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

NCT07579377 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2026-05-12

No results posted yet for this study

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.

Conditions

  • Edentulism
  • Complete Dentures

Interventions

DEVICE

Polished Palatal Surface Denture

Maxillary complete denture with a traditional polished palatal surface. Fabricated using standard clinical procedures without added rugae or texturing. Serves as the control design in this study and will be compared with roughened and vacuum-formed thermoplastic sheet dentures to assess patient satisfaction, comfort, chewing ability, and oral health-related quality of life.

DEVICE

Roughened Palatal Rugae Design

Maxillary complete denture with a roughened palatal rugae surface. Rugae are intentionally textured to enhance tactile feedback, retention, and comfort. Standard fabrication and fitting procedures are used. Compared with polished and vacuum-formed dentures to evaluate effects on patient satisfaction, comfort, chewing efficiency, and oral health-related quality of life.

DEVICE

Vacuum-Formed Thermoplastic Sheet Rugae Denture

Maxillary complete denture with vacuum-formed thermoplastic sheet palatal rugae. The thermoplastic sheet replicates natural palatal rugae patterns to improve denture retention, comfort, and chewing efficiency. Participants receive standard denture fabrication and fitting. Compared with polished and roughened dentures to assess patient satisfaction, comfort, and oral health-related quality of life.

Sponsors & Collaborators

  • Dow University of Health Sciences

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-10-20
Primary Completion
2026-09-30
Completion
2026-12-30

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07579377 on ClinicalTrials.gov