[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100595563":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":24,"locations":24,"responsibleParty":25,"collaborators":30,"id":36,"slug":37,"hasResults":38,"nctId":39,"briefTitle":40,"officialTitle":41,"acronym":42,"eligibilityCriteria":43,"healthyVolunteers":44,"sex":45,"minAge":46,"maxAge":47,"enrollmentInfo":48,"targetDuration":24,"studyType":51,"phases":52,"briefSummary":54,"conditions":55,"keywords":57,"overallStatus":60,"whyStopped":24,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":24},{"fullName":5,"class":6},"Pakistan Institute of Medical Sciences","OTHER_GOV",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"with palatal rugae initially","EXPERIMENTAL","Received maxillary complete denture with palatal rugae first, followed by a smooth polished palatal surface denture after a 2-month adaptation period.",[13],"Device: complete dentures",{"label":15,"type":10,"description":16,"interventionNames":17},"without palatal rugae initially","Received a smooth polished palatal surface denture first, followed by a rugae-enhanced denture after a 2-month adaptation period.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DEVICE","complete dentures","Participants were randomly allocated into two intervention sequences using a computer-generated randomization list. The two sequences were:\n\n* Group A: Received maxillary complete denture with palatal rugae first, followed by a smooth polished palatal surface denture after a 2-month adaptation period.\n* Group B: Received a smooth polished palatal surface denture first, followed by a rugae-enhanced denture after a 2-month adaptation period.",[9,15],null,{"type":26,"investigatorFullName":27,"investigatorTitle":28,"investigatorAffiliation":29,"oldNameTitle":24,"oldOrganization":24},"PRINCIPAL_INVESTIGATOR","Chawla Rashmi","Resident","Shaheed Zulfiqar Ali Bhutto Medical University",[31,34],{"name":32,"class":33},"School of dentistry","UNKNOWN",{"name":35,"class":33},"Shaheed Zulfiqar Ali Bhutto Medical University Islamabad Pakistan","100595563","phase-2-the-impact-of-palatal-rugae-addition-to-complete-dentures-on-patients-satisfaction-and-oral-health-related-quality-of-life-100595563",false,"NCT07034079","The Impact of Palatal Rugae Addition to Complete Dentures on Patients' Satisfaction and Oral Health Related Quality of Life","The Impact of Palatal Rugae Addition to Complete Dentures on Patients' Satisfaction and Oral Health Related Quality of Life: A Randomized Crossover Clinical Trial","Palatal rugae","Inclusion Criteria:\n\n* Patients aged 45-80 years.\n* Completely edentulous for at least 3 months.\n* Seeking new complete maxillary dentures for the first time.\n* Provided written informed consent\n* Motivated and compliant patients, willing to return for follow-up (helps reduce attrition bias)\n* Patients with Class I maxillomandibular relationship\n\nEXCLUSION CRITERIA\n\n* Patients with severe systemic diseases or neuromuscular dysfunction.\n* Presence of mental or auditory impairment.\n* History of oral pathology, xerostomia, or ankyloglossia (tied tongue).\n* Previous or experienced complete denture wearers.\n* Patient with strong gag reflex",true,"ALL","40 Years","80 Years",{"count":49,"type":50},60,"ESTIMATED","INTERVENTIONAL",[53],"PHASE2","In conventional maxillary complete dentures, the palatal surface is typically smooth and polished, lacking the natural anatomy of the palatal rugae. While this design facilitates ease of cleaning, it may compromise the functional feedback required for speech and other oral functions. Since the palatal rugae contain mechanoreceptors essential for guiding the tongue during phonation and mastication, replicating these structures may enhance oral function and patient adaptation.\n\nGiven the variation in clinical outcomes reported in prior studies, a randomized crossover clinical trial is warranted to assess the impact of adding anatomically replicated palatal rugae to complete dentures.",[56],"Edentulism",[42,58,56,59],"Oral health impact profile","complete denture","NOT_YET_RECRUITING","2026-06-04",{"date":63,"type":64},"2026-06-08","ACTUAL",{"date":66,"type":50},"2026-07-01",{"date":68,"type":50},"2026-12-31",{"name":5,"class":6}]