[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100584680":3},{"organization":4,"armGroups":7,"interventions":32,"overallOfficials":62,"centralContacts":66,"locations":75,"responsibleParty":93,"collaborators":37,"id":95,"slug":96,"hasResults":97,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":37,"eligibilityCriteria":101,"healthyVolunteers":97,"sex":102,"minAge":103,"maxAge":37,"enrollmentInfo":104,"targetDuration":37,"studyType":107,"phases":108,"briefSummary":110,"conditions":111,"keywords":114,"overallStatus":77,"whyStopped":37,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":128},{"fullName":5,"class":6},"Virginia Commonwealth University","OTHER",[8,17,22,27],{"label":9,"type":10,"description":11,"interventionNames":12},"Vacuum-formed retainer (VFR): plastic device","EXPERIMENTAL","Subjects will have both dental arches scanned using an intraoral optical scanner to generate the digital model of the jaw.. A resin model will be 3D printed generating the physical model. A palatal stent will be made out of thermoforming plastic in the model using a vacuum, The stent will cover the palate and the anterior and posterior teeth, including their occlusal and buccal surfaces bilaterally, to provide retention. On the day of the surgery, at the final stage of the surgical procedure (after the graft placement and suture of the recipient site), a collagen sponge will be positioned in the palatal wound, and non-resorbable sutures will be placed above the sponge. The previously made plastic palatal stent (VFR) will be placed in position and stabilized by mechanical retention using the palate and maxillary teeth, bilaterally. The subjects will be instructed to wear the stent uninterruptedly in the first 3 days and per their preference on the 4th day and after.",[13,14,15,16],"Other: Visual Analog scale (VAS) questionnaire","Other: Vacuum-formed retainer (VFR) technique","Other: Photographs of the patient's palate","Other: Measuring graft dimensions",{"label":18,"type":10,"description":19,"interventionNames":20},"3-D printed acrylic resin stent (3DS): digitally designed","Subjects will have both dental arches scanned using an intraoral optical scanner to generate the digital model file of the patient's jaws. A palatal stent will be digitally designed. The stent will cover the palatal area to the maximum extent, respecting the limit between the hard and soft palate to avoid any discomfort or gag reflex by the subjects. At the final stage of the surgical procedure (after the graft placement and suture of the recipient site), a collagen sponge will be positioned in the palatal wound, and non-resorbable sutures will be placed above the sponge. The previously made palatal stent (3DS) will be placed in position and stabilized by mechanical retention in the palate and palatal surface of the maxillary teeth, bilaterally.",[13,21,15,16],"Other: 3-D printed acrylic resin stent (3DS) technique",{"label":23,"type":10,"description":24,"interventionNames":25},"Flowable resin composite stent (FRC): mechanical barrier","After the placement of the graft and the suture of the recipient site, a collagen sponge will be positioned in the palatal wound. Then, a layer of cyanoacrylate (PeriAcryl 90HV, GluStitch) will be placed above the sponge using a microbrush. Non-resorbable sutures will be placed covering the palatal dressing, with the suture knots facing the buccal surfaces of the maxillary posterior teeth. Finally, a layer of flowable composite will be added, covering all the wound dimensions, restricted to the wound (no extension to the adjacent teeth). Flowable composite has been shown to help reduce pain using the same principal of providing a mechanical barrier to protect the palatal wound from the oral cavity. Subjects will have both dental arches scanned using an intraoral optical scanner to generate the digital model for secondary analysis.",[13,26,15,16],"Other: Flowable resin composite stent (FRC) technique",{"label":28,"type":10,"description":29,"interventionNames":30},"Chairside Polymer Stent:CPS: mechanical barrier","During the preoperative appoint, both dental arches scanned using an intraoral optical scanner scanner (TRIOS, 3Shape) to generate the digital model in .STL file of the patient's jaws. In this group, the .STL files of the digital models of patient's jaws are not necessary for the fabrication of the stent but will be stored for future analysis of secondary outcomes of the research that includes the healing of the palatal wound via volumetric and linear changes analysis. Before the graft has been harvested, 4 cubes of Zn-containing granules are placed into a warm water bath and manipulated into a 2mm disk and placed in the patient's mouth to be formed to fit the patient. After the graft has been harvested, the stent will be placed directly in the roof of the mouth. Instructions will be provided to the patient about how to remove, place and clean the stent. The patients will be instructed to wear the stent for the first 3 days and per their personal preference on the 4th day and after.",[13,15,16,31],"Other: Chairside Polymer Stent",[33,38,42,46,50,54,58],{"type":6,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"Visual Analog scale (VAS) questionnaire","A Visual Analog Scale (VAS) questionnaire is a type of self-report tool where respondents mark a point on