Clinical Trial

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

Recruiting
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Summary
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 Edentulism, Complete Dentures
Enrollment 90 participants
Start Date 2025-10-20
Primary Completion 2026-09-30 (estimated)
Study Completion 2026-12-30 (estimated)
Updated on ClinicalTrials.gov 2026-05-12