[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100554325":3},{"organization":4,"outcomesModule":7,"designInfo":26,"detailedDescription":29,"studyPopulation":29,"armGroups":37,"interventions":50,"overallOfficials":29,"centralContacts":57,"locations":29,"responsibleParty":63,"collaborators":29,"id":67,"slug":29,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":29,"eligibilityCriteria":72,"healthyVolunteers":68,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":29,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":86,"overallStatus":91,"whyStopped":29,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":29},{"fullName":5,"class":6},"Aga Khan University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":21},[9],{"measure":10,"description":11,"timeFrame":12},"Retention of maxillary denture using digital force meter","Three readings will be taken for each maxillary denture using digital force meter, and an average will be calculated in units for Newton (N) or Kg.m\u002Fs2.","At the delivery appointment for each denture at an average of 2.5 week from the start of denture fabrication and at 8th week (+\u002F- 3 days)",[14,17],{"measure":15,"description":16,"timeFrame":12},"Patient satisfaction with impression methods via the Burdens in Dental Impression-Making Questionnaire (BiDIM-Q)","The questionnaire consists of 12 questions covering various aspects of the impression-making process. Prosthodontists will request patients to score each question from 1 to 100 to gauge their response. A higher score for an aspect of the impression-making procedure will indicate a higher degree of satisfaction.",{"measure":18,"description":19,"timeFrame":20},"Denture satisfaction using the Denture Satisfaction (DS) questionnaire.","The questionnaire comprises 11 questions, answered on a 4-point Likert-type scale to assess the patient's experience with the dentures provided.","At 2 months",[22],{"measure":23,"description":24,"timeFrame":25},"Number of post-insertion visits for denture adjustment","The research team will record the post-delivery visits required to adjust dentures fabricated from two different impression methods in the study Pro-forma.","At the end of adjustment period of each denture at an average of 1-month after denture delivery",{"allocation":27,"interventionModel":28,"interventionModelDescription":29,"primaryPurpose":30,"observationalModel":29,"timePerspective":29,"maskingInfo":31},"RANDOMIZED","CROSSOVER",null,"HEALTH_SERVICES_RESEARCH",{"masking":32,"maskingDescription":29,"whoMasked":33},"TRIPLE",[34,35,36],"PARTICIPANT","CARE_PROVIDER","OUTCOMES_ASSESSOR",[38,44],{"label":39,"type":40,"description":41,"interventionNames":42},"Single step PVS impression","EXPERIMENTAL","Single-step final impression method for complete denture fabrication using medium body PVS for border molding and wash impression in a single-step (i.e., one insertion of impression tray in mouth).",[43],"Procedure: Single step PVS impression",{"label":45,"type":46,"description":47,"interventionNames":48},"Conventional two-step PVS impression","ACTIVE_COMPARATOR","Two-step final impression method for complete denture fabrication, i.e., border molding with heavy-body PVS first, followed by wash impression with light-body PVS.",[49],"Procedure: Conventional two-step PVS impression",[51,54],{"type":52,"name":39,"description":41,"armGroupLabels":53,"otherNames":29},"PROCEDURE",[39],{"type":52,"name":45,"description":55,"armGroupLabels":56,"otherNames":29},"Border molding with heavy-body PVS first, followed by wash impression with light-body PVS",[45],[58],{"name":59,"role":60,"phone":61,"phoneExt":29,"email":62},"Kazmi MR Principle investigator, FCPS","CONTACT","+923212412423","syed.murtaza@aku.edu",{"type":64,"investigatorFullName":65,"investigatorTitle":66,"investigatorAffiliation":5,"oldNameTitle":29,"oldOrganization":29},"PRINCIPAL_INVESTIGATOR","Syed Murtaza Raza Kazmi","Associate Professor","100554325",false,"NCT06497621","Comparing Impression Techniques for Maxillary Complete Denture Retention","Effect of Two Impression Techniques on Retention of Maxillary Complete Denture in Pakistani Population: A Double-blinded Crossover Randomized Controlled Trial","Inclusion Criteria:\n\n* Patients with mild to moderately resorbed maxillary alveolar ridge\n* Patients with bimaxillary edentulous arches\n* Patients aged between 35 to 85 years willing to participate in the study\n* Patients who could be available for follow up visits\n\nExclusion Criteria:\n\n* Patients with palatal torus or bony exostoses or severe undercuts in the maxillary arch\n* Patients with uncontrolled diabetes, osteoporosis, osteomalacia and osteopenia\n* Patients with xerostomia\n* Patients with mucosa covering the denture bearing area with signs of inflammation, ulceration, or hyperplasia.\n* Patients undergoing radiotherapy or chemotherapy or maxillofacial surgery\n* Patients suffering from maxillofacial trauma\n* Patients with neuromuscular disorders\n* Patients with clinical signs and symptoms of temporomandibular joint dysfunction\n* Patients with highly resorbed maxillary ridge and\u002F or flabby ridge\n* Patient with hypersensitivity to silicone materials","ALL","35 Years","80 Years",{"count":77,"type":78},35,"ESTIMATED","INTERVENTIONAL",[81],"NA","The primary objective of this protocol is to compare retention in maxillary complete dentures using single-versus two-step Poly-vinyl Siloxane (PVS) impressions in edentulous patients at denture delivery. Secondary objectives include assessing patient satisfaction with impression methods and denture satisfaction after a two-month adaptation and comparing post-delivery adjustment visits.",[84,85],"Denture Retention","Patient Satisfaction",[87,88,89,90],"Crossover","Complete Denture","Retention","Poly-vinyl siloxane","NOT_YET_RECRUITING","2024-07-04",{"date":94,"type":95},"2024-07-12","ACTUAL",{"date":97,"type":78},"2025-07-01",{"date":99,"type":78},"2027-03-31",{"name":5,"class":6}]