[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100576187":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":31,"centralContacts":31,"locations":40,"responsibleParty":61,"collaborators":31,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":31,"eligibilityCriteria":71,"healthyVolunteers":67,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":31,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":43,"whyStopped":31,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Izmir Katip Celebi University","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Ora-Aid","EXPERIMENTAL","For the test group, Ora-Aid® measuring 25 mm x 15 mm is used. After achieving hemostasis and irrigating the wound area on the palate with sterile saline, Ora-Aid® is cut to appropriate dimensions to fully cover the wound site. Using tweezers, it is separated from its transparent film layer and applied to the wound. Gentle pressure is applied for 5-10 seconds until the dressing adheres to the wound site. To enhance the stabilization of Ora-Aid® in the area, it is secured using 4\u002F0 silk sutures with a cross-suture technique.",[13],"Device: Ora-Aid-Oral Wound Dressing",{"label":15,"type":16,"description":17,"interventionNames":18},"L-PRF","ACTIVE_COMPARATOR","For the L-PRF group, venous blood is collected from patients using a disposable sterile syringe and placed into glass tubes without anticoagulants. The blood samples are centrifuged at 2700 rpm for 12 minutes in a centrifuge device. After the centrifugation process is completed, the clot formed in the middle layer of the tube is removed using tweezers and placed between two sterile metal plates to be compressed into a membrane. The dimensions of the obtained L-PRF membrane are adjusted according to the size of the donor site. The wound area on the palate is sutured crosswise using 4\u002F0 silk suture material, and the L-PRF membrane is placed on the wound surface.",[19],"Biological: Platelet rich fibrin",{"label":21,"type":16,"description":22,"interventionNames":23},"Palatal Stent","For the palatal stent group, impressions are taken from patients preoperatively, and a plate is prepared. The fit of the plate is checked in the oral cavity. After the free gingival graft is harvested, hemostasis is achieved at the wound site, and the palatal stent is placed on the maxilla.",[24],"Device: Palatal Stent",[26,32,37],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DEVICE","Ora-Aid-Oral Wound Dressing","Intended as a physical barrier for temporary protection of oral mucosal tissue and to provide pain relief. This product is a non-eugenol protective material applied to intraoral wounds. Ora-Aid is a new concept of pasting intra-oral patch to protect the affected area such as post implant, extraction, orthodontic, and ulcers. This new concept of pasting intra-oral wound dressing is designed to protect the affected area and aid natural healing.",[9],null,{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":31},"BIOLOGICAL","Platelet rich fibrin","It has been reported that the use of Platelet-Rich Fibrin (PRF) to cover palatal wounds accelerates healing and reduces postoperative morbidity. Studies have demonstrated that PRF supports key processes in wound healing, such as \"immunity,\" \"angiogenesis,\" and \"cellular proliferation.\" Its use has garnered significant interest, particularly in non-healing wounds and areas left to heal by secondary intention after surgery. Leukocyte and Platelet-Rich Fibrin (L-PRF) is frequently used in periodontal surgical applications. The platelets and growth factors it contains accelerate the healing process and facilitate tissue repair.",[15],{"type":27,"name":21,"description":38,"armGroupLabels":39,"otherNames":31},"Palatal stents help prevent complications such as infection or excessive discomfort. These plates are typically customized to fit the patient's palate by taking impressions before the surgery. Once placed, they serve as a barrier, especially during the early stages of healing. Additionally, they may reduce the need for postoperative interventions, such as the use of strong painkillers.",[21],[41],{"facility":42,"status":43,"city":44,"state":31,"zip":31,"country":45,"countryCode":31,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Izmir Katip Celebi University Faculty of Dentistry Department of Periodontology","RECRUITING","Izmir","Turkey (Türkiye)",{"type":47,"coordinates":48},"Point",[49,50],27.13838,38.41273,{"lat":50,"lon":49},[53,58,59],{"name":54,"role":55,"phone":56,"phoneExt":31,"email":57},"Sare Eröz, Research Assistant","CONTACT","+90 (537) 648 9064","sareeroz@gmail.com",{"name":54,"role":55,"phone":31,"phoneExt":31,"email":31},{"name":60,"role":55,"phone":31,"phoneExt":31,"email":31},"Şükrü Enhoş, Professor Dr.",{"type":62,"investigatorFullName":63,"investigatorTitle":64,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"PRINCIPAL_INVESTIGATOR","Sare Eröz","Research Assistant","100576187","the-effect-of-periodontal-dressings-and-various-materials-on-the-donor-sites-quality-of-life-after-free-gingival-graft-surgery-100576187",false,"NCT06782035","The Effect of Periodontal Dressings and Various Materials on the Donor Site's Quality of Life After Free Gingival Graft Surgery","The Influence of Periodontal Dressings (Ora-Aid) and Various Materials on the Donor Site's Quality of Life After Free Gingival Graft Surgery","Inclusion Criteria:\n\nSystemically healthy Non-smoker Insufficient attached gingiva Not using any medication regularly Age 18-85 years No previous graft taken from the same area Not in pregnancy or lactation period Agreement to participate in the study and sign the \"Informed Consent Form\"\n\nExclusion Criteria:\n\nSystemic disease Regular systemic medication use Under 18 years old Pregnant or breastfeeding women Smoker Previous graft taken from the same area","ALL","18 Years","85 Years",{"count":76,"type":77},36,"ESTIMATED","INTERVENTIONAL",[80],"NA","The inadequate width of attached gingiva, resulting from the loss of the attached gingiva band, is one of the primary mucogingival issues. Free gingival graft (FGG) is a mucogingival surgical technique used to increase the amount of attached gingiva, cover exposed root surfaces in localized gingival recessions, deepen the vestibule, and eliminate frenulum and muscle attachments. The harvested tissue is keratinized attached gingiva. Due to ease of access, the palate is most commonly preferred as the donor site.\n\nComplications that may arise following FGG surgery are generally donor site-related. Reported complications include postoperative bleeding, recurrent herpetic lesions, delayed healing, paresthesia, mucocele, arteriovenous shunt, and postoperative pain. To aid healing and reduce discomfort and pain associated with the wound site in the palate after surgery, various materials have been applied to the donor site to facilitate recovery.\n\nFollowing FGG surgery, patients will be divided into three groups based on the application of different materials to the wound site in the palate: leukocyte- and platelet-rich fibrin (L-PRF), Ora-Aid oral wound dressing, and a palatal surgical stent. In the Ora-Aid group, after harvesting the graft and placing it in the recipient site, the wound area will be irrigated with saline solution, and Ora-Aid will be trimmed to the appropriate size and shape. It will be gently pressed onto the wound for 5-10 seconds until it adheres. Ora-Aid and L-PRF will be secured to the wound site with a 4\u002F0 silk cross suture. The Ora-Aid application will serve as the test group, the L-PRF application as the positive control group, and the palatal surgical stent as the negative control group. Randomization will be performed using a computer program.\n\nPostoperatively, patients' pain levels will be assessed on the 3rd, 7th, and 14th days using the Visual Analog Scale (VAS) test and the OHIP-14 questionnaire. Wound site epithelialization will be evaluated during follow-up sessions on the 7th and 14th days and at 1 month. After evaluating all questionnaire results, statistical analyses will be conducted.",[83],"Recession, Gingival",[85,86,87],"Free gingival graft","Mucogingival surgery","Periodontal dressing","2025-01-13",{"date":90,"type":91},"2025-01-17","ACTUAL",{"date":93,"type":91},"2025-01-02",{"date":95,"type":77},"2025-05-25",{"name":5,"class":6},1]