taking medications known to interfere with the wound healing process or that contraindicate the surgical procedure;\n* Smokers patients;\n* Pregnant or lactating patients;\n* Patients who had had periodontal surgery on the study area;\n* Patients who presents opportunistic oral lesions, mainly colonized the palate region;\n* Use of dental prosthesis with palatal cover;\n* Thin palatal mucosa (\\~2.0mm).",true,"ALL","18 Years","80 Years",{"count":73,"type":74},50,"ESTIMATED","INTERVENTIONAL",[77],"NA","This study aims to characterize and compare the closure of open wounds in the palatal mucosa of diabetic and non-diabetic patients, evaluate clinical, patient-centered and immunological parameters as well as wound microbiome composition.",[80,81,82],"Palate; Wound","Wound Heal","Diabetes",[84,85,86,82],"Periodontology","Wound healing","Controlled Clinical Trial","2024-08-02",{"date":89,"type":90},"2024-08-06","ACTUAL",{"date":92,"type":90},"2023-08-01",{"date":94,"type":74},"2027-01-06",{"name":5,"class":6},2]