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

Recruiting now · Not applicable

Conditions studied: Edentulism, Complete Dentures

In brief

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.

Key facts

Study ID

NCT07579377

Run by

Dow University of Health Sciences

People needed

90

Starts

2025-10-20

Expected to finish

2026-12-30

Last updated by the study team

2026-05-12

Who can join

Age: 40 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Patients seeking conventional complete dentures.
• Aged 40-80 years.
• Both genders (male and female).
• Patient's must be willing to participate in the study and able to attend follow-up appointments

You may not qualify if…

• Patients with severe underlying medical conditions and mental conditions.
• Neuromuscular dysfunction.
• Oral diseases such as denture stomatitis and oral submucous fibrosis
• Xerostomia and tied tongue condition.
• Flabby and Atrophic Ridges.

Where it is running

• Dow University of Health Sciences, Karachi — Karachi, Sindh, Pakistan (enrolling)

Full record on ClinicalTrials.gov

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