[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100640075":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":30,"centralContacts":30,"locations":39,"responsibleParty":63,"collaborators":30,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":69,"acronym":30,"eligibilityCriteria":70,"healthyVolunteers":71,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":30,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":30,"overallStatus":42,"whyStopped":30,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Dow University of Health Sciences","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm 1: Polished Palatal Surface Denture","EXPERIMENTAL","Maxillary complete denture with a polished palatal surface. The denture is fabricated using standard clinical procedures without added rugae or texturing. This design is being compared with dentures having roughened palatal rugae or vacuum-formed thermoplastic sheet rugae to evaluate differences in patient satisfaction and oral health-related quality of life.",[13],"Device: Polished Palatal Surface Denture",{"label":15,"type":10,"description":16,"interventionNames":17},"Arm 2: Roughened Palatal Rugae Design","Maxillary complete denture with a roughened palatal rugae surface. The rugae are intentionally textured to improve tactile feedback, retention, and comfort. Participants receive standard denture fabrication and fitting procedures. This intervention is compared with polished and vacuum-formed thermoplastic sheet dentures to assess effects on patient satisfaction and oral health-related quality of life.",[18],"Device: Roughened Palatal Rugae Design",{"label":20,"type":10,"description":21,"interventionNames":22},"Arm 3: Vacuum-Formed Thermoplastic Rugae Denture","Maxillary complete denture with vacuum-formed thermoplastic sheet palatal rugae. The thermoplastic sheet replicates natural palatal rugae patterns, aiming to enhance denture retention, comfort, and chewing efficiency. Participants receive standard denture fabrication and fitting procedures. This intervention is compared with polished and roughened rugae dentures to evaluate patient satisfaction and oral health-related quality of life.",[23],"Device: Vacuum-Formed Thermoplastic Sheet Rugae Denture",[25,31,35],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DEVICE","Polished Palatal Surface Denture","Maxillary complete denture with a traditional polished palatal surface. Fabricated using standard clinical procedures without added rugae or texturing. Serves as the control design in this study and will be compared with roughened and vacuum-formed thermoplastic sheet dentures to assess patient satisfaction, comfort, chewing ability, and oral health-related quality of life.",[9],null,{"type":26,"name":32,"description":33,"armGroupLabels":34,"otherNames":30},"Roughened Palatal Rugae Design","Maxillary complete denture with a roughened palatal rugae surface. Rugae are intentionally textured to enhance tactile feedback, retention, and comfort. Standard fabrication and fitting procedures are used. Compared with polished and vacuum-formed dentures to evaluate effects on patient satisfaction, comfort, chewing efficiency, and oral health-related quality of life.",[15],{"type":26,"name":36,"description":37,"armGroupLabels":38,"otherNames":30},"Vacuum-Formed Thermoplastic Sheet Rugae Denture","Maxillary complete denture with vacuum-formed thermoplastic sheet palatal rugae. The thermoplastic sheet replicates natural palatal rugae patterns to improve denture retention, comfort, and chewing efficiency. Participants receive standard denture fabrication and fitting. Compared with polished and roughened dentures to assess patient satisfaction, comfort, and oral health-related quality of life.",[20],[40],{"facility":41,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Dow University of Health Sciences, Karachi","RECRUITING","Karachi","Sindh","75500","Pakistan","PK",{"type":49,"coordinates":50},"Point",[51,52],67.0104,24.8608,{"lat":52,"lon":51},[55,60],{"name":56,"role":57,"phone":58,"phoneExt":59,"email":58},"Aqsa s Aqsa Saeed Khan, BDS","CONTACT","aqsasaeedkhan5@gmail.com","0330-8170509",{"name":61,"role":62,"phone":30,"phoneExt":30,"email":30},"Aqsa saeed Aqsa Saeed Khan, bds","PRINCIPAL_INVESTIGATOR",{"type":64,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100640075","the-effect-of-palatal-rugae-design-in-complete-denture-on-patient-satisfaction-and-quality-of-life-100640075",false,"NCT07579377","The Effect of Palatal Rugae Design in Complete Denture on Patient Satisfaction and Quality of Life","Inclusion Criteria:\n\n1. Patients seeking conventional complete dentures.\n2. Aged 40-80 years.\n3. Both genders (male and female).\n4. Patient's must be willing to participate in the study and able to attend follow-up appointments\n\nExclusion Criteria:\n\n1. Patients with severe underlying medical conditions and mental conditions.\n2. Neuromuscular dysfunction.\n3. Oral diseases such as denture stomatitis and oral submucous fibrosis\n4. Xerostomia and tied tongue condition.\n5. Flabby and Atrophic Ridges.",true,"ALL","40 Years","80 Years",{"count":76,"type":77},90,"ESTIMATED","INTERVENTIONAL",[80],"NA","The goal of this clinical trial is to learn whether different palatal rugae designs in complete dentures can improve comfort, function, and overall oral health-related quality of life in edentulous adults aged 40 to 80 years. The main questions it aims to answer are:\n\nDo roughened or vacuum-formed thermoplastic sheet palatal rugae designs lead to higher patient satisfaction than the traditional polished design?\n\nDo these designs improve oral health-related quality of life, including chewing, speaking, and overall comfort?\n\nResearchers will compare three denture designs-a polished palatal surface, a roughened palatal surface, and a vacuum-formed thermoplastic sheet rugae design-to see which design provides better comfort, function, and quality of life for patients.\n\nParticipants will:\n\nReceive complete maxillary dentures made with one of the three palatal rugae designs\n\nAttend follow-up assessments at 1 week, 1 month, and 3 months after denture insertion (in person or by phone)\n\nComplete the OHIP-EDENT questionnaire and a Visual Analog Scale (VAS) to report satisfaction, comfort, and oral health-related quality of life.",[83,84],"Edentulism","Complete Dentures","2026-05-07",{"date":87,"type":88},"2026-05-12","ACTUAL",{"date":90,"type":88},"2025-10-20",{"date":92,"type":77},"2026-12-30",{"name":5,"class":6},1]