[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100629102":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":28,"locations":34,"responsibleParty":56,"collaborators":11,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":11,"eligibilityCriteria":66,"healthyVolunteers":67,"sex":68,"minAge":69,"maxAge":11,"enrollmentInfo":70,"targetDuration":11,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":81,"overallStatus":85,"whyStopped":11,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"University of Kentucky","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Diabetes group","EXPERIMENTAL",null,[13],"Procedure: Coronally Advance Flap associated with connective tissue graft (CAF+CTG)",{"label":15,"type":16,"description":11,"interventionNames":17},"Non-diabetes group","ACTIVE_COMPARATOR",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":11},"PROCEDURE","Coronally Advance Flap associated with connective tissue graft (CAF+CTG)","A CAF will be performed following the gingival recession (GR) defect features extending beyond the mucogingival junction (MGJ) in a split-full-split thickness design. In sequence, a 2-mm thick free gingival graft (FGG), measuring 15 × 5 mm, will be harvested from the palatal area between the distal of the canine and the mesial aspect of the first molar. The FGG will be trimmed based on the GR defect features and de-epithelialized to achieve a final thickness of 1 mm. The de-epithelialized graft (CTG) will be sutured in position, at the level of the cement-enamel junction (CEJ), using interrupted absorbable sutures. Finally, the flap margin will be repositioned 2 mm coronal to CEJ",[9,15],[25],{"name":26,"affiliation":5,"role":27},"Mauro Santamaria, DDS, MS, PhD","PRINCIPAL_INVESTIGATOR",[29],{"name":30,"role":31,"phone":32,"phoneExt":11,"email":33},"Dawn G Dawson","CONTACT","8593235409","dawn.dawson@uky.edu",[35],{"facility":36,"status":11,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"College of Dentistry - University of Kentucky","Lexington","Kentucky","40536","United States","US",{"type":43,"coordinates":44},"Point",[45,46],-84.47772,37.98869,{"lat":46,"lon":45},[49,53],{"name":50,"role":31,"phone":51,"phoneExt":11,"email":52},"Mauro Pedrine Santamaria, DDS, Ms, PhD","859 323 6297","maurosantamaria@uky.edu",{"name":54,"role":31,"phone":55,"phoneExt":11,"email":33},"Dawn Dawson","859 323-5409",{"type":57,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"SPONSOR_INVESTIGATOR","Mauro Santamaria","Associate Professor","100629102","oral-mucosa-wound-healing-after-gingival-recession-treatment-in-diabetic-patients-a-clinical-study-100629102",false,"NCT07470281","Oral Mucosa Wound Healing After Gingival Recession Treatment in Diabetic Patients. A Clinical Study.","Oral Mucosa Wound Healing in Diabetic Patients. A Clinical Study on Closed Wounds","Inclusion Criteria:\n\n* aged ≥ 18 years;\n* non-diabetic and diabetic patients (HbA1c\\>7% (American Diabetes Association 2025) managed with oral hypoglycemic agents or insulin;\n* in the need of gingival recession treatment (RT1) in upper or lower arches with identifiable or restored cement-enamel junction (CEJ);\n* periodontal stable (BoP ≤25%)(Lang et al. 2003);\n* no morphological or pathological conditions in the palatal mucosa.\n\nExclusion Criteria:\n\n* patients with cardiovascular, blood dyscrasias, and immunodeficiency that contraindicate surgical procedures;\n* taking medications known to interfere with the wound healing process or that contraindicate the surgical procedure;\n* Pregnancy\u002Flactation (assessed via self-report);\n* current opportunistic oral lesions that mainly colonize the palate region;\n* subjects that have taken antibiotics within the last 3 months or need for antibiotic prophylaxis;\n* prisoners;\n* signs or symptoms of active extra-oral head and neck infection (swelling) as determined by a dentist at the time of evaluation;\n* subjects who cannot read or speak English or Spanish, and do not agree to having the assistance of an interpreter",true,"ALL","18 Years",{"count":71,"type":72},40,"ESTIMATED","INTERVENTIONAL",[75],"NA","The goal of this clinical trial is to evaluate local and systemic factors involved in oral mucosal healing after gingival recession treatment in diabetic patients and to compare them with those in non-diabetic patients.\n\nDiabetic and non-diabetic volunteers of both sexes aged ≥ 18 years with gingival recession may participate. The main questions it aims to answer are:\n\n1. If the gingival recession reduction and percentage of root coverage are different in diabetics compared to non-diabetics.\n2. If different factors, such as the oral microbiome, inflammatory markers, and others, are associated with the clinical outcome.\n\nParticipants will be asked:\n\n* Receive the procedure to treat their gingival recession defects\n* To attend follow-up visits at 7, 14, 30, 90, and 180 days after treatment.\n* To provide different biological samples\n* To answer different questionnaires.",[78,79,80],"Diabetes Mellitus","Gingival Recession, Generalized","Gingival Recession, Localized",[82,83,84],"gingival recession","Diabetes","wound healing","NOT_YET_RECRUITING","2026-05-05",{"date":88,"type":89},"2026-05-11","ACTUAL",{"date":91,"type":72},"2026-07",{"date":93,"type":72},"2030-04",{"name":58,"class":6},1]