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

NCT07579377 | Recruiting DMC

• 1 other identifier: 65310
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Patient satisfaction measured by Visual Analog Scale (VAS) at 3 months after insertion of complete dentures

  Patient satisfaction with maxillary complete dentures assessed using a Visual Analog Scale (VAS). Participants rate their overall satisfaction on a 100-mm line, where 0 indicates "not satisfied" and 100 indicates "totally satisfied." Higher scores indicate greater satisfaction.

  From enrolment to the end of treatment at 1 week, 3 weeks, 3 months

Secondary Outcomes (1)

• Oral health-related quality of life measured by OHIP-EDENT score at 3 months after insertion of complete dentures with different palatal rugae designs.

  From enrolment to the end of treatment at 1 week, 3 weeks, 3 months

Study Arms (3)

Arm 1: Polished Palatal Surface Denture

EXPERIMENTAL

Maxillary complete denture with a polished palatal surface. The denture is fabricated using standard clinical procedures without added rugae or texturing. This design is being compared with dentures having roughened palatal rugae or vacuum-formed thermoplastic sheet rugae to evaluate differences in patient satisfaction and oral health-related quality of life.

Device: Polished Palatal Surface Denture

Arm 2: Roughened Palatal Rugae Design

EXPERIMENTAL

Maxillary complete denture with a roughened palatal rugae surface. The rugae are intentionally textured to improve tactile feedback, retention, and comfort. Participants receive standard denture fabrication and fitting procedures. This intervention is compared with polished and vacuum-formed thermoplastic sheet dentures to assess effects on patient satisfaction and oral health-related quality of life.

Device: Roughened Palatal Rugae Design

Arm 3: Vacuum-Formed Thermoplastic Rugae Denture

EXPERIMENTAL

Maxillary complete denture with vacuum-formed thermoplastic sheet palatal rugae. The thermoplastic sheet replicates natural palatal rugae patterns, aiming to enhance denture retention, comfort, and chewing efficiency. Participants receive standard denture fabrication and fitting procedures. This intervention is compared with polished and roughened rugae dentures to evaluate patient satisfaction and oral health-related quality of life.

Device: Vacuum-Formed Thermoplastic Sheet Rugae Denture

Interventions

Polished Palatal Surface Denture DEVICE

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.

Arm 1: Polished Palatal Surface Denture

Roughened Palatal Rugae Design DEVICE

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.

Arm 2: Roughened Palatal Rugae Design

Vacuum-Formed Thermoplastic Sheet Rugae Denture DEVICE

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.

Arm 3: Vacuum-Formed Thermoplastic Rugae Denture

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Dow University of Health Sciences: lead

Study Sites (1)

Dow University of Health Sciences, Karachi

Karachi, Sindh, 75500, Pakistan

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label trial. No participants, care providers, investigators, or outcome assessors are masked.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are randomly assigned to one of three parallel groups, each receiving a maxillary complete denture with a different palatal rugae surface design (polished surface, roughened surface, or vacuum-formed thermoplastic rugae). Participants remain in their assigned group throughout the study, and outcomes are compared between groups over a three-month follow-up period.

Study Record Dates

• First Submitted: January 7, 2026
• First Posted: May 12, 2026
• Study Start: October 20, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: May 12, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)