a continuous line to indicate the intensity of a subjective experience, like pain, fatigue, or happiness, between two extreme anchor points (e.g., \"no pain\" at one end and \"worst possible pain\" at the other), allowing for a more nuanced response compared to a standard Likert scale; essentially, it measures the degree of a symptom along a visual continuum.",[18,28,23,9],null,{"type":6,"name":39,"description":40,"armGroupLabels":41,"otherNames":37},"Vacuum-formed retainer (VFR) technique","On the day of surgery, the stent will be positioned to cover the palate and the anterior and posterior teeth, including their occlusal and buccal surfaces bilaterally, to provide retention. Vacuum-formed retainers are a common clinical practice used after harvesting a palatal graft, in order to provide a mechanical barrier to reduce post-operative pain.",[9],{"type":6,"name":43,"description":44,"armGroupLabels":45,"otherNames":37},"3-D printed acrylic resin stent (3DS) technique","On the day of surgery, the previously made palatal stent (3DS) will be placed in position and stabilized by mechanical retention in the palate and palatal surface of the maxillary teeth, bilaterally.",[18],{"type":6,"name":47,"description":48,"armGroupLabels":49,"otherNames":37},"Flowable resin composite stent (FRC) technique","On the day of surgery, a layer of flowable composite will be added, covering all the wound dimensions, restricted to the wound (no extension to the adjacent teeth). Flowable composite has been shown to help reduce pain using the same principal of providing a mechanical barrier to protect the palatal wound from the oral cavity",[23],{"type":6,"name":51,"description":52,"armGroupLabels":53,"otherNames":37},"Photographs of the patient's palate","At the 14-day, 30-day and 3-month follow-up visits, photographs of the patient's palate (Canon EOS 60D DSLR, Canon, USA) will be taken for healing evaluation as well as intraoral scans (TRIOS 4, 3Shape) of the palatal wound for linear and volumetric changes analysis.",[18,28,23,9],{"type":6,"name":55,"description":56,"armGroupLabels":57,"otherNames":37},"Measuring graft dimensions","The graft dimensions will be measured with the use of a periodontal probe and recorded on the data collection form. The professional preference in regard to technique applied and the time spent by the surgeon to adjust the stent intraorally will also be recorded in the same form.",[18,28,23,9],{"type":6,"name":59,"description":60,"armGroupLabels":61,"otherNames":37},"Chairside Polymer Stent","The stent will be placed directly in the roof of the mouth. Instructions will be provided to the patient about how to remove, place and clean the stent. The patients will be instructed to wear the stent for the first 3 days and per their personal preference on the 4th day and after.",[28],[63],{"name":64,"affiliation":5,"role":65},"Rafael Amorim Cavalcanti de Siqueira","PRINCIPAL_INVESTIGATOR",[67,71],{"name":64,"role":68,"phone":69,"phoneExt":37,"email":70},"CONTACT","8046288377","amorimcavalr@vcu.edu",{"name":72,"role":68,"phone":73,"phoneExt":37,"email":74},"Anamika Khosla","8048284868","khoslaar@vcu.edu",[76],{"facility":5,"status":77,"city":78,"state":79,"zip":80,"country":81,"countryCode":82,"cosmosGeoPoint":83,"geoPoint":88,"contacts":89},"RECRUITING","Richmond","Virginia","232398","United States","US",{"type":84,"coordinates":85},"Point",[86,87],-77.46026,37.55376,{"lat":87,"lon":86},[90,92],{"name":64,"role":68,"phone":91,"phoneExt":37,"email":70},"804-628-8377",{"name":72,"role":68,"phone":73,"phoneExt":37,"email":74},{"type":94,"investigatorFullName":37,"investigatorTitle":37,"investigatorAffiliation":37,"oldNameTitle":37,"oldOrganization":37},"SPONSOR","100584680","patient-reported-outcomes-of-donor-site-healing-using-different-palatal-protection-techniques-100584680",false,"NCT06892496","Patient-reported Outcomes of Donor Site Healing Using Different Palatal Protection Techniques","Patient-reported Outcomes of Donor Site Healing Using Different Palatal Protection Techniques: a Randomized Controlled Clinical Trial","Inclusion Criteria:\n\n* At least 18 years of age\n* Healthy or Mild controlled systemic diseases with no functional limitations (ASA I or ASA II)\n* Sites with 1 to 3 teeth or implants requiring soft-tissue grafting\n* Minimum palatal thickness of 2 mm\n* Willing to participate and sign an informed consent\n\nExclusion Criteria:\n\n* Patients with systemic conditions that could impair wound healing (i.e. diabetes, immunosuppressive, chemotherapy, etc.)\n* Pregnant patients\n* Patients with bleeding disorders or taking anticoagulants\n* Smokers\n* Patients with a history of palatal graft harvesting","ALL","18 Years",{"count":105,"type":106},56,"ESTIMATED","INTERVENTIONAL",[109],"NA","This study has been initiated to evaluate the question, \"What is the best way to protect the palate after a gum graft is removed?\" The overall objective is to determine if there is a difference in PROMs of donor site healing using different palatal post-operative protection techniques.",[112,113],"Mucosal Erosion","Gingival Recession",[115,116,117,118],"soft tissue graft","pain","wound healing","CPS: Chairside polymer stent","2026-03-31",{"date":121,"type":122},"2026-04-07","ACTUAL",{"date":124,"type":122},"2025-03-07",{"date":126,"type":106},"2026-07",{"name":5,"class":6},1]