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The Effect of Palatal Rugae Design in Complete Denture on Patient Satisfaction and Quality of Life

StatusRecruiting
PhaseNot applicable
Started
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Record status
This record was last updated May 12, 2026 (before its estimated September 30, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Minor Study First Submitted
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: Do roughened or vacuum-formed thermoplastic sheet palatal rugae designs lead to higher patient satisfaction than the traditional polished design? Do these designs improve oral health-related quality of life, including chewing, speaking, and overall comfort? Researchers 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. Participants will: Receive complete maxillary dentures made with one of the three palatal rugae designs Attend follow-up assessments at 1 week, 1 month, and 3 months after denture insertion (in person or by phone) Complete the OHIP-EDENT questionnaire and a Visual Analog Scale (VAS) to report satisfaction, comfort, and oral health-related quality of life.
Trial Details
NCT Number NCT07579377
Lead Sponsor Dow University of Health Sciences
Conditions
(from sponsor)
Edentulism, Complete Dentures
Enrollment 90 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov