[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100569802":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":27,"centralContacts":32,"locations":22,"responsibleParty":41,"collaborators":22,"id":43,"slug":44,"hasResults":45,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":45,"sex":51,"minAge":52,"maxAge":22,"enrollmentInfo":53,"targetDuration":22,"studyType":56,"phases":57,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":68,"whyStopped":22,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":22},{"fullName":5,"class":6},"Assistance Publique - Hôpitaux de Paris","OTHER",[8,13],{"label":9,"type":6,"description":10,"interventionNames":11},"Simplified(PS)\u002FConventional(PC)","Complete removable denture according to the simplified protocol (PS) in period 1 (3 months), 1 month of wash-out then complete removable denture according to the conventional protocol (PC) in period 2 (3 months).",[12],"Other: Simplified protocol (PS)\u002FConventional protocol (PC)",{"label":14,"type":6,"description":15,"interventionNames":16},"Conventional(PC)\u002FSimplified (PS)","Complete removable denture according to the conventional protocol (PC) in period 1 (3 months), 1 month of wash-out then complete removable denture according to the simplified protocol (PS) in period 2 (3 months).",[17],"Other: Conventional protocol (PC)\u002FSimplified protocol (PS)",[19,23],{"type":6,"name":20,"description":10,"armGroupLabels":21,"otherNames":22},"Simplified protocol (PS)\u002FConventional protocol (PC)",[9],null,{"type":6,"name":24,"description":25,"armGroupLabels":26,"otherNames":22},"Conventional protocol (PC)\u002FSimplified protocol (PS)","Complete removable denture according to the conventional protocol (PC) in period 1 (3 months), 1 month of wash-out then complete removable denture according to the simplified protocol (PS)in period 2 (3 months).",[14],[28],{"name":29,"affiliation":30,"role":31},"Christophe RIGNON-BRET","APHP","STUDY_DIRECTOR",[33,37],{"name":29,"role":34,"phone":35,"phoneExt":22,"email":36},"CONTACT","06 79 17 67 30","rignonbret@gmail.com",{"name":38,"role":34,"phone":39,"phoneExt":22,"email":40},"Isabelle FOUILLOUX-PATEY","06 60 67 46 37","Isabelle.fouilloux@gmail.com",{"type":42,"investigatorFullName":22,"investigatorTitle":22,"investigatorAffiliation":22,"oldNameTitle":22,"oldOrganization":22},"SPONSOR","100569802","simplified-technique-in-removable-complete-prosthesis-versus-conventional-technique-in-edentulous-patients-100569802",false,"NCT06698978","Simplified Technique in Removable Complete Prosthesis Versus Conventional Technique in Edentulous Patients","Interest of a Simplified Technique in Removable Complete Prosthesis Versus Conventional Technique in Edentulous Patients: a Multicenter Randomized Clinical Trial in Cross-over.","IDEFIX","Inclusion Criteria:\n\n* Patients 18 years\n* Complete single-maxillary (upper or lower arcade) or bimaxillar (upper and lower arcade) edentesis paired with non-iatrogenic removable full dentures (possibly readapted)\n* Edentulous arcade with healthy or sanitized mucosa\n* Sufficient inter arcade space\n* Free and informed consent\n* Adequate understanding of written and spoken French\n* Membership of a social security scheme\n\nExclusion Criteria:\n\n* Patient unable to cooperate\n* Presence of pathological lesions of the oral mucosa\n* Parkinson's disease\n* Gougerot-Sjögren's disease,\n* Patient with cancer of the upper aerogribogastic tract\n* Patient in psychiatric care\n* Patient with neurological disease (vascular algia of the face, trigeminal neuralgia,...)\n* Patient with xerostomia\n* Allergy identified to resin\n* Patient deprived of liberty by judicial or administrative decision\n* Patient under legal protection (guardianship, curatorship)\n* Patient under AME (State Medical Aid)","ALL","18 Years",{"count":54,"type":55},62,"ESTIMATED","INTERVENTIONAL",[58],"NA","This study compares a simplified complete removable denture technique (PS) to the conventional approach (PC) in edentulous patients. The goal is to demonstrate that the simplified technique is not inferior to the conventional method in terms of quality of life, measured by the OHIP-20 scale over three months. The trial also examines time, satisfaction, denture quality, cost, and masticatory performance.\n\nDesign:\n\nThis is a multicenter, randomized, cross-over study with 62 patients over 11 months of participation, including a one-month washout between treatments. Patients will receive both types of dentures, with the order randomized.\n\nPopulation:\n\nThe trial targets edentulous patients, both uni- and bi-maxillary, aged 18 or older, with certain health and dental conditions.\n\nKey Assessments:\n\nQuality of Life: OHIP-20 scores are collected pre-treatment and after three months for each denture type.\n\nPatient Satisfaction and Denture Quality: Assessed using modified Kapur criteria and patient satisfaction surveys.\n\nMasticatory Performance: Evaluated with a chewing gum test. Medical Economic Impact: Cost analysis of each denture type.\n\nAnticipated Outcomes:\n\nBenefits include reducing costs and treatment times, enhancing accessibility to dentures, particularly for elderly and underserved populations, and adapting dental education to teach this simplified technique.\n\nCenters Involved:\n\nSeven centers across France, including AP-HP hospitals and private practices.\n\nTimeline:\n\nThe inclusion period is 24 months, with a total study duration of 35 months.",[61],"Complete Edentulism",[63,64,65,66,67],"removable prosthesis","simplified technique","cross-over","edentulous patients","conventional technique","NOT_YET_RECRUITING","2024-11-19",{"date":71,"type":72},"2024-11-21","ACTUAL",{"date":74,"type":55},"2025-01-01",{"date":76,"type":55},"2028-03-01",{"name":5,"class":6}]