[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100652656":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":26,"locations":36,"responsibleParty":55,"collaborators":25,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":25,"eligibilityCriteria":65,"healthyVolunteers":66,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":25,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":25,"overallStatus":81,"whyStopped":25,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Ankara University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Group 1 - Non-smokers","ACTIVE_COMPARATOR","Systemically and periodontally healthy non-smoking patients requiring root coverage treatment due to esthetic concerns or root hypersensitivity, treated with a coronally advanced flap combined with a subepithelial connective tissue graft (CAF + CTG) harvested from the palatal donor site (n = 12).",[13],"Procedure: Coronally Advanced Flap with Subepithelial Connective Tissue Graft (CAF + CTG)",{"label":15,"type":16,"description":17,"interventionNames":18},"Group 2 - Smokers","EXPERIMENTAL","Systemically and periodontally healthy smoking patients requiring root coverage treatment due to esthetic concerns or root hypersensitivity, treated with the same coronally advanced flap combined with a subepithelial connective tissue graft (CAF + CTG) harvested from the palatal donor site (n = 12). Participants are classified as smokers if they report smoking ≥20 cigarettes per day (one pack per day) for at least 5 years, confirmed biochemically by salivary cotinine analysis.",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","Coronally Advanced Flap with Subepithelial Connective Tissue Graft (CAF + CTG)","All defects are treated by a single experienced periodontist using microsurgical All defects are treated by a single experienced periodontist following the technique of Cairo et al. (2012). After local anesthesia, root surfaces are debrided, conditioned with 24% EDTA for 2 minutes, and rinsed. Vertical releasing and intrasulcular incisions are made; a full-thickness flap is raised to the mucogingival junction, then split-thickness dissection allows coronal advancement. A subepithelial connective tissue graft (0.5-1 mm) is harvested from the palate, adapted to the root surface, and secured with sutures, and the flap is positioned 1-2 mm coronal to the cemento-enamel junction.",[9,15],null,[27,32],{"name":28,"role":29,"phone":30,"phoneExt":25,"email":31},"Sivge Kurgan, PhD","CONTACT","+905325495235","sivgeakgun@gmail.com",{"name":33,"role":29,"phone":34,"phoneExt":25,"email":35},"Husna OKTOPCU KARAKOYUN, DDS","+905397835782","husnaansuh34@outlook.com",[37],{"facility":38,"status":25,"city":39,"state":40,"zip":41,"country":42,"countryCode":25,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Ankara University Faculty of Dentistry","Ankara","Yenimahalle","06560","Turkey (Türkiye)",{"type":44,"coordinates":45},"Point",[46,47],32.85427,39.91987,{"lat":47,"lon":46},[50,54],{"name":51,"role":29,"phone":52,"phoneExt":25,"email":53},"Elif Unsal, PhD","+905337627542","unsal.e@gmail.com",{"name":33,"role":29,"phone":34,"phoneExt":25,"email":35},{"type":56,"investigatorFullName":57,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Husna Oktopcu Karakoyun","Research Assistant, Departmant of Periodontology","100652656","evaluation-of-the-effect-of-smoking-on-palatal-donor-site-tissue-profile-in-the-success-of-connective-tissue-grafts-100652656",false,"NCT07777185","Evaluation of the Effect of Smoking on Palatal Donor Site Tissue Profile in the Success of Connective Tissue Grafts","Evaluation of the Effect of Smoking on the Palatal Donor Site Tissue Profile in the Success of Connective Tissue Grafts","Inclusion Criteria\n\nParticipants must be aged 18 years or older and systemically healthy, with no systemic disease that could directly affect inflammatory status or wound healing. Eligible patients must present with an isolated facial recession greater than 2 mm and less than 5 mm (up to a maximum of 5 mm) on non-molar maxillary teeth, classified as Cairo Type 1 (RT1 = Miller Class I and II), meaning gingival recession without interproximal attachment loss. Patients must have had no previous soft tissue surgery at the surgical site, must demonstrate good oral hygiene (full-mouth bleeding on probing below 10%), and must not have had a soft tissue graft previously harvested from the palatal donor site. Finally, participants must be able to comply with all study-related procedures, including attendance at all follow-up visits.\n\nExclusion Criteria\n\nPatients are excluded if they have untreated periodontitis or peri-implantitis, or any systemic disease that could potentially impair wound healing, such as diabetes or connective tissue disorders. Pregnancy or breastfeeding, as well as previous or concurrent use of medications affecting mucosal healing (e.g., steroids or high-dose anti-inflammatory drugs), are also grounds for exclusion. Additional exclusion criteria include coagulation or bleeding disorders, cleft palate, active orthodontic treatment with fixed or removable appliances, a history of malignancy, radiotherapy, or chemotherapy for malignancy within the past 5 years, and antibiotic therapy within the past 6 months. Patients who have previously had a connective tissue graft harvested from the palatal donor site, or who have undergone any other surgical procedure at the palatal donor or recipient site (e.g., apical resection or crown lengthening), are also excluded.",true,"ALL","18 Years","65 Years",{"count":71,"type":72},24,"ESTIMATED","INTERVENTIONAL",[75],"NA","This single-center prospective clinical study investigates how smoking affects palatal donor site tissue biology and, in turn, the success of connective tissue grafts used in root coverage surgery. A total of 24 systemically healthy patients with Cairo Type 1 (RT1) gingival recession will be enrolled: 12 smokers and 12 non-smokers. All participants will receive a coronally advanced flap combined with a subepithelial connective tissue graft (CAF + CTG) harvested from the palatal donor site.\n\nBoth donor and recipient sites will be assessed at baseline and postoperatively (2 weeks, 1 month, and 3 months) using ultra-high frequency ultrasonography (UHFUS) to measure tissue thickness, echogenicity, structural integrity, and vascularization. Residual connective tissue fragments obtained during routine graft preparation will undergo histological, histochemical, and immunohistochemical analysis (including COL1A1, COL1A2, COL3A1, α-SMA, CD31, Factor XIIIa, and IL-33). Smoking status will be biochemically confirmed via salivary cotinine ELISA. Clinical outcomes (recession depth, clinical attachment level, keratinized tissue height, percentage of root coverage) and patient-reported outcome measures (PROMs) will be compared between groups.\n\nPrimary Hypothesis: Smoking negatively affects palatal donor site biology, impairing the clinical and ultrasonographic healing outcomes of CAF + CTG procedures.",[78,79,80],"Soft Tissue Augmentation","Gingival Recession Localized Moderate","Palatal Morphology","NOT_YET_RECRUITING","2026-08-17",{"date":84,"type":85},"2026-08-20","ACTUAL",{"date":87,"type":72},"2026-08-18",{"date":89,"type":72},"2027-02-17",{"name":5,"class":6},1]