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

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.

Study Overview

• Status: Recruiting
• Conditions: Edentulism; Complete Dentures
• Intervention / Treatment: Device: Polished Palatal Surface Denture; Device: Roughened Palatal Rugae Design; Device: Vacuum-Formed Thermoplastic Sheet Rugae Denture

Detailed Description

Edentulism, the complete loss of natural teeth, remains a significant public health concern due to its profound impact on oral function, speech, comfort, and psychosocial well-being. Although dental implants provide a favorable treatment option for many edentulous patients, financial limitations, medical contraindications, and inadequate bone structure often prevent their use. Consequently, conventional complete dentures continue to serve as the primary option for oral rehabilitation in a large proportion of patients.

In conventional maxillary complete dentures, the palatal surface plays an essential role in retention, support, and stability. However, full palatal coverage may also reduce tactile sensitivity and compromise patient comfort, speech clarity, and the ability to perceive taste and temperature. The natural palate contains palatal rugae-elevated folds rich in mechanoreceptors that contribute to oral proprioception and assist in guiding tongue movements during speech, swallowing, and mastication. In contrast, the palatal surface of a conventional denture is typically smooth, which may limit the tongue's ability to adapt effectively to the prosthesis.

Multiple techniques have been proposed to incorporate palatal rugae patterns into complete dentures, including tin-foil duplication, dental floss carving, silicone putty impressions, small palatal windows, roughening procedures, and vacuum-formed templates. While each method offers certain benefits, they also present limitations such as material instability, operator sensitivity, cost, or the need for additional laboratory steps. Previous research comparing polished, roughened, and open rugae designs has shown that designs with greater tactile feedback may improve user satisfaction and oral health-related quality of life (OHRQoL), whereas excessive modification-such as open rugae windows-may reduce comfort and function. Despite these findings, limited evidence is available regarding the comparative effectiveness of polished, roughened, and vacuum-formed thermoplastic rugae designs in maxillary complete dentures.

This randomized controlled trial aims to address this gap by evaluating how three different palatal rugae textures-polished, roughened, and vacuum-formed thermoplastic sheet-affect patient satisfaction and OHRQoL among complete denture wearers. Ninety participants will be randomly allocated into one of three groups. All dentures will be fabricated using standard clinical and laboratory protocols, with the only experimental variation occurring in the palatal rugae region.

The polished-surface group will receive dentures with a conventional smooth palatal surface finished with standard pumice polishing. The roughened-surface group will receive dentures in which the rugae area is textured using 120-µm aluminum oxide sandblasting at 2 bar for 10 seconds. The vacuum-formed group will receive dentures incorporating a rugae pattern created from a 0.5-mm thermoplastic sheet molded over a cast and transferred to the waxed denture before processing. These three designs represent accessible, commonly used techniques with potential clinical benefits in recreating natural palatal anatomy.

Participants will be evaluated at one week, one month, and three months after denture insertion. During each follow-up, participants will complete the OHIP-EDENT questionnaire to assess the impact of the denture on daily function, psychosocial well-being, and oral discomfort. A Visual Analog Scale (VAS) will also be used to measure subjective satisfaction with comfort, chewing, speech, esthetics, and overall denture experience. Clinical assessments will include denture fit, speech clarity, comfort, mucosal condition, and any necessary adjustments.

The primary outcome of the study is the difference in OHIP-EDENT scores among the three rugae design groups over time. Secondary outcomes include VAS-based satisfaction scores and patient-reported ease of adaptation. Through this structured comparison, the study aims to determine whether incorporating specific palatal rugae textures can improve comfort, enhance sensory feedback, aid speech articulation, and contribute positively to oral health-related quality of life.

Ultimately, this research seeks to inform evidence-based improvements in complete denture design, offering clinicians practical guidance for selecting palatal rugae configurations that enhance patient experience and long-term adaptation.

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan, 75500
      • Recruiting
      • Dow University of Health Sciences, Karachi
      • Contact: Aqsa s Aqsa Saeed Khan, BDS; Phone Number: 0330-8170509 aqsasaeedkhan5@gmail.com; Email: aqsasaeedkhan5@gmail.com
      • Principal Investigator: Aqsa saeed Aqsa Saeed Khan, bds

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1: Polished Palatal Surface Denture; 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; 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.
Experimental: Arm 2: Roughened Palatal Rugae Design; 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; 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.
Experimental: Arm 3: Vacuum-Formed Thermoplastic Rugae Denture; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oral health-related quality of life measured by OHIP-EDENT score at 3 months after insertion of complete dentures with different palatal rugae designs.	Oral health-related quality of life will be assessed using the 20-item OHIP-EDENT questionnaire at 3 months post-insertion of complete dentures with polished, roughened, or vacuum-formed palatal rugae designs. Scores will range from 20 (best) to 100 (worst), with lower scores indicating better quality of life. This measure will evaluate the impact of different palatal rugae textures on patients' comfort, function, and overall oral health-related quality of life over time	From enrolment to the end of treatment at 1 week, 3 weeks, 3 months

Collaborators and Investigators

• Sponsor: Dow University of Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: January 7, 2026
• First Submitted That Met QC Criteria: May 7, 2026
• First Posted (Actual): May 12, 2026

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 65310

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No